Phase III Randomized Trial of Interferon-Alfa2b Alone Versus Interferon-Alfa2b Plus Thalidomide in Patients With Previously Untreated Metastatic or Unresectable Renal Cell Carcinoma

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically proven previously untreated metastatic or unresectable renal cell
carcinoma

- Retroperitoneal lymph nodes that are unresectable or those that are not resected
at the investigator's discretion are considered metastatic disease

- Prior nephrectomy allowed provided there is evidence of unresponsive metastatic
disease after surgery or within one month prior to study enrollment

- Bidimensionally measurable disease

- Measurable disease must be outside any prior radiotherapy port

- No history of brain metastases unless surgically resected or treated with gamma knife
radiotherapy and currently without radiologic evidence of CNS disease

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Absolute neutrophil count at least 1,500/mm^3

- Hemoglobin at least 9 g/dL (transfusion allowed)

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin no greater than 1.5 mg/dL

- SGOT no greater than 3 times upper limit of normal

Renal:

- Creatinine no greater than 1.5 mg/dL OR

- Creatinine clearance at least 60 mL/min

Cardiovascular:

- No myocardial infarction within the past 6 months

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use 2 effective methods of contraception (1 highly active
method and 1 barrier method) for at least 4 weeks before, during, and for at least 4
weeks after study participation

- No other malignancy within the past 5 years except curatively treated basal cell or
squamous cell skin cancer or carcinoma in situ of the cervix

- No uncontrolled diabetes or any other concurrent illnesses that would increase risk

- No history of peripheral neuropathy

- No severe depression

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior immunotherapy (including adjuvant interferon alfa therapy), cellular
therapy, or vaccine therapy for renal cell carcinoma

- No prior antiangiogenesis therapy for renal cell carcinoma

- Immunotherapy for prior malignancy allowed (except for interferon alfa therapy)

Chemotherapy:

- No prior chemotherapy for renal cell carcinoma

- Chemotherapy for prior malignancy allowed

Endocrine therapy:

- No prior hormonal therapy for renal cell carcinoma

Radiotherapy:

- See Disease Characteristics

- At least 2 weeks since prior radiotherapy and recovered

Surgery:

- See Disease Characteristics

Other:

- More than 7 days since prior IV antibiotics for infection