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Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00026520 |
RATIONALE: Interferon alfa may interfere with the growth of cancer cells and slow the growth of the tumor. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining interferon alfa with thalidomide may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining interferon alfa with thalidomide in treating patients who have stage IV melanoma.
Condition | Intervention | Phase |
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Melanoma (Skin) |
Drug: recombinant interferon alfa Drug: thalidomide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Evaluation of Interferon Alpha-2b and Thalidomide in Patients With Disseminated Malignant Melanoma, Phase II |
Study Start Date: | November 2001 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive interferon alfa subcutaneously twice daily and oral thalidomide once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 2 additional courses after documentation of CR.
Patients are followed every 3 months for 2 years and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 35 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 stage IV malignant melanoma
No brain metastases by CT scan or MRI
Must have received 1, and only 1, prior systemic therapy for metastatic disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Study Chair: | Laura F. Hutchins, MD | University of Arkansas |
Study ID Numbers: | CDR0000069046, SWOG-S0026 |
Study First Received: | November 9, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00026520 |
Health Authority: | United States: Federal Government |
stage IV melanoma recurrent melanoma |
Interferon-alpha Interferon Type I, Recombinant Thalidomide Interferons Recurrence Melanoma Neuroendocrine Tumors |
Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Neuroepithelioma Nevus Interferon Alfa-2a Interferon Alfa-2b |
Anti-Infective Agents Neoplasms by Histologic Type Immunologic Factors Antineoplastic Agents Growth Substances Neoplasms, Nerve Tissue Physiological Effects of Drugs Immunosuppressive Agents Antiviral Agents |
Angiogenesis Inhibitors Pharmacologic Actions Anti-Bacterial Agents Neoplasms Therapeutic Uses Nevi and Melanomas Growth Inhibitors Angiogenesis Modulating Agents Leprostatic Agents |