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Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00068666 |
RATIONALE: Drugs used in chemotherapy, such as temozolomide, use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining temozolomide with radiation therapy may make the tumor cells more sensitive to radiation therapy and kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving temozolomide together with radiation therapy works in treating patients with stage IV malignant melanoma with measurable and unresectable cancer limited to the central nervous system.
Condition | Intervention | Phase |
---|---|---|
Brain and Central Nervous System Tumors Melanoma (Skin) |
Drug: temozolomide Procedure: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Systemic Temozolomide Treatment Of Melanoma Present In The Central Nervous System |
Estimated Enrollment: | 41 |
Study Start Date: | January 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive concurrent chemoradiotherapy comprising whole brain radiotherapy daily on days 1-5, 8-13, and 16-21 and oral temozolomide daily on days 1-5. Subsequent treatment with temozolomide repeats every 4 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 18-41 patients will be accrued for this study within 13-30 months.
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 with measurable and unresectable disease limited to the central nervous system (CNS)
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Study Chair: | Svetomir Markovic, MD, PhD | Mayo Clinic |
Investigator: | Paul D. Brown, MD | Mayo Clinic |
Investigator: | Julie E. Hammack, MD | Mayo Clinic |
Investigator: | James N. Ingle, MD | Mayo Clinic |
Investigator: | Edward T. Creagan, MD | Mayo Clinic |
Investigator: | Judith S. Kaur, MD | Mayo Clinic |
Investigator: | Evanthia Galanis, MD | Mayo Clinic |
Investigator: | Charles L. Loprinzi, MD | Mayo Clinic |
Investigator: | Henry C. Pitot, MD | Mayo Clinic |
Investigator: | Michael K. Gornet, MD | Mayo Clinic Scottsdale |
Investigator: | Ravi D. Rao, MD, MBBS | Mayo Clinic |
Investigator: | Richard L. Deming, MD | Mercy Therapeutic Radiology Associates, PC at Mercy Medical Center - Des Moines |
Study ID Numbers: | CDR0000327811, NCCTG-N0274 |
Study First Received: | September 10, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00068666 |
Health Authority: | United States: Federal Government |
stage IV melanoma recurrent melanoma adult tumors metastatic to brain |
Neuroectodermal Tumors Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma Nevus Central Nervous System Neoplasms |
Temozolomide Recurrence Nervous System Neoplasms Neuroendocrine Tumors Melanoma |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Nervous System Diseases Neoplasms, Nerve Tissue Nevi and Melanomas Antineoplastic Agents, Alkylating Alkylating Agents Pharmacologic Actions |