Interferon Alfa-2b With or Without Thalidomide in Treating Patients With Metastatic or Unresectable Kidney Cancer
Kidney Cancer
About this trial
This is an interventional treatment trial for Kidney Cancer focused on measuring stage III renal cell cancer, stage IV renal cell cancer
Eligibility 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
Sites / Locations
- CCOP - Mayo Clinic Scottsdale Oncology Program
- CCOP - Northern Indiana CR Consortium
- John Stoddard Cancer Center at Iowa Methodist Medical Center
- Mercy Cancer Center at Mercy Medical Center-Des Moines
- Iowa Lutheran Hospital
- Midlands Cancer Center at Midlands Community Hospital
- Cancer Institute of New Jersey
- MBCCOP - University of New Mexico HSC
- Comprehensive Cancer Center at Our Lady of Mercy Medical Center
- Penn State Cancer Institute at Milton S. Hershey Medical Center
- CCOP - St. Vincent Hospital Cancer Center, Green Bay
- Westmead Hospital
- Instituto de Enfermedades Neoplasicas
- San Juan City Hospital