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

Kidney Cancer Clinical Trial

Official title:

Interferon Alpha In Combination With Thalidomide In The Treatment Of Metastatic Renal Cell Carcinoma A Randomized Phase II Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00027664
• Other study ID #: ICRF-C00.204
• Secondary ID: CDR0000069055EU-
• Status: Active, not recruiting
• Phase: Phase 2
• First received: December 7, 2001
• Last updated: August 6, 2013
• Start date: February 2001

Study information

• Verified date: March 2002
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms

Intervention

Biological:
• recombinant interferon alfa

Drug:
• thalidomide

Locations

Country	Name	City	State
United Kingdom	Beatson West of Scotland Cancer Centre	Glasgow	Scotland
United Kingdom	Leeds Cancer Centre at St. James's University Hospital	Leeds	England
United Kingdom	Oxford Radcliffe Hospital	Oxford	England

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Research UK

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety			Yes
Primary	Toxicity			Yes
Primary	Response rate			No
Primary	Anti-angiogenic effect			No
Primary	Quality of life			No