Status:
UNKNOWN
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
Lead Sponsor:
Blumenthal Cancer Center at Carolinas Medical Center
Conditions:
Kidney Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 interle...
Detailed Description
OBJECTIVES: * Determine the response rate (complete, partial, and minor) in patients with metastatic renal cell carcinoma who failed prior low-dose intravenous or subcutaneous interleukin-2 (IL-2) wh...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 1998
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00080977
Start Date
June 1 1998
Last Update
December 19 2013
Active Locations (1)
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1
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861