A Systemic Temozolomide Treatment Of Melanoma Present In The Central Nervous System
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.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Confirmed response rate
No
Svetomir Markovic, MD, PhD
Study Chair
Mayo Clinic
United States: Federal Government
CDR0000327811
NCT00068666
January 2004
Name | Location |
---|---|
Mayo Clinic Scottsdale | Scottsdale, Arizona 85259 |
Mayo Clinic - Jacksonville | Jacksonville, Florida 32224 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Cedar Rapids Oncology Associates | Cedar Rapids, Iowa 52403 |
Mercy Medical Center - Sioux City | Sioux City, Iowa 51104 |
Siouxland Hematology-Oncology Associates, LLP | Sioux City, Iowa 51101 |
St. Luke's Regional Medical Center | Sioux City, Iowa 51104 |
Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids, Minnesota 55433 |
Fairview Southdale Hospital | Edina, Minnesota 55435 |
Mercy and Unity Cancer Center at Unity Hospital | Fridley, Minnesota 55432 |
Hutchinson Area Health Care | Hutchinson, Minnesota 55350 |
Meeker County Memorial Hospital | Lichfield, Minnesota 55355 |
HealthEast Cancer Care at St. John's Hospital | Maplewood, Minnesota 55109 |
Hennepin County Medical Center - Minneapolis | Minneapolis, Minnesota 55415 |
Regions Hospital Cancer Care Center | St. Paul, Minnesota 55101 |
United Hospital | St. Paul, Minnesota 55102 |
Ridgeview Medical Center | Waconia, Minnesota 55387 |
Minnesota Oncology Hematology, PA - Woodbury | Woodbury, Minnesota 55125 |
Medical X-Ray Center, PC | Sioux Falls, South Dakota 57105 |
Avera Cancer Institute | Sioux Falls, South Dakota 57105 |
Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
CCOP - Dayton | Kettering, Ohio 45429 |
John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
Sioux Valley Hospital and University of South Dakota Medical Center | Sioux Falls, South Dakota 57117-5134 |
St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove, Indiana 46107 |
John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
Mercy Capitol Hospital | Des Moines, Iowa 50307 |
Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines, Iowa 50309 |
Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines, Iowa 50314 |
Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
Medical Oncology and Hematology Associates - West Des Moines | West Des Moines, Iowa 50266 |
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital | Minneapolis, Minnesota 55407 |
Hubert H. Humphrey Cancer Center at North Memorial Medical Center | Robbinsdale, Minnesota 55422-2900 |
Park Nicollet Health Services | St. Louis Park, Minnesota 55416 |
Grandview Hospital | Dayton, Ohio 45405 |
David L. Rike Cancer Center at Miami Valley Hospital | Dayton, Ohio 45409 |
Middletown Regional Hospital | Middletown, Ohio 45044 |
Saint Francis Cancer Center | Shakopee, Minnesota 55379 |
St. Joseph's Hospital | St Paul, Minnesota 55102 |
McFarland Clinic, PC | Ames, Iowa 50010 |
Woodwinds Health Campus | Woodbury, Minnesota 55125 |
Minnesota Oncology Hematology, PA at Maplewood Cancer Center | Maplewood, Minnesota 55109 |