Interferon Alfa With or Without Thalidomide in Treating Patients With Metastatic Kidney Cancer
NCT ID: NCT00027664
Last Updated: 2013-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
90 participants
INTERVENTIONAL
2001-02-28
Brief Summary
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PURPOSE: Randomized phase II trial to compare the effectiveness of interferon alfa with or without thalidomide in treating patients who have metastatic kidney cancer.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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recombinant interferon alfa
thalidomide
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Cancer Research UK
OTHER
Principal Investigators
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Adrian L. Harris, MD
Role: STUDY_CHAIR
Oxford University Hospitals NHS Trust
Locations
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Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom
Oxford Radcliffe Hospital
Oxford, England, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, Scotland, United Kingdom
Countries
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Other Identifiers
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CDR0000069055
Identifier Type: REGISTRY
Identifier Source: secondary_id
EU-20129
Identifier Type: -
Identifier Source: secondary_id
ICRF-C00.204
Identifier Type: -
Identifier Source: org_study_id