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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00045279 |
RATIONALE: PEG-interferon alfa-2b may stop the growth of kidney cancer by stopping blood flow to the tumor.
PURPOSE: Phase II trial to study the effectiveness of PEG-interferon alfa-2b in treating patients who have metastatic kidney cancer.
Condition | Intervention | Phase |
---|---|---|
Kidney Cancer |
Drug: PEG-interferon alfa-2b |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Trial of PEG-Intron in Patients With Advanced Renal Cell Carcinoma |
Study Start Date: | April 2002 |
OBJECTIVES:
OUTLINE: Patients receive PEG-interferon alfa-2b subcutaneously once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, at 2 weeks and at 2, 4, 8, and 12 months after initiation of study therapy, and then at completion of study therapy.
PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study within 15 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed renal cell carcinoma
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
No malignancy within the past 2 years except basal cell or squamous cell skin cancer, superficial bladder cancer, or localized prostate cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 |
Study Chair: | Robert J. Motzer, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000256464, MSKCC-01143, NCI-G-02-2102 |
Study First Received: | September 6, 2002 |
Last Updated: | August 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00045279 |
Health Authority: | United States: Federal Government |
stage IV renal cell cancer |
Interferon-alpha Interferons Urogenital Neoplasms Renal cancer Urologic Neoplasms Kidney cancer Carcinoma Urologic Diseases Kidney Neoplasms |
Peginterferon alfa-2b Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Interferon Alfa-2a Interferon Alfa-2b Urinary tract neoplasm Neoplasms, Glandular and Epithelial |
Anti-Infective Agents Neoplasms by Histologic Type Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Antiviral Agents |
Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors |