Clinical trial · Interventional
High-Dose Intravenous Interleukin-2 in Treating Patients With Metastatic Renal Cell Carcinoma (Kidney Cancer) That Has Not Responded to Previous Low-Dose Intravenous or Subcutaneous Interleukin-2
Treatment of Patients With Metastatic Renal Cell Carcinoma Who Have Failed Low Dose Intensity Interleukin-2 With High-Dose Intravenous Recombinant Interleukin-2
NCT00080977CI-TRIAL-00013165unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill renal cell carcinoma (kidney cancer) cells. PURPOSE: This phase II trial is studying how well high-dose intravenous interleukin-2 works in treating patients with metastatic renal cell carcinoma that has not responded to previous low-dose intravenous or subcutaneous interleukin-2.
Conditions
Conditions (1)
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 | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aldesleukin | Biological | Aldesleukin | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed renal cell carcinoma * Metastatic disease * No pure papillary or sarcomatoid variants * Measurable disease * Failed prior subcutaneous OR intravenous (dose ≤ 50,000 IU/kg/day) interleukin-2 * Documented disease progression * No estimated hepatic replacement by tumor \> 25% by CT scan or MRI * No tumor involving the CNS or a major nerve PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 80-100% Life expectancy * More than 3 months Hematopoietic * Platelet count ≥ 80,000/mm\^3 * No sites of ongoing bleeding Hepatic * See Disease Characteristics * Bilirubin ≤ 1.4 mg/dL * AST and ALT ≤ 3 times normal * PT or PTT INR ≤ 1.2 * Hepatitis B surface antigen negative * Hepatitis C virus negative * No coagulation disorders Renal * Creatinine ≤ 1.6 mg/dL Cardiovascular * No ongoing ischemia\* * No cardiac dysfunction\* * No abnormal ejection fraction\* NOTE: \*A cardiac stress test is indicated for all patients ≥ 50 years of age and for any patient with possible cardiac disease as suggested by history, physical exam, or electrocardiogram Pulmonary * FEV\_1 ≤ 65% of predicted\* * Vital capacity ≤ 65% of predicted\* NOTE: \*Pulmonary function tests are to be performed on any patient with a significant smoking history or suspected pulmonary disease either by history, physical exam, or radiograph Other * HIV negative * No AIDS * No systemic infections * No other malignancy except carcinoma in situ * No psychiatric illness that would preclude study participation or compliance * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics Chemotherapy * Not specified Endocrine therapy * No concurrent steroids Radiotherapy * Not specified Surgery * Not specified Other * More than 28 days since other prior treatment for renal cell cancer * No concurrent immunosuppressive agents
References
Publications (0)
Data not yet available
No reference posted for this study.