S9903: Whole Brain Radiotherapy Followed By Stereotactic Radiosurgery for Limited Malignant Melanoma Brain Metastases

NCT00003911 | Terminated Phase 2

• 3 other identifiers: CDR0000067090S9903U10CA032102
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 86

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Stereotactic radiosurgery may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of radiation therapy followed by stereotactic radiosurgery in treating patients who have brain metastases from malignant melanoma.

Conditions

Melanoma (Skin); Metastatic Cancer

Keywords

stage IV melanoma; recurrent melanoma; tumors metastatic to brain

Interventions

stereotactic radiosurgery RADIATION

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator

Study Sites (86)

MBCCOP - Gulf Coast

Mobile, Alabama, 36652, United States

Location

CCOP - Greater Phoenix

Phoenix, Arizona, 85006-2726, United States

Location

Veterans Affairs Medical Center - Phoenix (Hayden)

Phoenix, Arizona, 85012, United States

Location

Veterans Affairs Medical Center - Tucson

Tucson, Arizona, 85723, United States

Location

Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Veterans Affairs Medical Center - Little Rock (McClellan)

Little Rock, Arkansas, 72205, United States

Location

Veterans Affairs Medical Center - Long Beach

Long Beach, California, 90822, United States

Location

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033-0800, United States

Location

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

Beckman Research Institute, City of Hope

Los Angeles, California, 91010, United States

Location

Veterans Affairs Outpatient Clinic - Martinez

Martinez, California, 94553, United States

Location

CCOP - Bay Area Tumor Institute

Oakland, California, 94609-3305, United States

Location

Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location

CCOP - Santa Rosa Memorial Hospital

Santa Rosa, California, 95403, United States

Location

David Grant Medical Center

Travis Air Force Base, California, 94535, United States

Location

Veterans Affairs Medical Center - Denver

Denver, Colorado, 80220, United States

Location

University of Colorado Cancer Center

Denver, Colorado, 80262, United States

Location

CCOP - Atlanta Regional

Atlanta, Georgia, 30342-1701, United States

Location

Dwight David Eisenhower Army Medical Center

Fort Gordon, Georgia, 30905-5650, United States

Location

Cancer Research Center of Hawaii

Honolulu, Hawaii, 96813, United States

Location

CCOP - Central Illinois

Decatur, Illinois, 62526, United States

Location

Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)

Hines, Illinois, 60141, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160-7357, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214-3882, United States

Location

Veterans Affairs Medical Center - Wichita

Wichita, Kansas, 67218, United States

Location

Veterans Affairs Medical Center - Lexington

Lexington, Kentucky, 40511-1093, United States

Location

MBCCOP - LSU Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Tulane University School of Medicine

New Orleans, Louisiana, 70112, United States

Location

Veterans Affairs Medical Center - New Orleans

New Orleans, Louisiana, 70112, United States

Location

Louisiana State University Health Sciences Center - Shreveport

Shreveport, Louisiana, 71130-3932, United States

Location

Veterans Affairs Medical Center - Shreveport

Shreveport, Louisiana, 71130, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Veterans Affairs Medical Center - Boston (Jamaica Plain)

Jamaica Plain, Massachusetts, 02130, United States

Location

Veterans Affairs Medical Center - Ann Arbor

Ann Arbor, Michigan, 48105, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0752, United States

Location

Veterans Affairs Medical Center - Detroit

Detroit, Michigan, 48201-1932, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

CCOP - Grand Rapids Clinical Oncology Program

Grand Rapids, Michigan, 49503, United States

Location

Providence Hospital - Southfield

Southfield, Michigan, 48075-9975, United States

Location

Veterans Affairs Medical Center - Biloxi

Biloxi, Mississippi, 39531-2410, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216-4505, United States

Location

Veterans Affairs Medical Center - Jackson

Jackson, Mississippi, 39216, United States

Location

Keesler Medical Center - Keesler AFB

Keesler Air Force Base, Mississippi, 39534-2576, United States

Location

Veterans Affairs Medical Center - Kansas City

Kansas City, Missouri, 64128, United States

Location

CCOP - Kansas City

Kansas City, Missouri, 64131, United States

Location

CCOP - Cancer Research for the Ozarks

Springfield, Missouri, 65807, United States

Location

St. Louis University Health Sciences Center

St Louis, Missouri, 63110-0250, United States

Location

CCOP - St. Louis-Cape Girardeau

St Louis, Missouri, 63141, United States

Location

CCOP - Montana Cancer Consortium

Billings, Montana, 59101, United States

Location

Veterans Affairs Medical Center - Albuquerque

Albuquerque, New Mexico, 87108-5138, United States

Location

MBCCOP - University of New Mexico HSC

Albuquerque, New Mexico, 87131, United States

Location

Herbert Irving Comprehensive Cancer Center

New York, New York, 10032, United States

Location

Barrett Cancer Center, The University Hospital

Cincinnati, Ohio, 45219, United States

Location

Veterans Affairs Medical Center - Cincinnati

Cincinnati, Ohio, 45220-2288, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

CCOP - Columbus

Columbus, Ohio, 43206, United States

Location

Veterans Affairs Medical Center - Dayton

Dayton, Ohio, 45428, United States

Location

CCOP - Dayton

Kettering, Ohio, 45429, United States

Location

Oklahoma Medical Research Foundation

Oklahoma City, Oklahoma, 73104, United States

Location

Veterans Affairs Medical Center - Oklahoma City

Oklahoma City, Oklahoma, 73104, United States

Location

Oregon Cancer Institute at Oregon Health and Science University

Portland, Oregon, 97201-3098, United States

Location

Veterans Affairs Medical Center - Portland

Portland, Oregon, 97207, United States

Location

CCOP - Columbia River Program

Portland, Oregon, 97213, United States

Location

CCOP - Greenville

Greenville, South Carolina, 29615, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

Simmons Cancer Center - Dallas

Dallas, Texas, 75235-9154, United States

Location

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555-0209, United States

Location

Texas Tech University Health Science Center

Lubbock, Texas, 79423, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78284-7811, United States

Location

Veterans Affairs Medical Center - San Antonio (Murphy)

San Antonio, Texas, 78284, United States

Location

Veterans Affairs Medical Center - Temple

Temple, Texas, 76504, United States

Location

CCOP - Scott and White Hospital

Temple, Texas, 76508, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84132, United States

Location

Veterans Affairs Medical Center - Salt Lake City

Salt Lake City, Utah, 84148, United States

Location

CCOP - Virginia Mason Research Center

Seattle, Washington, 98101, United States

Location

Swedish Cancer Institute

Seattle, Washington, 98104, United States

Location

Veterans Affairs Medical Center - Seattle

Seattle, Washington, 98108, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195-6043, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

CCOP - Northwest

Tacoma, Washington, 98405-0986, United States

Location

MultiCare Radiation Oncology

Tacoma, Washington, 98405, United States

Location

MeSH Terms

Conditions

Melanoma; Neoplasm Metastasis; Brain Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• James G. Douglas, MD

  University of Washington

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: April 12, 2004
• Study Start: July 1, 1999
• Primary Completion: August 1, 2002
• Study Completion: August 1, 2007
• Last Updated: January 31, 2013

Record last verified: 2013-01

Locations

US (86)