A Phase II Pilot Study of Stereotactic Radiosurgery for Limited Malignant Melanoma Brain Metastases
Phase 2
N/A
N/A
N/A
N/A
Not Enrolling
Both
Melanoma (Skin), Metastatic Cancer
Both
Melanoma (Skin), Metastatic Cancer
Trial Information
A Phase II Pilot Study of Stereotactic Radiosurgery for Limited Malignant Melanoma Brain Metastases
OBJECTIVES: I. Estimate the 6 month intracranial progression rate and 6 month overall
survival rate in patients with limited brain metastases from malignant melanoma undergoing
whole brain radiotherapy followed by stereotactic radiosurgery boost. II. Evaluate the
qualitative and quantitative toxic effects of this regimen in these patients.
OUTLINE: Patients undergo whole brain radiotherapy 5 days a week for 3 weeks, followed 3-5
weeks later by stereotactic radiosurgery. Patients are followed every 3 months until death.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 2 years.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically proven malignant melanoma at primary or any
metastatic site Bidimensionally measurable disease by MRI scan Must have 1-6 enhancing
brain metastases If at least 2 lesions are present, only 1 lesion may be greater than 3 cm
in maximum diameter
PATIENT CHARACTERISTICS: Age: Not specified Performance status: SWOG 0-2 Life expectancy:
Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified
Other: Not pregnant or nursing Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic response modifier or
immunotherapy Chemotherapy: No concurrent chemotherapy with whole brain radiotherapy Prior
systemic chemotherapy allowed Endocrine therapy: Not specified Radiotherapy: No prior
stereotactic or conventional radiotherapy to any field of the brain Surgery: Prior
surgical resection of brain metastases allowed (provided 1 or 2 measurable brain
metastases remain)
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
James G. Douglas, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Washington
Authority:
United States: Federal Government
Study ID:
CDR0000067090
NCT ID:
NCT00003911
Start Date:
July 1999
Completion Date:
August 2007
Related Keywords:
- Melanoma (Skin)
- Metastatic Cancer
- stage IV melanoma
- recurrent melanoma
- tumors metastatic to brain
- Melanoma
- Neoplasm Metastasis
- Neoplasms
- Neoplasms, Second Primary
Name | Location |
|---|---|
| Arizona Cancer Center | Tucson, Arizona 85724 |
| University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
| Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
| USC/Norris Comprehensive Cancer Center | Los Angeles, California 90033-0800 |
| Chao Family Comprehensive Cancer Center | Orange, California 92868 |
| University of Colorado Cancer Center | Denver, Colorado 80262 |
| Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
| University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
| Barrett Cancer Center, The University Hospital | Cincinnati, Ohio 45219 |
| CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
| Simmons Cancer Center - Dallas | Dallas, Texas 75235-9154 |
| University of Washington Medical Center | Seattle, Washington 98195-6043 |
| University of California Davis Medical Center | Sacramento, California 95817 |
| CCOP - Wichita | Wichita, Kansas 67214-3882 |
| University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
| CCOP - Greater Phoenix | Phoenix, Arizona 85006-2726 |
| CCOP - Atlanta Regional | Atlanta, Georgia 30342-1701 |
| CCOP - Kansas City | Kansas City, Missouri 64131 |
| Loyola University Medical Center | Maywood, Illinois 60153 |
| Henry Ford Hospital | Detroit, Michigan 48202 |
| Huntsman Cancer Institute | Salt Lake City, Utah 84112 |
| Veterans Affairs Medical Center - Long Beach | Long Beach, California 90822 |
| Beckman Research Institute, City of Hope | Los Angeles, California 91010 |
| Veterans Affairs Outpatient Clinic - Martinez | Martinez, California 94553 |
| CCOP - Bay Area Tumor Institute | Oakland, California 94609-3305 |
| CCOP - Santa Rosa Memorial Hospital | Santa Rosa, California 95403 |
| David Grant Medical Center | Travis Air Force Base, California 94535 |
| CCOP - Central Illinois | Springfield, Illinois 62526 |
| Veterans Affairs Medical Center - Lexington | Lexington, Kentucky 40511-1093 |
| Tulane University School of Medicine | New Orleans, Louisiana 70112 |
| Veterans Affairs Medical Center - Boston (Jamaica Plain) | Jamaica Plain, Massachusetts 02130 |
| Veterans Affairs Medical Center - Ann Arbor | Ann Arbor, Michigan 48105 |
| St. Louis University Health Sciences Center | Saint Louis, Missouri 63110-0250 |
| CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
| CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
| CCOP - Columbus | Columbus, Ohio 43206 |
| Veterans Affairs Medical Center - Dayton | Dayton, Ohio 45428 |
| CCOP - Dayton | Kettering, Ohio 45429 |
| CCOP - Columbia River Program | Portland, Oregon 97213 |
| CCOP - Greenville | Greenville, South Carolina 29615 |
| University of Texas Medical Branch | Galveston, Texas 77555-1329 |
| Swedish Cancer Institute | Seattle, Washington 98104 |
| MBCCOP - University of New Mexico HSC | Albuquerque, New Mexico 87131 |
| CCOP - Scott and White Hospital | Temple, Texas 76508 |
| Cancer Research Center of Hawaii | Honolulu, Hawaii 96813 |
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
| MBCCOP - Gulf Coast | Mobile, Alabama 36688 |
| Veterans Affairs Medical Center - Tucson | Tucson, Arizona 85723 |
| University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
| Veterans Affairs Medical Center - Little Rock (McClellan) | Little Rock, Arkansas 72205 |
| Veterans Affairs Medical Center - Denver | Denver, Colorado 80220 |
| Dwight David Eisenhower Army Medical Center | Fort Gordon, Georgia 30905-5650 |
| Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) | Hines, Illinois 60141 |
| University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
| Veterans Affairs Medical Center - Wichita | Wichita, Kansas 67218 |
| MBCCOP - LSU Health Sciences Center | New Orleans, Louisiana 70112 |
| Louisiana State University Health Sciences Center - Shreveport | Shreveport, Louisiana 71130-3932 |
| Veterans Affairs Medical Center - Shreveport | Shreveport, Louisiana 71130 |
| Boston Medical Center | Boston, Massachusetts 02118 |
| Veterans Affairs Medical Center - Detroit | Detroit, Michigan 48201-1932 |
| Providence Hospital - Southfield | Southfield, Michigan 48075-9975 |
| Veterans Affairs Medical Center - Biloxi | Biloxi, Mississippi 39531-2410 |
| Veterans Affairs Medical Center - Jackson | Jackson, Mississippi 39216 |
| Keesler Medical Center - Keesler AFB | Keesler AFB, Mississippi 39534-2576 |
| Veterans Affairs Medical Center - Kansas City | Kansas City, Missouri 64128 |
| CCOP - St. Louis-Cape Girardeau | Saint Louis, Missouri 63141 |
| Veterans Affairs Medical Center - Albuquerque | Albuquerque, New Mexico 87108-5138 |
| Herbert Irving Comprehensive Cancer Center | New York, New York 10032 |
| Veterans Affairs Medical Center - Cincinnati | Cincinnati, Ohio 45220-2288 |
| Oklahoma Medical Research Foundation | Oklahoma City, Oklahoma 73104 |
| Veterans Affairs Medical Center - Oklahoma City | Oklahoma City, Oklahoma 73104 |
| Veterans Affairs Medical Center - Portland | Portland, Oregon 97207 |
| Brooke Army Medical Center | Fort Sam Houston, Texas 78234-6200 |
| Texas Tech University Health Science Center | Lubbock, Texas 79415 |
| Veterans Affairs Medical Center - San Antonio (Murphy) | San Antonio, Texas 78284 |
| Veterans Affairs Medical Center - Temple | Temple, Texas 76504 |
| Veterans Affairs Medical Center - Salt Lake City | Salt Lake City, Utah 84148 |
| CCOP - Virginia Mason Research Center | Seattle, Washington 98101 |
| Veterans Affairs Medical Center - Seattle | Seattle, Washington 98108 |
| CCOP - Northwest | Tacoma, Washington 98405-0986 |
| Veterans Affairs Medical Center - Phoenix (Hayden) | Phoenix, Arizona 85012 |
| Veterans Affairs Medical Center - New Orleans | New Orleans, Louisiana 70112 |
| CCOP - Grand Rapids Clinical Oncology Program | Grand Rapids, Michigan 49503 |
| Oregon Cancer Institute at Oregon Health and Science University | Portland, Oregon 97201-3098 |
| University of Washington | Seattle, Washington 98195 |
| MultiCare Radiation Oncology | Tacoma, Washington 98405 |
