Temozolomide and Radiation Therapy in Treating Patients With Stage IV Malignant Melanoma With Measurable and Unresectable Cancer of the Central Nervous System
- Conditions
- Melanoma (Skin)Metastatic Cancer
- Interventions
- Radiation: radiation therapy
- Registration Number
- NCT00068666
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 41
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description radiation + temozolomide radiation therapy 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. radiation + temozolomide temozolomide 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.
- Primary Outcome Measures
Name Time Method Confirmed response rate Up to 5 years
- Secondary Outcome Measures
Name Time Method Overall survival Up to 5 years Change in performance status Up to 5 years Progression-free survival Up to 5 years
Trial Locations
- Locations (45)
John Stoddard Cancer Center at Iowa Methodist Medical Center
🇺🇸Des Moines, Iowa, United States
Mayo Clinic Scottsdale
🇺🇸Scottsdale, Arizona, United States
Mercy Capitol Hospital
🇺🇸Des Moines, Iowa, United States
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States
Ridgeview Medical Center
🇺🇸Waconia, Minnesota, United States
Rapid City Regional Hospital
🇺🇸Rapid City, South Dakota, United States
David L. Rike Cancer Center at Miami Valley Hospital
🇺🇸Dayton, Ohio, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
🇺🇸Des Moines, Iowa, United States
Medical X-Ray Center, PC
🇺🇸Sioux Falls, South Dakota, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center
🇺🇸Des Moines, Iowa, United States
St. Joseph's Hospital
🇺🇸St Paul, Minnesota, United States
Grandview Hospital
🇺🇸Dayton, Ohio, United States
Avera Cancer Institute
🇺🇸Sioux Falls, South Dakota, United States
Regions Hospital Cancer Care Center
🇺🇸St. Paul, Minnesota, United States
Meeker County Memorial Hospital
🇺🇸Lichfield, Minnesota, United States
Fairview Ridges Hospital
🇺🇸Burnsville, 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
Mercy and Unity Cancer Center at Unity Hospital
🇺🇸Fridley, Minnesota, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
🇺🇸Beech Grove, Indiana, United States
McFarland Clinic, PC
🇺🇸Ames, Iowa, United States
Medical Oncology and Hematology Associates - West Des Moines
🇺🇸West Des Moines, Iowa, United States
Fairview Southdale Hospital
🇺🇸Edina, Minnesota, United States
Hutchinson Area Health Care
🇺🇸Hutchinson, Minnesota, United States
Saint Francis Cancer Center
🇺🇸Shakopee, Minnesota, United States
Park Nicollet Health Services
🇺🇸St. Louis Park, Minnesota, United States
United Hospital
🇺🇸St. Paul, Minnesota, United States
CCOP - Dayton
🇺🇸Dayton, Ohio, United States
Sioux Valley Hospital and University of South Dakota Medical Center
🇺🇸Sioux Falls, South Dakota, United States
Mayo Clinic - Jacksonville
🇺🇸Jacksonville, Florida, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
🇺🇸Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital
🇺🇸Des Moines, Iowa, United States
Cedar Rapids Oncology Associates
🇺🇸Cedar Rapids, Iowa, United States
Middletown Regional Hospital
🇺🇸Middletown, Ohio, United States
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Siouxland Hematology-Oncology Associates, LLP
🇺🇸Sioux City, Iowa, United States
Mercy and Unity Cancer Center at Mercy Hospital
🇺🇸Coon Rapids, Minnesota, United States
Mercy Medical Center - Sioux City
🇺🇸Sioux City, Iowa, United States
St. Luke's Regional Medical Center
🇺🇸Sioux City, Iowa, United States
Woodwinds Health Campus
🇺🇸Woodbury, 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
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
Minnesota Oncology Hematology, PA - Woodbury
🇺🇸Woodbury, Minnesota, United States