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Sponsored by: |
Medical University of South Carolina |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00090870 |
RATIONALE: PEG-interferon alfa-2b may interfere with the growth of tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining PEG-interferon alfa-2b with sargramostim and thalidomide may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving PEG-interferon alfa-2b together with sargramostim and thalidomide works in treating patients with metastatic kidney cancer.
Condition | Intervention | Phase |
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Kidney Cancer |
Biological: PEG-interferon alfa-2b Biological: sargramostim Drug: thalidomide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study Of Peg-Intron, GM-CSF And Thalidomide In Metastatic Renal Cell Carcinoma |
Estimated Enrollment: | 25 |
Study Start Date: | April 2002 |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive PEG-interferon alfa-2b subcutaneously (SC) on days 1 and 8, sargramostim (GM-CSF) SC on days 1-10, and oral thalidomide once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed renal cell carcinoma
Measurable disease
Unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan or MRI
The following are not considered measurable disease:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
United States, South Carolina | |
Hollings Cancer Center at Medical University of South Carolina | |
Charleston, South Carolina, United States, 29425 |
Study Chair: | Uzair B. Chaudhary, MD | Medical University of South Carolina |
Study ID Numbers: | CDR0000378049, MUSC-100614, CELGENE-MUSC-100614, MUSC-HR-10423 |
Study First Received: | September 7, 2004 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00090870 History of Changes |
Health Authority: | United States: Federal Government |
stage IV renal cell cancer |
Interferon-alpha Urinary Tract Neoplasm Kidney Cancer Immunologic Factors Thalidomide Interferons Urogenital Neoplasms Urologic Neoplasms Immunosuppressive Agents Angiogenesis Inhibitors Antiviral Agents Carcinoma |
Anti-Bacterial Agents Renal Cancer Urologic Diseases Kidney Neoplasms Peginterferon alfa-2b Carcinoma, Renal Cell Kidney Diseases Interferon Alfa-2a Adenocarcinoma Interferon Alfa-2b Neoplasms, Glandular and Epithelial |
Anti-Infective Agents Thalidomide Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Urogenital Neoplasms Urologic Neoplasms Anti-Bacterial Agents Neoplasms by Site Urologic Diseases Kidney Neoplasms Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Kidney Diseases |
Interferon-alpha Neoplasms by Histologic Type Growth Substances Interferons Immunosuppressive Agents Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Carcinoma Neoplasms Carcinoma, Renal Cell Peginterferon alfa-2b Adenocarcinoma Interferon Alfa-2a Interferon Alfa-2b |