Trial Outcomes & Findings for Cryotherapy and GM-CSF in Treating Patients With Lung Metastases or Primary Lung Cancer (NCT NCT00514215)
NCT ID: NCT00514215
Last Updated: 2020-03-05
Results Overview
CT-guided biopsy \& Peritumoral GM-CSF. a CR was defined as involution of the prior tumor and/or ablation site to only a thin, non-enhancing scar within the pulmonary parenchyma on enhanced chest CT. A PR was defined as incomplete resolution of an otherwise thoroughly hypovascular resolving ablation zone which had reached a diameter smaller than the original tumor size. Stable disease (SD) reflects no significant change in size of ablation site and/or overall tumor burden, while the standard definition for progressive disease (PD) remains as evidence of neTw or growing tumors.
COMPLETED
PHASE2
8 participants
Days 1 & 32
2020-03-05
Participant Flow
Participant milestones
| Measure |
Sargramostim, Flow Cytometry, Biopsy. Cryosurgery
Sargramostim-250 μg, inhaled, two times a day, on days 4-10 and days 36-42 Flow cytometry-Days 1 \& 32 Immunoenzyme technique-Days 1 \& 32 CT guided biopsy-Days 1 \& 32 Cryosurgery-Days 1 and 32
sargramostim: 250 μg, inhaled, two times a day, on days 4-10 and days 36-42
flow cytometry: Days 1 \& 32
immunoenzyme technique: Days 1 \& 32
biopsy: CT guided biopsy on days 1 \& 32
cryosurgery: Days 1 and 32
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cryotherapy and GM-CSF in Treating Patients With Lung Metastases or Primary Lung Cancer
Baseline characteristics by cohort
| Measure |
Sargramostim, Flow Cytometry, Biopsy. Cryosurgery
n=8 Participants
Sargramostim-250 μg, inhaled, two times a day, on days 4-10 and days 36-42 Flow cytometry-Days 1 \& 32 Immunoenzyme technique-Days 1 \& 32 CT guided biopsy-Days 1 \& 32 Cryosurgery-Days 1 and 32
sargramostim: 250 μg, inhaled, two times a day, on days 4-10 and days 36-42
flow cytometry: Days 1 \& 32
immunoenzyme technique: Days 1 \& 32
biopsy: CT guided biopsy on days 1 \& 32
cryosurgery: Days 1 and 32
|
|---|---|
|
Age, Continuous
|
55 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Days 1 & 32Population: Patients who had metastatic Renal Cell carcinoma
CT-guided biopsy \& Peritumoral GM-CSF. a CR was defined as involution of the prior tumor and/or ablation site to only a thin, non-enhancing scar within the pulmonary parenchyma on enhanced chest CT. A PR was defined as incomplete resolution of an otherwise thoroughly hypovascular resolving ablation zone which had reached a diameter smaller than the original tumor size. Stable disease (SD) reflects no significant change in size of ablation site and/or overall tumor burden, while the standard definition for progressive disease (PD) remains as evidence of neTw or growing tumors.
Outcome measures
| Measure |
Sargramostim, Flow Cytometry, Biopsy. Cryosurgery
n=6 Participants
Sargramostim-250 μg, inhaled, two times a day, on days 4-10 and days 36-42 Flow cytometry-Days 1 \& 32 Immunoenzyme technique-Days 1 \& 32 CT guided biopsy-Days 1 \& 32 Cryosurgery-Days 1 and 32
sargramostim: 250 μg, inhaled, two times a day, on days 4-10 and days 36-42
flow cytometry: Days 1 \& 32
immunoenzyme technique: Days 1 \& 32
biopsy: CT guided biopsy on days 1 \& 32
cryosurgery: Days 1 and 32
|
|---|---|
|
Immunologic Response as Measured by ELISPOT Assay and Flow Cytometry
Complete Response
|
1 Participants
|
|
Immunologic Response as Measured by ELISPOT Assay and Flow Cytometry
Partial Response
|
3 Participants
|
|
Immunologic Response as Measured by ELISPOT Assay and Flow Cytometry
Progressive Disease
|
2 Participants
|
SECONDARY outcome
Timeframe: Days 1 & 32Population: only those with metastatic Renal Cell carcinoma
CT-guided biopsy. a CR was defined as involution of the prior tumor and/or ablation site to only a thin, non-enhancing scar within the pulmonary parenchyma on enhanced chest CT. A PR was defined as incomplete resolution of an otherwise thoroughly hypovascular resolving ablation zone which had reached a diameter smaller than the original tumor size. Stable disease (SD) reflects no significant change in size of ablation site and/or overall tumor burden, while the standard definition for progressive disease (PD) remains as evidence of neTw or growing tumors.
Outcome measures
| Measure |
Sargramostim, Flow Cytometry, Biopsy. Cryosurgery
n=6 Participants
Sargramostim-250 μg, inhaled, two times a day, on days 4-10 and days 36-42 Flow cytometry-Days 1 \& 32 Immunoenzyme technique-Days 1 \& 32 CT guided biopsy-Days 1 \& 32 Cryosurgery-Days 1 and 32
sargramostim: 250 μg, inhaled, two times a day, on days 4-10 and days 36-42
flow cytometry: Days 1 \& 32
immunoenzyme technique: Days 1 \& 32
biopsy: CT guided biopsy on days 1 \& 32
cryosurgery: Days 1 and 32
|
|---|---|
|
Clinical Response as Measured by CT Criteria
Complete Response
|
1 Participants
|
|
Clinical Response as Measured by CT Criteria
Partial Response
|
3 Participants
|
|
Clinical Response as Measured by CT Criteria
Progressive Disease
|
2 Participants
|
SECONDARY outcome
Timeframe: Days 11, 32, 43, & 63Number of Participants with Toxicity of Grade 1 or Higher as defined by CTCAE v2
Outcome measures
| Measure |
Sargramostim, Flow Cytometry, Biopsy. Cryosurgery
n=8 Participants
Sargramostim-250 μg, inhaled, two times a day, on days 4-10 and days 36-42 Flow cytometry-Days 1 \& 32 Immunoenzyme technique-Days 1 \& 32 CT guided biopsy-Days 1 \& 32 Cryosurgery-Days 1 and 32
sargramostim: 250 μg, inhaled, two times a day, on days 4-10 and days 36-42
flow cytometry: Days 1 \& 32
immunoenzyme technique: Days 1 \& 32
biopsy: CT guided biopsy on days 1 \& 32
cryosurgery: Days 1 and 32
|
|---|---|
|
Toxicity of Grade 1 or Higher
Alergic Reaction
|
1 Participants
|
|
Toxicity of Grade 1 or Higher
Allergic rhinitis
|
2 Participants
|
|
Toxicity of Grade 1 or Higher
Anemia
|
1 Participants
|
|
Toxicity of Grade 1 or Higher
Anorexia
|
1 Participants
|
|
Toxicity of Grade 1 or Higher
Atelectasis
|
1 Participants
|
|
Toxicity of Grade 1 or Higher
Bronchospasm, wheezing
|
1 Participants
|
|
Toxicity of Grade 1 or Higher
Chest Pain (noncardiac, nonpleuritic)
|
1 Participants
|
|
Toxicity of Grade 1 or Higher
Chest wall pain
|
6 Participants
|
|
Toxicity of Grade 1 or Higher
Cough
|
7 Participants
|
|
Toxicity of Grade 1 or Higher
Decreased platelets
|
1 Participants
|
|
Toxicity of Grade 1 or Higher
Dizziness
|
1 Participants
|
|
Toxicity of Grade 1 or Higher
Dyspnea
|
4 Participants
|
|
Toxicity of Grade 1 or Higher
Fatigue
|
4 Participants
|
|
Toxicity of Grade 1 or Higher
Hemoptysis
|
1 Participants
|
|
Toxicity of Grade 1 or Higher
Hemorrhage, pulmonary lung (hemoptysis)
|
4 Participants
|
|
Toxicity of Grade 1 or Higher
Hyperglycemia
|
1 Participants
|
|
Toxicity of Grade 1 or Higher
Low grade fever
|
1 Participants
|
|
Toxicity of Grade 1 or Higher
Lymphopenia
|
2 Participants
|
|
Toxicity of Grade 1 or Higher
Nausea
|
1 Participants
|
|
Toxicity of Grade 1 or Higher
Pain at incision site
|
1 Participants
|
|
Toxicity of Grade 1 or Higher
Pain-upper resp. throat
|
2 Participants
|
|
Toxicity of Grade 1 or Higher
Platelets Low
|
1 Participants
|
|
Toxicity of Grade 1 or Higher
Pneumothorax
|
4 Participants
|
|
Toxicity of Grade 1 or Higher
Sensory Neuropathy
|
1 Participants
|
|
Toxicity of Grade 1 or Higher
Shortness of Breath
|
1 Participants
|
|
Toxicity of Grade 1 or Higher
Sweating
|
1 Participants
|
|
Toxicity of Grade 1 or Higher
Thrombocytopenia
|
1 Participants
|
|
Toxicity of Grade 1 or Higher
Vomiting
|
1 Participants
|
SECONDARY outcome
Timeframe: Days 1 & 63Population: only those with metastatic Renal Cell carcinoma
Number of Participants with CT-guided biopsy \& Peritumoral GM-CSF. The number of IFNγ secreting T-cells was measured by a direct EliSpots at 10:1 E:T ratio to define the kinetics of the CTL responses from pre-CI to day 63 post CI.
Outcome measures
| Measure |
Sargramostim, Flow Cytometry, Biopsy. Cryosurgery
n=6 Participants
Sargramostim-250 μg, inhaled, two times a day, on days 4-10 and days 36-42 Flow cytometry-Days 1 \& 32 Immunoenzyme technique-Days 1 \& 32 CT guided biopsy-Days 1 \& 32 Cryosurgery-Days 1 and 32
sargramostim: 250 μg, inhaled, two times a day, on days 4-10 and days 36-42
flow cytometry: Days 1 \& 32
immunoenzyme technique: Days 1 \& 32
biopsy: CT guided biopsy on days 1 \& 32
cryosurgery: Days 1 and 32
|
|---|---|
|
Immune Function and Cancer-specific Response
increase of IFN gamma secreting T cells
|
4 Participants
|
|
Immune Function and Cancer-specific Response
elevated antibody levels
|
4 Participants
|
|
Immune Function and Cancer-specific Response
Increased anti-RC-2+KCI-18 serum antibodies
|
4 Participants
|
Adverse Events
Sargramostim, Flow Cytometry, Biopsy. Cryosurgery
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sargramostim, Flow Cytometry, Biopsy. Cryosurgery
n=8 participants at risk
Sargramostim-250 μg, inhaled, two times a day, on days 4-10 and days 36-42 Flow cytometry-Days 1 \& 32 Immunoenzyme technique-Days 1 \& 32 CT guided biopsy-Days 1 \& 32 Cryosurgery-Days 1 and 32
sargramostim: 250 μg, inhaled, two times a day, on days 4-10 and days 36-42
flow cytometry: Days 1 \& 32
immunoenzyme technique: Days 1 \& 32
biopsy: CT guided biopsy on days 1 \& 32
cryosurgery: Days 1 and 32
|
|---|---|
|
Immune system disorders
Allergic Reaction
|
12.5%
1/8 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
25.0%
2/8 • Number of events 2
|
|
Blood and lymphatic system disorders
Anemia
|
12.5%
1/8 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
12.5%
1/8 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
12.5%
1/8 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm, wheezing
|
12.5%
1/8 • Number of events 1
|
|
General disorders
Chest Pain (noncardiac, nonpleuritic)
|
12.5%
1/8 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Chest Wall Pain
|
75.0%
6/8 • Number of events 12
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
87.5%
7/8 • Number of events 12
|
|
Blood and lymphatic system disorders
Decreased Platelets ( thrombocytopenia)
|
12.5%
1/8 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
12.5%
1/8 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
50.0%
4/8 • Number of events 5
|
|
General disorders
Fatigue
|
50.0%
4/8 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
12.5%
1/8 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary lung (hemoptysis)
|
50.0%
4/8 • Number of events 5
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
12.5%
1/8 • Number of events 1
|
|
General disorders
Low grade fever
|
12.5%
1/8 • Number of events 1
|
|
Investigations
Lymphopenia (low lever of lymphocytes)
|
25.0%
2/8 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • Number of events 1
|
|
General disorders
Pain at incision site
|
12.5%
1/8 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pain - Upper Respiratory throat
|
25.0%
2/8 • Number of events 2
|
|
Investigations
Platelets (low count, thrombocytopenia)
|
25.0%
2/8 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
50.0%
4/8 • Number of events 6
|
|
Nervous system disorders
Sensory Neuropathy
|
12.5%
1/8 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
12.5%
1/8 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Sweating
|
12.5%
1/8 • Number of events 1
|
Additional Information
Peter Littrup, M.D.
Barbara Ann Karmanos Cancer Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place