NCT00068666

Temozolomide and Radiation Therapy in Treating Patients With Stage IV Malignant Melanoma With Measurable and Unresectable Cancer of the Central Nervous System

A Systemic Temozolomide Treatment Of Melanoma Present In The Central Nervous System

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: Primary * Determine the response rate in patients with stage IV malignant melanoma with measurable and unresectable disease of the central nervous system treated with temozolomide and radiotherapy. Secondary * Determine the safety of this regimen in these patients. * Determine the survival of patients treated with this regimen. * Determine the effect of this regimen on performance status and mental status of these patients. * Determine the response of extra-cranial disease in patients treated with this regimen. 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.

Conditions

• Melanoma (Skin)
• Metastatic Cancer

Interventions

Type	Name	Description
DRUG	temozolomide
RADIATION	radiation therapy

Timeline

• Start date: 2004-01-01
• Primary completion: 2005-03-01
• Completion: 2010-03-01
• First posted: 2003-09-11
• Last updated: 2016-12-15

Locations

45 sites across 1 country: United States