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| Sponsor: | Memorial Sloan-Kettering Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00045279 |
Purpose
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 |
Biological: 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.
Eligibility| 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
Contacts and Locations| 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 |
More Information
| Study ID Numbers: | CDR0000256464, MSKCC-01143, NCI-G-02-2102 |
| Study First Received: | September 6, 2002 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00045279 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV renal cell cancer |
|
Anti-Infective Agents Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Urogenital Neoplasms Urologic Neoplasms Neoplasms by Site Urologic Diseases Kidney Neoplasms Therapeutic Uses Growth Inhibitors Kidney Diseases Angiogenesis Modulating Agents Interferon-alpha |
Neoplasms by Histologic Type Growth Substances Interferons Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Carcinoma Neoplasms Carcinoma, Renal Cell Peginterferon alfa-2b Adenocarcinoma Interferon Alfa-2a Interferon Alfa-2b Neoplasms, Glandular and Epithelial |