Interferon Alpha In Combination With Thalidomide In The Treatment Of Metastatic Renal Cell Carcinoma A Randomized Phase II Study
18 Years
N/A
Both
Kidney Cancer
Trial Information
Interferon Alpha In Combination With Thalidomide In The Treatment Of Metastatic Renal Cell Carcinoma A Randomized Phase II Study
OBJECTIVES:
- Determine the safety of interferon alfa and thalidomide in patients with metastatic
renal cell carcinoma.
- Compare the relative toxicity of interferon alfa with or without thalidomide in these
patients.
- Assess the antiangiogenic effect of thalidomide by monitoring the
angiogenesis-associated factors in these patients.
- Compare, in a preliminary manner, the efficacy of interferon alfa with or without
thalidomide in these patients.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two
treatment arms.
- Arm I: Patients receive interferon alfa subcutaneously 3 times a week and oral
thalidomide once daily for 12 weeks.
- Arm II: Patients receive interferon alfa only as in arm I. Treatment in both arms
repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
Patients in arm II who develop disease progression discontinue interferon alfa and
receive thalidomide only as in arm I.
Quality of life is assessed at baseline and then every 3 weeks during each study course.
PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed metastatic renal cell carcinoma
- Measurable progressive disease, defined as non-irradiated marker lesions greater than
1 cm
PATIENT CHARACTERISTICS:
Age:
- Over 18
Performance status:
- WHO 0-2
Life expectancy:
- More than 12 weeks
Hematopoietic:
- Neutrophil count greater than 1,500/mm^3
- Platelet count greater than 100,000/mm^3
- Hemoglobin greater than 10 g/dL
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- AST/ALT less than 5 times ULN
Renal:
- Creatinine clearance greater than 50 mL/min OR
- Edetic acid clearance greater than 40 mL/min
Cardiovascular:
- No unstable angina or myocardial infarction within the past 6 months
Other:
- No other prior invasive malignancy except cervical intraepithelial neoplasia or
nonmelanomatous skin cancer
- No chronic neurological disease causing peripheral neuropathy
- No diabetes mellitus
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use at least one highly effective method and at least one
additional effective method of contraception for female patients and barrier
contraception for male patients for at least 2 weeks before and during study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior interferon alfa for metastatic renal cell carcinoma
Chemotherapy:
- No prior systemic chemotherapy for metastatic renal cell carcinoma
- No concurrent cytotoxic therapy
Endocrine therapy:
- No concurrent corticosteroids
Radiotherapy:
- See Disease Characteristics
- Concurrent local radiotherapy for symptomatic secondary sites of disease allowed if
these sites are not being used as markers of disease response
Surgery:
- Not specified
Other:
- No other prior systemic treatment for metastatic renal cell carcinoma
- No concurrent chronic medication known to cause peripheral neuropathy
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Safety
Safety Issue:
Yes
Principal Investigator
Adrian L. Harris, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Oxford Radcliffe Hospital
Authority:
United States: Federal Government
Study ID:
CDR0000069055
NCT ID:
NCT00027664
Start Date:
February 2001
Completion Date:
Related Keywords:
- Kidney Cancer
- stage IV renal cell cancer
- Carcinoma, Renal Cell
- Kidney Neoplasms
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