Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	Over 18	Other	ICRF-C00.204 EU-20129, NCT00027664

Objectives

1. Determine the safety of interferon alfa and thalidomide in patients with metastatic renal cell carcinoma.
2. Compare the relative toxicity of interferon alfa with or without thalidomide in these patients.
3. Assess the antiangiogenic effect of thalidomide by monitoring the angiogenesis-associated factors in these patients.
4. Compare, in a preliminary manner, the efficacy of interferon alfa with or without thalidomide in these patients.
5. Compare the quality of life of patients treated with these regimens.

Entry Criteria

Disease Characteristics:

• Histologically confirmed metastatic renal cell carcinoma
• Measurable progressive disease, defined as non-irradiated marker lesions greater than 1 cm

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

Patient Characteristics:

Age:

• Over 18

Performance status:

• WHO 0-2

Life expectancy:

• More than 12 weeks

Hematopoietic:

• Neutrophil count greater than 1,500/mm³
• Platelet count greater than 100,000/mm³
• 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

Expected Enrollment

A total of 90 patients will be accrued for this study.

Outcomes

Safety
Toxicity
Response rate
Anti-angiogenic effect
Quality of life

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.

Trial Contact Information

Trial Lead Organizations

Cancer Research UK

Adrian Harris, MD, Protocol chair		Ph: 44-1865-226-184

Registry Information
Official Title		Interferon Alpha In Combination With Thalidomide In The Treatment Of Metastatic Renal Cell Carcinoma A Randomized Phase II Study
Trial Start Date		2001-02-01
Registered in ClinicalTrials.gov		NCT00027664
Date Submitted to PDQ		2001-10-05
Information Last Verified		2002-03-07

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