Melanoma, Metastatic Kidney Cancer
Conditions
Brief summary
The current study will test single agent IL-2 in stage IV melanoma and kidney cancer.
Detailed description
The current study will test single agent IL-2 given daily for 4 doses every 3 weeks for a total of 12 doses in an outpatient setting in stage IV melanoma and kidney cancer to attempt to determine the response rate, how long the responses last, and median survival of this regimen in these two diseases. Responding patients and those with absence of disease progression may receive additional cycles of therapy every 3 weeks.
Interventions
Daily for 4 doses every 3 weeks for a total of 12 doses in an outpatient setting
Sponsors
Loma Linda University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients must have a histologic diagnosis of metastatic kidney cancer or malignant melanoma Patients may be either newly diagnosed with metastatic disease or may have received prior treatment for metastatic kidney cancer. 2. Patients must have measurable disease on physical exam or radiologic studies. 3. ECOG performance status of 0 or 1 and estimated survival of at least 3 months. 4. White blood count of \> 3500/mm3, platelet count \> 100,000/mm3, hemoglobin \> 9.0 gm/dl; bilirubin, ALT, AST \< 2 x upper limit of normal; serum creatinine \< 2.0 mg/dl. 5. Patients must undergo a low-level cardiac stress test (or similar cardiac evaluation such as dobutamine stress echocardiogram or radionuclide-based stress test) for possible atherosclerotic heart disease. Patients with a positive stress test would be excluded from this trial. 6. Patients with elevated temperatures \> 100.5 F must have sources of occult infection excluded. 7. Patients must be felt to have recovered from effects of prior therapy, such as \> 2 weeks after prior chemotherapy.
Exclusion criteria
1. Medical illness requiring corticosteroids or other immunosuppressive agents (such as cyclosporin or methotrexate). 2. Autoimmune disease such as inflammatory arthritis, which could be exacerbated by immune-based therapy. 3. Prior history of psychiatric disorder, which could be exacerbated by interleukin-2. 4. Lactation or pregnancy. 5. Evidence of significant cardiovascular disease including history of recent (\< 6 months prior) myocardial infarction, congestive heart failure, primary cardiac arrhythmias (not due to electrolyte disorder or drug toxicity, for example) beyond occasional PVC's, angina, positive low-level stress test, or cerebrovascular accident. 6. Current brain metastasis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | 9 weeks |
Secondary
| Measure | Time frame |
|---|---|
| how long the tumor shrinkage lasts | 9 weeks |
Countries
United States
Outcome results
None listed