Clinical trial · Interventional
Interleukin-2 in Metastatic Kidney Cancer
Phase II Trial of Moderate Dose Bolus Interleukin-2 in Metastatic Kidney Cancer
NCT01702909CI-TRIAL-00031609terminatedPhase 2Results postedClinicalTrials.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): PI Decision
Summary
Brief summary (as posted)
The purpose of this study is to determine whether Interleukin-2 at the dose and schedule used in this study will help increase tumor shrinkage.
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 |
|---|---|---|---|
| Kidney Cancer Metastatic | — | UNRESOLVED | — |
| Renal Cell Cancer Metastatic | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Interleukin-2 | Drug | Aldesleukin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Interleukin-2
- description
- Interleukin-2
- interventionNames
- Drug: Interleukin-2
Primary outcomes (1)
- measure
- Number of Participants With Response Using RECIST Criteria
- timeFrame
- Measured until Disease Progression or death from any cause up to 2 year
- description
- Radiographic studies to evaluate for response were done after every 2 cycles (6 weeks) until disease progression or death from any cause up to 2 years. Standard RECIST response criteria were utilized. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response Rate (ORR) = 100%(CR + PR/total number of patients receiving Interleukin-2).
Secondary outcomes (2)
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. Patients may have received prior systemic therapy or may be previously untreated 2. Patients must have bi-dimensional 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 \< 3 x upper limit of normal; serum creatinine \< 2.0 mg/dl. 5. Patients must undergo a low-level cardiac stress test as a screen 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. 8. Patient consent must be obtained prior to entrance onto study. 9. Women of childbearing potential must have a negative pregnancy test and must take adequate precautions to prevent pregnancy during treatment 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.