Treatment of Patients With Metastatic Renal Cell Carcinoma Who Have Failed Low Dose Intensity Interleukin-2 With High-Dose Intravenous Recombinant Interleukin-2
18 Years
N/A
Both
Kidney Cancer
Trial Information
Treatment of Patients With Metastatic Renal Cell Carcinoma Who Have Failed Low Dose Intensity Interleukin-2 With High-Dose Intravenous Recombinant Interleukin-2
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) when treated with high-dose intravenous IL-2.
- Determine the overall survival, disease-free survival, and time to progression in
patients treated with this drug.
- Determine the toxicity of this drug in these patients.
OUTLINE: This is a pilot study.
Patients receive high-dose interleukin-2 IV every 8 hours for 15 doses followed 7-10 days
later by another 15 doses (course 1).
Patients are assesed for response 2 months after initiation of treatment. Patients with
responding or stable disease receive a second course of therapy. Patients with an ongoing
response receive subsequent courses of treatment in the absence of unacceptable toxicity.
Patients are followed every 6 months for survival.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Richard L. White, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Blumenthal Cancer Center at Carolinas Medical Center
Authority:
United States: Federal Government
Study ID:
CDR0000357581
NCT ID:
NCT00080977
Start Date:
June 1998
Completion Date:
Related Keywords:
- Kidney Cancer
- recurrent renal cell cancer
- stage IV renal cell cancer
- Carcinoma
- Carcinoma, Renal Cell
- Kidney Neoplasms
Name | Location |
|---|---|
| Blumenthal Cancer Center at Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
