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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00049530 |
RATIONALE: PEG-interferon alfa-2b may stop the growth of 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 stage IV melanoma.
Condition | Intervention | Phase |
---|---|---|
Melanoma (Skin) |
Biological: PEG-interferon alfa-2b |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Study of Low Dose Peginterferon Alfa-2b in Patients With Metastatic Melanoma Over-Expressing Basic Fibroblast Growth Factor |
Estimated Enrollment: | 32 |
Study Start Date: | September 2003 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study.
PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study within 2 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed stage IV melanoma
CNS involvement allowed provided CNS directed therapy has been given and disease has been clinically stable for ≥ 3 months
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Study Chair: | Ronald S. Go, MD | Gundersen Lutheran Center for Cancer and Blood |
Responsible Party: | ECOG Group Chair's Office ( Robert L. Comis ) |
Study ID Numbers: | CDR0000258114, ECOG-2602 |
Study First Received: | November 12, 2002 |
Last Updated: | May 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00049530 History of Changes |
Health Authority: | Unspecified |
recurrent melanoma stage IV melanoma |
Interferon-alpha Immunologic Factors Interferons Angiogenesis Inhibitors Antiviral Agents Recurrence Melanoma Neuroendocrine Tumors Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Peginterferon alfa-2b Mitogens Neuroepithelioma Nevus Interferon Alfa-2a Interferon Alfa-2b |
Interferon-alpha Anti-Infective Agents Neoplasms by Histologic Type Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Neoplasms, Nerve Tissue Interferons Angiogenesis Inhibitors Antiviral Agents Pharmacologic Actions |
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms Therapeutic Uses Neoplasms, Germ Cell and Embryonal Peginterferon alfa-2b Nevi and Melanomas Growth Inhibitors Angiogenesis Modulating Agents Interferon Alfa-2a Interferon Alfa-2b |