Kidney Cancer Clinical Trial
Official title:
Phase III Randomized Trial of Interferon-Alfa2b Alone Versus Interferon-Alfa2b Plus Thalidomide in Patients With Previously Untreated Metastatic or Unresectable Renal Cell Carcinoma
Verified date | September 2002 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
RATIONALE: Interferon alfa-2b may interfere with the growth of the cancer cells. Thalidomide
may stop the growth of cancer by stopping blood flow to the tumor. It is not yet known if
interferon alfa-2b is more effective with or without thalidomide in treating kidney cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa-2b with
or without thalidomide in treating patients who have previously untreated metastatic or
unresectable kidney cancer.
Status | Completed |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | March 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Westmead Hospital | Westmead | New South Wales |
Peru | Instituto de Enfermedades Neoplasicas | Lima | |
Puerto Rico | San Juan City Hospital | San Juan | |
United States | MBCCOP - University of New Mexico HSC | Albuquerque | New Mexico |
United States | Comprehensive Cancer Center at Our Lady of Mercy Medical Center | Bronx | New York |
United States | Iowa Lutheran Hospital | Des Moines | Iowa |
United States | John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines | Iowa |
United States | Mercy Cancer Center at Mercy Medical Center-Des Moines | Des Moines | Iowa |
United States | CCOP - St. Vincent Hospital Cancer Center, Green Bay | Green Bay | Wisconsin |
United States | Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey | Pennsylvania |
United States | Cancer Institute of New Jersey | New Brunswick | New Jersey |
United States | Midlands Cancer Center at Midlands Community Hospital | Papillion | Nebraska |
United States | CCOP - Mayo Clinic Scottsdale Oncology Program | Scottsdale | Arizona |
United States | CCOP - Northern Indiana CR Consortium | South Bend | Indiana |
Lead Sponsor | Collaborator |
---|---|
Eastern Cooperative Oncology Group | National Cancer Institute (NCI) |
United States, Australia, Peru, Puerto Rico,
Gordon MS, Manola J, Fairclough D, et al.: Low dose interferon-a2b (IFN) + thalidomide (T) in patients (pts) with previously untreated renal cell cancer (RCC). Improvement in progression-free survival (PFS) but not quality of life (QoL) or overall surviva
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