Interferon Alfa With or Without Thalidomide in Treating Patients With Metastatic Kidney Cancer
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Cancer |
Biological: recombinant interferon alfa Drug: thalidomide |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | Interferon Alpha In Combination With Thalidomide In The Treatment Of Metastatic Renal Cell Carcinoma A Randomized Phase II Study |
- Safety [ Designated as safety issue: Yes ]
- Toxicity [ Designated as safety issue: Yes ]
- Response rate [ Designated as safety issue: No ]
- Anti-angiogenic effect [ Designated as safety issue: No ]
- Quality of life [ Designated as safety issue: No ]
| Estimated Enrollment: | 90 |
| Study Start Date: | February 2001 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United Kingdom | |
| Leeds Cancer Centre at St. James's University Hospital | |
| Leeds, England, United Kingdom, LS9 7TF | |
| Oxford Radcliffe Hospital | |
| Oxford, England, United Kingdom, 0X3 9DU | |
| Beatson West of Scotland Cancer Centre | |
| Glasgow, Scotland, United Kingdom, G12 0YN | |
| Study Chair: | Adrian L. Harris, MD | Oxford Radcliffe Hospital |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00027664 History of Changes |
| Other Study ID Numbers: | CDR0000069055, ICRF-C00.204, EU-20129 |
| Study First Received: | December 7, 2001 |
| Last Updated: | October 29, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage IV renal cell cancer |
Additional relevant MeSH terms:
|
Carcinoma, Renal Cell Kidney Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases Interferon-alpha Interferon Alfa-2a Interferons |
Thalidomide Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents Immunosuppressive Agents Leprostatic Agents Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 23, 2013