Trial Outcomes & Findings for Chemotherapy, Irradiation, Cell Infusions, and Interleukin-2 to Treat Metastatic Melanoma (NCT NCT00314106)
NCT ID: NCT00314106
Last Updated: 2012-10-18
Results Overview
Determine if the combination of high dose aldesleukin, reinfused cells after lymphocyte depleting chemotherapy and 1200 cGy total body irradiation (TBI) is able to be associated with a modest fraction of patients with metastatic melanoma who can experience a complete response to therapy. Complete response (CR) is a disappearance of all target lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
26 participants
Primary outcome timeframe
33 months
Results posted on
2012-10-18
Participant Flow
Participant milestones
| Measure |
TBI 1200 cGy + TIL +HD IL-2, Prior IL-2
Patients that received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m\^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses).
|
TBI 1200 cGy + TIL +HD IL-2, no Prior IL-2
Patients that have not received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m\^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses)
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
8
|
|
Overall Study
COMPLETED
|
18
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Chemotherapy, Irradiation, Cell Infusions, and Interleukin-2 to Treat Metastatic Melanoma
Baseline characteristics by cohort
| Measure |
TBI 1200 cGy + TIL +HD IL-2, Prior IL-2
n=18 Participants
Patients that received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m\^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses).
|
TBI 1200 cGy + TIL +HD IL-2, no Prior IL-2
n=8 Participants
Patients that have not received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m\^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses)
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
26 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
|
43.4 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
48.5 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
44.7 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
26 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
8 participants
n=7 Participants
|
26 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 33 monthsDetermine if the combination of high dose aldesleukin, reinfused cells after lymphocyte depleting chemotherapy and 1200 cGy total body irradiation (TBI) is able to be associated with a modest fraction of patients with metastatic melanoma who can experience a complete response to therapy. Complete response (CR) is a disappearance of all target lesions.
Outcome measures
| Measure |
TBI 1200 cGy + TIL +HD IL-2, Prior IL-2
n=18 Participants
Patients that received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m\^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses).
|
TBI 1200 cGy + TIL +HD IL-2, no Prior IL-2
n=8 Participants
Patients that have not received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m\^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses)
|
|---|---|---|
|
Complete Response
|
7 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 33 monthsHere is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.
Outcome measures
| Measure |
TBI 1200 cGy + TIL +HD IL-2, Prior IL-2
n=18 Participants
Patients that received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m\^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses).
|
TBI 1200 cGy + TIL +HD IL-2, no Prior IL-2
n=8 Participants
Patients that have not received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m\^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses)
|
|---|---|---|
|
Number of Participants With Adverse Events
|
18 Participants
|
8 Participants
|
Adverse Events
TBI 1200 cGy + TIL +HD IL-2, Prior IL-2
Serious events: 7 serious events
Other events: 18 other events
Deaths: 0 deaths
TBI 1200 cGy + TIL +HD IL-2, no Prior IL-2
Serious events: 4 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TBI 1200 cGy + TIL +HD IL-2, Prior IL-2
n=18 participants at risk
Patients that received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m\^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses).
|
TBI 1200 cGy + TIL +HD IL-2, no Prior IL-2
n=8 participants at risk
Patients that have not received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m\^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses)
|
|---|---|---|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
11.1%
2/18 • Number of events 2
|
25.0%
2/8 • Number of events 2
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
11.1%
2/18 • Number of events 2
|
25.0%
2/8 • Number of events 2
|
|
Immune system disorders
Autoimmune disorder
|
5.6%
1/18 • Number of events 1
|
0.00%
0/8
|
|
Immune system disorders
Hypersensitivity
|
5.6%
1/18 • Number of events 1
|
0.00%
0/8
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
11.1%
2/18 • Number of events 2
|
0.00%
0/8
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
5.6%
1/18 • Number of events 1
|
0.00%
0/8
|
|
Cardiac disorders
left ventricular dysfunction
|
5.6%
1/18 • Number of events 1
|
0.00%
0/8
|
|
General disorders
Weight loss
|
11.1%
2/18 • Number of events 2
|
0.00%
0/8
|
|
Gastrointestinal disorders
Anorexia
|
16.7%
3/18 • Number of events 3
|
0.00%
0/8
|
|
Infections and infestations
Sepsis
|
5.6%
1/18 • Number of events 1
|
0.00%
0/8
|
|
Infections and infestations
Urinary tract infection
|
5.6%
1/18 • Number of events 2
|
0.00%
0/8
|
|
Infections and infestations
peripheral nerve infection
|
11.1%
2/18 • Number of events 2
|
0.00%
0/8
|
|
Metabolism and nutrition disorders
Bilirubin increased
|
5.6%
1/18 • Number of events 1
|
0.00%
0/8
|
|
Metabolism and nutrition disorders
Creatinine increased
|
5.6%
1/18 • Number of events 1
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
Gait abnormal
|
5.6%
1/18 • Number of events 1
|
0.00%
0/8
|
|
General disorders
Pain in extremity
|
5.6%
1/18 • Number of events 1
|
0.00%
0/8
|
|
Renal and urinary disorders
Renal failure
|
11.1%
2/18 • Number of events 2
|
0.00%
0/8
|
Other adverse events
| Measure |
TBI 1200 cGy + TIL +HD IL-2, Prior IL-2
n=18 participants at risk
Patients that received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m\^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses).
|
TBI 1200 cGy + TIL +HD IL-2, no Prior IL-2
n=8 participants at risk
Patients that have not received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m\^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses)
|
|---|---|---|
|
Immune system disorders
Autoimmune disorder
|
11.1%
2/18 • Number of events 2
|
0.00%
0/8
|
|
Ear and labyrinth disorders
Tinnitus
|
11.1%
2/18 • Number of events 2
|
0.00%
0/8
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
55.6%
10/18 • Number of events 13
|
62.5%
5/8 • Number of events 7
|
|
Blood and lymphatic system disorders
Leukocyte count decreased
|
94.4%
17/18 • Number of events 20
|
100.0%
8/8 • Number of events 10
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
100.0%
18/18 • Number of events 27
|
100.0%
8/8 • Number of events 12
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
94.4%
17/18 • Number of events 18
|
100.0%
8/8 • Number of events 11
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
88.9%
16/18 • Number of events 17
|
100.0%
8/8 • Number of events 8
|
|
Cardiac disorders
Hypotension
|
11.1%
2/18 • Number of events 2
|
0.00%
0/8
|
|
Blood and lymphatic system disorders
Activated partial thromboplastin time prolonged
|
16.7%
3/18 • Number of events 3
|
25.0%
2/8 • Number of events 2
|
|
General disorders
Fatigue
|
55.6%
10/18 • Number of events 13
|
12.5%
1/8 • Number of events 1
|
|
General disorders
Fever
|
22.2%
4/18 • Number of events 4
|
0.00%
0/8
|
|
General disorders
Insomnia
|
11.1%
2/18 • Number of events 2
|
0.00%
0/8
|
|
Gastrointestinal disorders
Weight loss
|
27.8%
5/18 • Number of events 5
|
75.0%
6/8 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
11.1%
2/18 • Number of events 2
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
22.2%
4/18 • Number of events 4
|
12.5%
1/8 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
44.4%
8/18 • Number of events 8
|
25.0%
2/8 • Number of events 2
|
|
Gastrointestinal disorders
Anorexia
|
11.1%
2/18 • Number of events 2
|
0.00%
0/8
|
|
Gastrointestinal disorders
Ascites
|
5.6%
1/18 • Number of events 1
|
0.00%
0/8
|
|
Gastrointestinal disorders
Dehydration
|
11.1%
2/18 • Number of events 2
|
12.5%
1/8 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
61.1%
11/18 • Number of events 11
|
50.0%
4/8 • Number of events 4
|
|
Gastrointestinal disorders
Nausea
|
66.7%
12/18 • Number of events 13
|
25.0%
2/8 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
44.4%
8/18 • Number of events 8
|
0.00%
0/8
|
|
Infections and infestations
Febrile Neutropenia
|
55.6%
10/18 • Number of events 10
|
75.0%
6/8 • Number of events 6
|
|
Infections and infestations
Catheter-related infection
|
11.1%
2/18 • Number of events 2
|
0.00%
0/8
|
|
Infections and infestations
vaginal infection
|
5.6%
1/18 • Number of events 1
|
0.00%
0/8
|
|
Infections and infestations
Pneumonia
|
5.6%
1/18 • Number of events 1
|
0.00%
0/8
|
|
Renal and urinary disorders
Urinary tract infection
|
5.6%
1/18 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
|
Infections and infestations
Infection
|
5.6%
1/18 • Number of events 1
|
0.00%
0/8
|
|
Infections and infestations
Sepsis
|
5.6%
1/18 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
|
Blood and lymphatic system disorders
Edema limbs
|
5.6%
1/18 • Number of events 1
|
0.00%
0/8
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
50.0%
9/18 • Number of events 10
|
62.5%
5/8 • Number of events 5
|
|
Metabolism and nutrition disorders
Alkaline phosphatase increased
|
5.6%
1/18 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
|
Metabolism and nutrition disorders
Alanine aminotransferase increased
|
11.1%
2/18 • Number of events 2
|
0.00%
0/8
|
|
Metabolism and nutrition disorders
Aspartate aminotransferase increased
|
11.1%
2/18 • Number of events 2
|
0.00%
0/8
|
|
Metabolism and nutrition disorders
Bilirubin increased
|
11.1%
2/18 • Number of events 2
|
12.5%
1/8 • Number of events 1
|
|
Metabolism and nutrition disorders
serum calcium decreased
|
38.9%
7/18 • Number of events 7
|
37.5%
3/8 • Number of events 3
|
|
Metabolism and nutrition disorders
Creatinine increased
|
16.7%
3/18 • Number of events 3
|
25.0%
2/8 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum magnesium increased
|
5.6%
1/18 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
33.3%
6/18 • Number of events 10
|
50.0%
4/8 • Number of events 5
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
11.1%
2/18 • Number of events 3
|
37.5%
3/8 • Number of events 3
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
22.2%
4/18 • Number of events 4
|
37.5%
3/8 • Number of events 3
|
|
Metabolism and nutrition disorders
Blood uric acid increased
|
11.1%
2/18 • Number of events 3
|
0.00%
0/8
|
|
Nervous system disorders
Confusion
|
27.8%
5/18 • Number of events 5
|
62.5%
5/8 • Number of events 5
|
|
Nervous system disorders
Euphoria
|
5.6%
1/18 • Number of events 1
|
0.00%
0/8
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.6%
1/18 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
|
Eye disorders
Uveitis
|
5.6%
1/18 • Number of events 1
|
0.00%
0/8
|
|
Eye disorders
Vision blurred
|
5.6%
1/18 • Number of events 1
|
25.0%
2/8 • Number of events 2
|
|
General disorders
Abdominal pain
|
16.7%
3/18 • Number of events 4
|
12.5%
1/8 • Number of events 1
|
|
General disorders
Bone pain
|
11.1%
2/18 • Number of events 2
|
0.00%
0/8
|
|
General disorders
Pain in extremity
|
16.7%
3/18 • Number of events 4
|
0.00%
0/8
|
|
General disorders
joint pain
|
5.6%
1/18 • Number of events 1
|
0.00%
0/8
|
|
General disorders
scrotal pain
|
5.6%
1/18 • Number of events 1
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
5.6%
1/18 • Number of events 1
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
2/18 • Number of events 2
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
3/18 • Number of events 3
|
25.0%
2/8 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.6%
1/18 • Number of events 1
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.6%
1/18 • Number of events 1
|
0.00%
0/8
|
|
Vascular disorders
Capillary leak syndrome
|
22.2%
4/18 • Number of events 4
|
50.0%
4/8 • Number of events 4
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/18
|
25.0%
2/8 • Number of events 2
|
|
Blood and lymphatic system disorders
Petechiae
|
0.00%
0/18
|
25.0%
2/8 • Number of events 2
|
|
Infections and infestations
Upper aerodigestive tract infection
|
0.00%
0/18
|
12.5%
1/8 • Number of events 1
|
|
Nervous system disorders
Facial nerve disorder
|
0.00%
0/18
|
12.5%
1/8 • Number of events 1
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/18
|
12.5%
1/8 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/18
|
12.5%
1/8 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
0.00%
0/18
|
12.5%
1/8 • Number of events 1
|
Additional Information
Steven A. Rosenberg, M.D.
National Cancer Institute, National Institutes of Health
Phone: 301-496-4164
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place