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

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Trial Identification

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

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

Study ID: NCT00068666

Study Description

Brief 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Mayo Clinic Scottsdale, Scottsdale, Arizona, United States

Mayo Clinic - Jacksonville, Jacksonville, Florida, United States

St. Francis Hospital and Health Centers - Beech Grove Campus, Beech Grove, Indiana, United States

McFarland Clinic, PC, Ames, Iowa, United States

Cedar Rapids Oncology Associates, Cedar Rapids, Iowa, United States

Mercy Capitol Hospital, Des Moines, Iowa, United States

CCOP - Iowa Oncology Research Association, Des Moines, Iowa, United States

John Stoddard Cancer Center at Iowa Methodist Medical Center, Des Moines, Iowa, United States

Medical Oncology and Hematology Associates at John Stoddard Cancer Center, Des Moines, Iowa, United States

Medical Oncology and Hematology Associates at Mercy Cancer Center, Des Moines, Iowa, United States

Mercy Cancer Center at Mercy Medical Center - Des Moines, Des Moines, Iowa, United States

John Stoddard Cancer Center at Iowa Lutheran Hospital, Des Moines, Iowa, United States

Siouxland Hematology-Oncology Associates, LLP, Sioux City, Iowa, United States

Mercy Medical Center - Sioux City, Sioux City, Iowa, United States

St. Luke's Regional Medical Center, Sioux City, Iowa, United States

Medical Oncology and Hematology Associates - West Des Moines, West Des Moines, Iowa, United States

Fairview Ridges Hospital, Burnsville, Minnesota, United States

Mercy and Unity Cancer Center at Mercy Hospital, Coon Rapids, Minnesota, United States

Fairview Southdale Hospital, Edina, Minnesota, United States

Mercy and Unity Cancer Center at Unity Hospital, Fridley, Minnesota, United States

Hutchinson Area Health Care, Hutchinson, Minnesota, United States

Meeker County Memorial Hospital, Lichfield, Minnesota, United States

HealthEast Cancer Care at St. John's Hospital, Maplewood, Minnesota, United States

Minnesota Oncology Hematology, PA at Maplewood Cancer Center, Maplewood, Minnesota, United States

Virginia Piper Cancer Institute at Abbott-Northwestern Hospital, Minneapolis, Minnesota, United States

Hennepin County Medical Center - Minneapolis, Minneapolis, Minnesota, United States

Hubert H. Humphrey Cancer Center at North Memorial Medical Center, Robbinsdale, Minnesota, United States

Mayo Clinic Cancer Center, Rochester, Minnesota, United States

CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, United States

Saint Francis Cancer Center, Shakopee, Minnesota, United States

St. Joseph's Hospital, St Paul, Minnesota, United States

Park Nicollet Health Services, St. Louis Park, Minnesota, United States

Regions Hospital Cancer Care Center, St. Paul, Minnesota, United States

United Hospital, St. Paul, Minnesota, United States

Ridgeview Medical Center, Waconia, Minnesota, United States

Minnesota Oncology Hematology, PA - Woodbury, Woodbury, Minnesota, United States

Woodwinds Health Campus, Woodbury, Minnesota, United States

Grandview Hospital, Dayton, Ohio, United States

David L. Rike Cancer Center at Miami Valley Hospital, Dayton, Ohio, United States

CCOP - Dayton, Dayton, Ohio, United States

Middletown Regional Hospital, Middletown, Ohio, United States

Rapid City Regional Hospital, Rapid City, South Dakota, United States

Avera Cancer Institute, Sioux Falls, South Dakota, United States

Medical X-Ray Center, PC, Sioux Falls, South Dakota, United States

Sioux Valley Hospital and University of South Dakota Medical Center, Sioux Falls, South Dakota, United States

Contact Details

Name: Svetomir Markovic, MD, PhD

Affiliation: Mayo Clinic

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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