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Sponsors and Collaborators: |
Barbara Ann Karmanos Cancer Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00238329 |
RATIONALE: PEG-interferon alfa-2b may interfere with the growth of tumor cells. Biological therapies, such as thalidomide, may stimulate the immune system in different ways and stop tumor cells from growing. PEG-interferon alfa-2b and thalidomide may also stop the growth of melanoma by blocking blood flow to the tumor. Giving PEG-interferon alfa-2b together with thalidomide may be an effective treatment for melanoma.
PURPOSE: This phase II trial is studying how well giving PEG-interferon alfa-2b together with thalidomide works in treating patients with recurrent or metastatic melanoma.
Condition | Intervention | Phase |
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Intraocular Melanoma Melanoma (Skin) |
Biological: PEG-interferon alfa-2b Drug: thalidomide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Study of Pegylated Interferon and Thalidomide in Pretreated Metastatic Malignant Melanoma |
Estimated Enrollment: | 32 |
Study Start Date: | January 2001 |
OBJECTIVES:
OUTLINE: Patients receive PEG-interferon alfa-2b subcutaneously once weekly and oral thalidomide once daily.
Treatment continues for at least 2 weeks but no more than 8 months in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive PEG-interferon alfa-2b and thalidomide for 2 months beyond documentation of CR.
PROJECTED ACCRUAL: A total of 18-32 patients will be accrued for this study within 14-38 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed malignant melanoma, including any of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
None of the following conditions within the past 3 months:
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Michigan | |
Barbara Ann Karmanos Cancer Institute | |
Detroit, Michigan, United States, 48201-1379 |
Principal Investigator: | Ulka N. Vaishampayan, MD | Barbara Ann Karmanos Cancer Institute |
Study ID Numbers: | CDR0000445593, WSU-C-2257, WSU-HIC-120900M01-FB |
Study First Received: | October 12, 2005 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00238329 History of Changes |
Health Authority: | United States: Federal Government |
recurrent melanoma stage IV melanoma ciliary body and choroid melanoma, medium/large size |
extraocular extension melanoma iris melanoma recurrent intraocular melanoma |
Anti-Infective Agents Uveal Melanoma Thalidomide Immunologic Factors Melanoma of the Choroid Melanoma Anti-Bacterial Agents Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma Interferon-alpha Eye Neoplasms Eye Diseases |
Interferons Antiviral Agents Angiogenesis Inhibitors Immunosuppressive Agents Recurrence Neuroendocrine Tumors Neuroectodermal Tumors Intraocular Melanoma Peginterferon alfa-2b Nevus Interferon Alfa-2a Interferon Alfa-2b |
Anti-Infective Agents Thalidomide Immunologic Factors Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Melanoma Anti-Bacterial Agents Neoplasms by Site Neoplasms, Germ Cell and Embryonal Therapeutic Uses Nevi and Melanomas Growth Inhibitors Angiogenesis Modulating Agents Interferon-alpha |
Neoplasms by Histologic Type Eye Neoplasms Growth Substances Eye Diseases Interferons Immunosuppressive Agents Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms Peginterferon alfa-2b Interferon Alfa-2a Interferon Alfa-2b |