TREATMENT OF METASTATIC RENAL CELL CARCINOMA WITH SUBCUTANEOUS RECOMBINANT INTERLEUKIN-2 AND INTERFERON ALPHA
18 Years
N/A
Both
Kidney Cancer
Trial Information
TREATMENT OF METASTATIC RENAL CELL CARCINOMA WITH SUBCUTANEOUS RECOMBINANT INTERLEUKIN-2 AND INTERFERON ALPHA
OBJECTIVES:
- Evaluate the response and disease-free survival of patients with metastatic renal cell
carcinoma treated with subcutaneous interleukin-2 and interferon alfa.
- Assess the toxicity of this regimen.
OUTLINE: Patients undergo nephrectomy if the diseased kidney makes up the bulk of the tumor
burden.
All patients receive subcutaneous interferon alfa on day 1 and interleukin-2 on days 3-5 of
week 1, followed by reduced doses of interferon alfa and interleukin-2 on days 1, 3, and 5
of weeks 2-6. Patients are assessed for response approximately 2 months after initiating
therapy. Patients with stable or responding disease undergo a second course; those who
continue to respond may receive additional therapy provided toxicity is limited.
Patients are followed for survival.
PROJECTED ACCRUAL: 14 patients will be entered.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically proven renal cell cancer that is metastatic
- No greater than 50% estimated hepatic replacement by tumor on CT or MRI
- No symptomatic involvement of the CNS or a major nerve
- Measurable disease required
- Ineligible for treatment with low-dose interleukin-2 on another CMC protocol
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 50%-100%
Life expectancy:
- More than 3 months
Hematopoietic:
- No coagulopathy (i.e., platelet count less than 80,000/mm3)
Hepatic:
- AST and ALT no greater than 5 times normal
Renal:
- Creatinine less than 4.0 mg/dL
Cardiovascular:
- No symptomatic angina
- No untreated coronary artery disease
- No refractory arrhythmia
- No abnormal left ventricular function
Pulmonary:
- No dyspnea on minimal exertion
Other:
- No site of ongoing bleeding
- No systemic infection
- No HIV antibody
- No HBsAg
- No requirement for steroids
- No psychiatric disease that precludes informed consent or protocol treatment
- No second malignancy except:
- Basal cell skin carcinoma
- Carcinoma in situ of the cervix
- Not pregnant or nursing
- Effective contraception required of fertile women
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior interleukin-2
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- At least 28 days since prior treatment for renal cell cancer
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:
CDR0000065086
NCT ID:
NCT00002847
Start Date:
September 1995
Completion Date:
Related Keywords:
- Kidney Cancer
- stage IV renal cell cancer
- recurrent renal cell cancer
- Carcinoma, Renal Cell
- Kidney Neoplasms
Name | Location |
|---|---|
| Blumenthal Cancer Center at Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
