Clinical trial · Interventional
Trial of Outpatient Intravenous Interleukin-2 in Malignant Melanoma and Metastatic Kidney Cancer
Phase II Trial of Outpatient Intravenous Interleukin-2 in Malignant Melanoma and Metastatic Kidney Cancer
NCT01355562CI-TRIAL-00044905withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Primary Investigator is no longer employed at LLU as of 02/29/12.
Summary
Brief summary (as posted)
The current study will test single agent IL-2 in stage IV melanoma and kidney cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Metastatic Kidney Cancer | Malignant Kidney Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Interleukin-2 (IL-2) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Response rate
- timeFrame
- 9 weeks
Secondary outcomes (1)
- measure
- how long the tumor shrinkage lasts
- timeFrame
- 9 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.