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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005815 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of melanoma by stopping blood flow to the tumor. Combining chemotherapy with thalidomide may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness temozolomide plus thalidomide in treating patients who have stage III or stage IV melanoma that cannot be removed during surgery.
Condition | Intervention | Phase |
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Intraocular Melanoma Melanoma (Skin) |
Drug: temozolomide Drug: thalidomide |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I/II Study of Temozolamide and Thalidomide in the Treatment of Advanced Melanoma |
Study Start Date: | December 1999 |
OBJECTIVES:
OUTLINE: This is a dose escalation study of temozolomide (phase I) followed by a response rate determination study (phase II).
Patients receive oral temozolomide daily for 6 weeks followed by 2-4 weeks of rest. Patients receive oral thalidomide daily for the entire 8-10 week course. Treatment continues in the absence of unacceptable toxicity or disease progression.
Cohorts of 3-6 patients receive escalating doses of temozolomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities. Once the MTD is determined, additional patients are accrued to receive treatment with temozolomide and thalidomide at the recommended phase II dose.
PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for phase I and then an additional 45 patients (15 with CNS disease, 30 without CNS disease) will be accrued for phase II of this study within 18 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed metastatic malignant melanoma that is considered unresectable
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
No other malignancy within the past 2 years except:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 |
Study Chair: | Wen-Jen Hwu, MD, PhD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000067818, MSKCC-99103, NCI-G00-1786 |
Study First Received: | June 2, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00005815 History of Changes |
Health Authority: | United States: Federal Government |
iris melanoma ciliary body and choroid melanoma, small size ciliary body and choroid melanoma, medium/large size extraocular extension melanoma |
recurrent intraocular melanoma stage III melanoma stage IV melanoma recurrent melanoma |
Immunologic Factors Thalidomide Eye Neoplasms Uveal Melanoma Eye Diseases Melanoma of the Choroid Angiogenesis Inhibitors Immunosuppressive Agents Temozolomide Recurrence Melanoma |
Neuroendocrine Tumors Anti-Bacterial Agents Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Intraocular Melanoma Neuroepithelioma Antineoplastic Agents, Alkylating Nevus Alkylating Agents |
Anti-Infective Agents Molecular Mechanisms of Pharmacological Action 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 Angiogenesis Modulating Agents Growth Inhibitors |
Alkylating Agents Neoplasms by Histologic Type Eye Neoplasms Eye Diseases Growth Substances Temozolomide Immunosuppressive Agents Angiogenesis Inhibitors Pharmacologic Actions Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms Antineoplastic Agents, Alkylating Leprostatic Agents |