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

NCT ID: NCT00003911

Last Updated: 2013-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-07-31

Study Completion Date

2007-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Melanoma (Skin) Metastatic Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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stereotactic radiosurgery

Intervention Type RADIATION

Eligibility Criteria

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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)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

SWOG Cancer Research Network

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James G. Douglas, MD

Role: STUDY_CHAIR

University of Washington

Locations

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MBCCOP - Gulf Coast

Mobile, Alabama, United States

Site Status

CCOP - Greater Phoenix

Phoenix, Arizona, United States

Site Status

Veterans Affairs Medical Center - Phoenix (Hayden)

Phoenix, Arizona, United States

Site Status

Veterans Affairs Medical Center - Tucson

Tucson, Arizona, United States

Site Status

Arizona Cancer Center

Tucson, Arizona, United States

Site Status

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

Veterans Affairs Medical Center - Little Rock (McClellan)

Little Rock, Arkansas, United States

Site Status

Veterans Affairs Medical Center - Long Beach

Long Beach, California, United States

Site Status

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, United States

Site Status

Beckman Research Institute, City of Hope

Los Angeles, California, United States

Site Status

Veterans Affairs Outpatient Clinic - Martinez

Martinez, California, United States

Site Status

CCOP - Bay Area Tumor Institute

Oakland, California, United States

Site Status

Chao Family Comprehensive Cancer Center

Orange, California, United States

Site Status

University of California Davis Medical Center

Sacramento, California, United States

Site Status

CCOP - Santa Rosa Memorial Hospital

Santa Rosa, California, United States

Site Status

David Grant Medical Center

Travis Air Force Base, California, United States

Site Status

Veterans Affairs Medical Center - Denver

Denver, Colorado, United States

Site Status

University of Colorado Cancer Center

Denver, Colorado, United States

Site Status

CCOP - Atlanta Regional

Atlanta, Georgia, United States

Site Status

Dwight David Eisenhower Army Medical Center

Fort Gordon, Georgia, United States

Site Status

Cancer Research Center of Hawaii

Honolulu, Hawaii, United States

Site Status

CCOP - Central Illinois

Decatur, Illinois, United States

Site Status

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

Hines, Illinois, United States

Site Status

Loyola University Medical Center

Maywood, Illinois, United States

Site Status

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

CCOP - Wichita

Wichita, Kansas, United States

Site Status

Veterans Affairs Medical Center - Wichita

Wichita, Kansas, United States

Site Status

Veterans Affairs Medical Center - Lexington

Lexington, Kentucky, United States

Site Status

MBCCOP - LSU Health Sciences Center

New Orleans, Louisiana, United States

Site Status

Tulane University School of Medicine

New Orleans, Louisiana, United States

Site Status

Veterans Affairs Medical Center - New Orleans

New Orleans, Louisiana, United States

Site Status

Louisiana State University Health Sciences Center - Shreveport

Shreveport, Louisiana, United States

Site Status

Veterans Affairs Medical Center - Shreveport

Shreveport, Louisiana, United States

Site Status

Boston Medical Center

Boston, Massachusetts, United States

Site Status

Veterans Affairs Medical Center - Boston (Jamaica Plain)

Jamaica Plain, Massachusetts, United States

Site Status

Veterans Affairs Medical Center - Ann Arbor

Ann Arbor, Michigan, United States

Site Status

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Site Status

Veterans Affairs Medical Center - Detroit

Detroit, Michigan, United States

Site Status

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status

Henry Ford Hospital

Detroit, Michigan, United States

Site Status

CCOP - Grand Rapids Clinical Oncology Program

Grand Rapids, Michigan, United States

Site Status

Providence Hospital - Southfield

Southfield, Michigan, United States

Site Status

Veterans Affairs Medical Center - Biloxi

Biloxi, Mississippi, United States

Site Status

University of Mississippi Medical Center

Jackson, Mississippi, United States

Site Status

Veterans Affairs Medical Center - Jackson

Jackson, Mississippi, United States

Site Status

Keesler Medical Center - Keesler AFB

Keesler Air Force Base, Mississippi, United States

Site Status

Veterans Affairs Medical Center - Kansas City

Kansas City, Missouri, United States

Site Status

CCOP - Kansas City

Kansas City, Missouri, United States

Site Status

CCOP - Cancer Research for the Ozarks

Springfield, Missouri, United States

Site Status

St. Louis University Health Sciences Center

St Louis, Missouri, United States

Site Status

CCOP - St. Louis-Cape Girardeau

St Louis, Missouri, United States

Site Status

CCOP - Montana Cancer Consortium

Billings, Montana, United States

Site Status

Veterans Affairs Medical Center - Albuquerque

Albuquerque, New Mexico, United States

Site Status

MBCCOP - University of New Mexico HSC

Albuquerque, New Mexico, United States

Site Status

Herbert Irving Comprehensive Cancer Center

New York, New York, United States

Site Status

Barrett Cancer Center, The University Hospital

Cincinnati, Ohio, United States

Site Status

Veterans Affairs Medical Center - Cincinnati

Cincinnati, Ohio, United States

Site Status

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States

Site Status

CCOP - Columbus

Columbus, Ohio, United States

Site Status

Veterans Affairs Medical Center - Dayton

Dayton, Ohio, United States

Site Status

CCOP - Dayton

Kettering, Ohio, United States

Site Status

Oklahoma Medical Research Foundation

Oklahoma City, Oklahoma, United States

Site Status

Veterans Affairs Medical Center - Oklahoma City

Oklahoma City, Oklahoma, United States

Site Status

Oregon Cancer Institute at Oregon Health and Science University

Portland, Oregon, United States

Site Status

Veterans Affairs Medical Center - Portland

Portland, Oregon, United States

Site Status

CCOP - Columbia River Program

Portland, Oregon, United States

Site Status

CCOP - Greenville

Greenville, South Carolina, United States

Site Status

CCOP - Upstate Carolina

Spartanburg, South Carolina, United States

Site Status

Simmons Cancer Center - Dallas

Dallas, Texas, United States

Site Status

Brooke Army Medical Center

Fort Sam Houston, Texas, United States

Site Status

University of Texas Medical Branch

Galveston, Texas, United States

Site Status

Texas Tech University Health Science Center

Lubbock, Texas, United States

Site Status

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Site Status

Veterans Affairs Medical Center - San Antonio (Murphy)

San Antonio, Texas, United States

Site Status

Veterans Affairs Medical Center - Temple

Temple, Texas, United States

Site Status

CCOP - Scott and White Hospital

Temple, Texas, United States

Site Status

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Site Status

Veterans Affairs Medical Center - Salt Lake City

Salt Lake City, Utah, United States

Site Status

CCOP - Virginia Mason Research Center

Seattle, Washington, United States

Site Status

Swedish Cancer Institute

Seattle, Washington, United States

Site Status

Veterans Affairs Medical Center - Seattle

Seattle, Washington, United States

Site Status

University of Washington Medical Center

Seattle, Washington, United States

Site Status

University of Washington

Seattle, Washington, United States

Site Status

CCOP - Northwest

Tacoma, Washington, United States

Site Status

MultiCare Radiation Oncology

Tacoma, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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S9903

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA032102

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000067090

Identifier Type: -

Identifier Source: org_study_id

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