Interferon Alfa With or Without Thalidomide in Treating Patients With Metastatic Kidney Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. It is not yet known if interferon alfa is more effective with or without thalidomide in treating metastatic kidney cancer.

PURPOSE: Randomized phase II trial to compare the effectiveness of interferon alfa with or without thalidomide in treating patients who have metastatic kidney cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cancer Research UK
• Treatments: Interferon-alpha; Interferons; Thalidomide

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