Trial Outcomes & Findings for Inhaled Sargramostim in Treating Patients With First Pulmonary (Lung) Recurrence of Osteosarcoma (NCT NCT00066365)
NCT ID: NCT00066365
Last Updated: 2015-03-30
Results Overview
FAS ligand (FASL) is a homotrimeric type II transmembrane protein expressed on cytotoxic T lymphocytes. The Cluster of Differentiation 1a (CD1a) status is measured in Immunohistochemistry (IHC) categories.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
49 participants
Primary outcome timeframe
29 days after start of protocol therapy
Results posted on
2015-03-30
Participant Flow
Participant milestones
| Measure |
Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy
Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
conventional surgery: thoracotomy
|
Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy
Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
conventional surgery: thoracotomy
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
18
|
|
Overall Study
COMPLETED
|
8
|
4
|
|
Overall Study
NOT COMPLETED
|
23
|
14
|
Reasons for withdrawal
| Measure |
Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy
Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
conventional surgery: thoracotomy
|
Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy
Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
conventional surgery: thoracotomy
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
15
|
12
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
No viable tumor after 1 cycle of therapy
|
2
|
0
|
|
Overall Study
Ineligible
|
4
|
2
|
Baseline Characteristics
Inhaled Sargramostim in Treating Patients With First Pulmonary (Lung) Recurrence of Osteosarcoma
Baseline characteristics by cohort
| Measure |
Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy
n=31 Participants
Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
conventional surgery: thoracotomy
|
Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy
n=18 Participants
Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
conventional surgery: thoracotomy
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
25 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
16 years
n=5 Participants
|
17 years
n=7 Participants
|
16 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
18 participants
n=7 Participants
|
48 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 29 days after start of protocol therapyPopulation: Patients who were enrolled in the unilateral recurrence group do not contribute to the assessment of any "Pre Chemotherapy" analysis. Such patients only had tissue for assessment after the first thoracotomy which was planned for 22 days after the start of sargramostim treatment. 14 patients were evaluated for this primary outcome measure.
FAS ligand (FASL) is a homotrimeric type II transmembrane protein expressed on cytotoxic T lymphocytes. The Cluster of Differentiation 1a (CD1a) status is measured in Immunohistochemistry (IHC) categories.
Outcome measures
| Measure |
Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy
Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
conventional surgery: thoracotomy
|
Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy
n=14 Participants
Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
conventional surgery: thoracotomy
|
|---|---|---|
|
Status of FAS Ligand in Pre-chemotherapy Sample
IHC Category 0
|
—
|
7 participants
|
|
Status of FAS Ligand in Pre-chemotherapy Sample
IHC Category 1
|
—
|
5 participants
|
|
Status of FAS Ligand in Pre-chemotherapy Sample
IHC Category 2
|
—
|
1 participants
|
|
Status of FAS Ligand in Pre-chemotherapy Sample
IHC Category 3
|
—
|
1 participants
|
PRIMARY outcome
Timeframe: 29 days after start of protocol therapyPopulation: Patients who were enrolled in Group 1 (unilateral recurrence) do not contribute to the assessment of any "Pre Chemotherapy" analysis. Such patients only had tissue for assessment after the first thoracotomy which was planned for 22 days after the start of sargramostim treatment.
FAS/APO-1 is a transmembrane receptor. The presence is measured in Immunohistochemistry (IHC) categories.
Outcome measures
| Measure |
Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy
Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
conventional surgery: thoracotomy
|
Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy
n=14 Participants
Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
conventional surgery: thoracotomy
|
|---|---|---|
|
Presence of FAS in Pre-chemotherapy Sample
IHC Category 0
|
—
|
5 participants
|
|
Presence of FAS in Pre-chemotherapy Sample
IHC Category 1
|
—
|
5 participants
|
|
Presence of FAS in Pre-chemotherapy Sample
IHC Category 2
|
—
|
2 participants
|
|
Presence of FAS in Pre-chemotherapy Sample
IHC Category 3
|
—
|
2 participants
|
PRIMARY outcome
Timeframe: 29 days after start of protocol therapyPopulation: 22 patients from the unilateral recurrence group and 13 patients from the bilateral recurrence group were evaluated for this outcome measure.
FAS ligand or FASL is a homotrimeric type II transmembrane protein expressed on cytotoxic T lymphocytes. The presence is measured in Immunohistochemistry (IHC) categories.
Outcome measures
| Measure |
Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy
n=22 Participants
Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
conventional surgery: thoracotomy
|
Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy
n=13 Participants
Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
conventional surgery: thoracotomy
|
|---|---|---|
|
FAS Ligand in Post Chemotherapy Sample
IHC Category 0
|
16 participants
|
7 participants
|
|
FAS Ligand in Post Chemotherapy Sample
IHC Category 1
|
4 participants
|
2 participants
|
|
FAS Ligand in Post Chemotherapy Sample
IHC Category 2
|
1 participants
|
2 participants
|
|
FAS Ligand in Post Chemotherapy Sample
IHC Category 3
|
1 participants
|
2 participants
|
PRIMARY outcome
Timeframe: 29 days after start of protocol therapyPopulation: 22 patients from the unilateral recurrence group and 13 patients from the bilateral recurrence group were evaluated for this outcome measure.
FAS/APO-1 is a transmembrane receptor. The presence is measured in Immunohistochemistry (IHC) categories.
Outcome measures
| Measure |
Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy
n=22 Participants
Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
conventional surgery: thoracotomy
|
Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy
n=13 Participants
Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
conventional surgery: thoracotomy
|
|---|---|---|
|
FAS Status in Post Chemotherapy Sample
IHC Category 0
|
14 participants
|
5 participants
|
|
FAS Status in Post Chemotherapy Sample
IHC Category 1
|
4 participants
|
4 participants
|
|
FAS Status in Post Chemotherapy Sample
IHC Category 2
|
1 participants
|
0 participants
|
|
FAS Status in Post Chemotherapy Sample
IHC Category 3
|
3 participants
|
4 participants
|
PRIMARY outcome
Timeframe: 29 days after start of protocol therapyPopulation: Patients enrolled in the unilateral recurrence group do not contribute to the assessment of any "Pre Chemotherapy" analysis. Such patients only had tissue for assessment after the first thoracotomy which was planned for 22 days after the start of sargramostim treatment. 7 patients were evaluated from the bilateral recurrence group.
CD1a (Cluster of Differentiation 1a) is a human protein encoded by the CD1A gene, presence is measured by positivity.
Outcome measures
| Measure |
Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy
Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
conventional surgery: thoracotomy
|
Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy
n=7 Participants
Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
conventional surgery: thoracotomy
|
|---|---|---|
|
CD1a Status in Pre Chemotherapy Sample
Negative
|
—
|
5 participants
|
|
CD1a Status in Pre Chemotherapy Sample
Focally Positive
|
—
|
2 participants
|
PRIMARY outcome
Timeframe: 29 days after start of protocol therapyPopulation: 20 patients were evaluated for this outcome measure from the unilateral group and 7 patients were evaluated from the bilateral group.
CD1a (Cluster of Differentiation 1a) is a human protein encoded by the CD1A gene, presence is measured by positivity.
Outcome measures
| Measure |
Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy
n=20 Participants
Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
conventional surgery: thoracotomy
|
Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy
n=7 Participants
Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
conventional surgery: thoracotomy
|
|---|---|---|
|
CD1a Status in Post Chemotherapy Sample
Negative
|
8 participants
|
5 participants
|
|
CD1a Status in Post Chemotherapy Sample
Focally Positive
|
12 participants
|
2 participants
|
PRIMARY outcome
Timeframe: 29 days after start of protocol therapyPopulation: Patients enrolled in the unilateral recurrence group do not contribute to the assessment of any "Pre Chemotherapy" analysis. Such patients only had tissue for assessment after the first thoracotomy which was planned for 22 days after the start of sargramostim treatment. 7 patients were evaluated from the bilateral recurrence group.
The S-100 proteins are a family of low-molecular-weight proteins characterized by two calcium-binding sites that have helix-loop-helix ("EF-hand type") conformation.
Outcome measures
| Measure |
Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy
Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
conventional surgery: thoracotomy
|
Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy
n=7 Participants
Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
conventional surgery: thoracotomy
|
|---|---|---|
|
S100 Status in Pre Chemotherapy Sample
Negative
|
—
|
4 participants
|
|
S100 Status in Pre Chemotherapy Sample
Focally Positive
|
—
|
3 participants
|
PRIMARY outcome
Timeframe: 29 days after start of protocol therapyPopulation: 20 patients from the unilateral recurrence group and 10 patients from the bilateral recurrence group were evaluated for this outcome measure.
The S-100 proteins are a family of low-molecular-weight proteins characterized by two calcium-binding sites that have helix-loop-helix ("EF-hand type") conformation.
Outcome measures
| Measure |
Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy
n=20 Participants
Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
conventional surgery: thoracotomy
|
Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy
n=10 Participants
Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
conventional surgery: thoracotomy
|
|---|---|---|
|
S100 Status in Post Chemotherapy Sample
Negative
|
17 participants
|
9 participants
|
|
S100 Status in Post Chemotherapy Sample
Focally Positive
|
3 participants
|
1 participants
|
PRIMARY outcome
Timeframe: 29 days after start of protocol therapyPopulation: Patients enrolled in the unilateral recurrence group do not contribute to the assessment of any "Pre Chemotherapy" analysis. Such patients only had tissue for assessment after the first thoracotomy which was planned for 22 days after the start of sargramostim treatment. 7 patients were measured from the bilateral recurrence group.
The protein encoded by this gene can under some stress conditions also be found in the cell cytosol. It has been suggested to be involved in several basic biological events such as cell death, tumor progression, and neurodegenerative disorders.
Outcome measures
| Measure |
Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy
Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
conventional surgery: thoracotomy
|
Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy
n=7 Participants
Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
conventional surgery: thoracotomy
|
|---|---|---|
|
Clusterin Status in Pre Chemotherapy Sample
Negative
|
—
|
5 participants
|
|
Clusterin Status in Pre Chemotherapy Sample
Focally Positive
|
—
|
2 participants
|
PRIMARY outcome
Timeframe: 29 days after start of protocol therapyPopulation: This outcome measure was evaluated in 30 patients, 20 patients in the unilateral recurrence group and 10 patients in bilateral recurrence group.
Outcome measures
| Measure |
Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy
n=20 Participants
Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
conventional surgery: thoracotomy
|
Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy
n=10 Participants
Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
conventional surgery: thoracotomy
|
|---|---|---|
|
Clusterin Status in Post Chemotherapy Sample
Negative
|
17 participants
|
7 participants
|
|
Clusterin Status in Post Chemotherapy Sample
Focally Positive
|
3 participants
|
3 participants
|
PRIMARY outcome
Timeframe: Time of enrollment to Event or 5 years from enrollment, whichever occurs firstPopulation: There were 4 ineligible unilateral patients and 2 ineligible bilateral patients not included in this analysis.
EFS defined as the time from enrollment on the study until disease progression, occurrence of a second malignant neoplasm (SMN), death or last contact, whichever comes first. Disease progression, occurrence of a SMN or death will be considered an analytic even. In all other cases, the patient will be considered censored at last contact.
Outcome measures
| Measure |
Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy
n=27 Participants
Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
conventional surgery: thoracotomy
|
Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy
n=16 Participants
Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
conventional surgery: thoracotomy
|
|---|---|---|
|
Event Free Survival (EFS)
|
.57 years
Interval 0.31 to 0.68
|
.33 years
Interval 0.19 to 0.49
|
PRIMARY outcome
Timeframe: Enrollment through 21 days of protocol therapyPopulation: This outcome measure was calculated for eligible patients only. This yields 27 patients for assessment of this measure in Group 1 and 16 patients for assessment of this measure in Group 2.
Feasibility success defined as received 21 days of protocol therapy, did not experience grade III or grade IV toxicity according to Common Toxicity Criteria for Adverse Events (CTCAE) version 3 and rendered surgically free of disease in the lungs.
Outcome measures
| Measure |
Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy
n=27 Participants
Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
conventional surgery: thoracotomy
|
Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy
n=16 Participants
Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
conventional surgery: thoracotomy
|
|---|---|---|
|
Feasibility Success
Yes
|
24 participants
|
16 participants
|
|
Feasibility Success
No
|
3 participants
|
0 participants
|
Adverse Events
Group 1 (Unilateral Recurrence)
Serious events: 4 serious events
Other events: 8 other events
Deaths: 0 deaths
Group 2 (Bilateral Recurrence)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1 (Unilateral Recurrence)
n=27 participants at risk
(See Detailed Description and Interventions for drugs, dosages, delivery method and frequency.)
sargramostim: given by inhalation
conventional surgery: thoracotomy
|
Group 2 (Bilateral Recurrence)
n=16 participants at risk
(See Detailed Description and Interventions for drugs, dosages, delivery method and frequency.)
sargramostim: given by inhalation
conventional surgery: thoracotomy
|
|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
3.7%
1/27
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
0.00%
0/16
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
|
Investigations
Aspartate aminotransferase increased
|
3.7%
1/27
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
0.00%
0/16
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
|
Investigations
Creatinine increased
|
3.7%
1/27
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
0.00%
0/16
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.7%
1/27
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
0.00%
0/16
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
|
Investigations
Forced expiratory volume decreased
|
3.7%
1/27
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
0.00%
0/16
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
3.7%
1/27
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
0.00%
0/16
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
|
Vascular disorders
Hypotension
|
3.7%
1/27
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
0.00%
0/16
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
3.7%
1/27
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
0.00%
0/16
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
|
Injury, poisoning and procedural complications
Postoperative hemorrhage
|
3.7%
1/27
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
0.00%
0/16
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
3.7%
1/27
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
0.00%
0/16
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
Other adverse events
| Measure |
Group 1 (Unilateral Recurrence)
n=27 participants at risk
(See Detailed Description and Interventions for drugs, dosages, delivery method and frequency.)
sargramostim: given by inhalation
conventional surgery: thoracotomy
|
Group 2 (Bilateral Recurrence)
n=16 participants at risk
(See Detailed Description and Interventions for drugs, dosages, delivery method and frequency.)
sargramostim: given by inhalation
conventional surgery: thoracotomy
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
3.7%
1/27
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
0.00%
0/16
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
|
Blood and lymphatic system disorders
Anemia
|
3.7%
1/27
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
0.00%
0/16
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other
|
3.7%
1/27
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
0.00%
0/16
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
3.7%
1/27
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
0.00%
0/16
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.4%
2/27
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
0.00%
0/16
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.4%
2/27
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
0.00%
0/16
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
|
Investigations
Forced expiratory volume decreased
|
0.00%
0/27
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
18.8%
3/16
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
|
Injury, poisoning and procedural complications
Fracture
|
3.7%
1/27
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
0.00%
0/16
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.7%
1/27
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
0.00%
0/16
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
3.7%
1/27
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
0.00%
0/16
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
3.7%
1/27
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
0.00%
0/16
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.7%
1/27
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
0.00%
0/16
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.7%
1/27
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
0.00%
0/16
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
3.7%
1/27
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
0.00%
0/16
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
|
Infections and infestations
Infections and infestations - Other
|
3.7%
1/27
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
0.00%
0/16
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.7%
1/27
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
0.00%
0/16
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
|
Investigations
Neutrophil count decreased
|
3.7%
1/27
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
0.00%
0/16
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
|
General disorders
Non-cardiac chest pain
|
11.1%
3/27
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
0.00%
0/16
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
|
General disorders
Pain
|
3.7%
1/27
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
0.00%
0/16
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
|
Investigations
Platelet count decreased
|
3.7%
1/27
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
0.00%
0/16
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.7%
1/27
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
0.00%
0/16
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
3.7%
1/27
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
0.00%
0/16
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/27
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
6.2%
1/16
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
|
Investigations
Vital capacity abnormal
|
0.00%
0/27
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
12.5%
2/16
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
|
Investigations
White blood cell decreased
|
3.7%
1/27
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
0.00%
0/16
SAE field contains NCI Common Toxicity Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. AE counts only based on eligible patients
|
Additional Information
Results Reporting Coordinator
Children's Oncology Group
Phone: 626-447-0064
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Must obtain prior Sponsor approval.
- Publication restrictions are in place
Restriction type: OTHER