Temozolomide and Radiation Therapy in Treating Patients With Stage IV Malignant Melanoma With Measurable and Unresectable Cancer of the Central Nervous System
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.
Radiation: radiation therapy
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Systemic Temozolomide Treatment Of Melanoma Present In The Central Nervous System|
- Confirmed response rate [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Change in performance status [ Designated as safety issue: No ]
|Study Start Date:||January 2004|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
- 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.
- 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.
Show 45 Study Locations
|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|
|Investigator:||Ravi D. Rao, MD, MBBS||Mayo Clinic|
|Investigator:||Richard L. Deming, MD||Mercy Therapeutic Radiology Associates, PC at Mercy Medical Center - Des Moines|