MedPath

Interferon Alfa and Thalidomide in Treating Patients With Stage IV Melanoma

Phase 2
Completed
Conditions
Melanoma (Skin)
Registration Number
NCT00026520
Lead Sponsor
SWOG Cancer Research Network
Brief Summary

RATIONALE: Interferon alfa may interfere with the growth of cancer cells and slow the growth of the tumor. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining interferon alfa with thalidomide may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining interferon alfa with thalidomide in treating patients who have stage IV melanoma.

Detailed Description

OBJECTIVES:

* Determine the 6-month progression-free survival rate in patients with stage IV melanoma treated with interferon alfa and thalidomide.

* Determine the confirmed and unconfirmed complete and partial response rates in patients with measurable disease treated with this regimen.

* Determine the quantitative and qualitative toxic effects of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive interferon alfa subcutaneously twice daily and oral thalidomide once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 2 additional courses after documentation of CR.

Patients are followed every 3 months for 2 years and then every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (94)

Veterans Affairs Medical Center - Shreveport

🇺🇸

Shreveport, Louisiana, United States

CCOP - Atlanta Regional

🇺🇸

Atlanta, Georgia, United States

MBCCOP - University of Illinois at Chicago

🇺🇸

Chicago, Illinois, United States

University of Mississippi Medical Center

🇺🇸

Jackson, Mississippi, United States

Boston Medical Center

🇺🇸

Boston, Massachusetts, United States

Veterans Affairs Medical Center - Lexington

🇺🇸

Lexington, Kentucky, United States

Veterans Affairs Medical Center - West Los Angeles

🇺🇸

Los Angeles, California, United States

Veterans Affairs Medical Center - Chicago (Westside Hospital)

🇺🇸

Chicago, Illinois, United States

Veterans Affairs Medical Center - Tucson

🇺🇸

Tucson, Arizona, United States

Cancer Center and Beckman Research Institute, City of Hope

🇺🇸

Duarte, California, United States

USC/Norris Comprehensive Cancer Center and Hospital

🇺🇸

Los Angeles, California, United States

CCOP - Central Illinois

🇺🇸

Decatur, Illinois, United States

Arizona Cancer Center

🇺🇸

Tucson, Arizona, United States

Veterans Affairs Medical Center - Boston (Jamaica Plain)

🇺🇸

Jamaica Plain, Massachusetts, United States

Louisiana State University Health Sciences Center - Shreveport

🇺🇸

Shreveport, Louisiana, United States

Veterans Affairs Outpatient Clinic - Martinez

🇺🇸

Martinez, California, United States

Veterans Affairs Medical Center - Jackson

🇺🇸

Jackson, Mississippi, United States

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

🇺🇸

Hines, Illinois, United States

CCOP - Bay Area Tumor Institute

🇺🇸

Oakland, California, United States

Tulane University School of Medicine

🇺🇸

New Orleans, Louisiana, United States

CCOP - St. Louis-Cape Girardeau

🇺🇸

Saint Louis, Missouri, United States

University of Arkansas for Medical Sciences

🇺🇸

Little Rock, Arkansas, United States

Herbert Irving Comprehensive Cancer Center

🇺🇸

New York, New York, United States

Jonsson Comprehensive Cancer Center, UCLA

🇺🇸

Los Angeles, California, United States

Cleveland Clinic Taussig Cancer Center

🇺🇸

Cleveland, Ohio, United States

Veterans Affairs Medical Center - Little Rock (McClellan)

🇺🇸

Little Rock, Arkansas, United States

CCOP - Montana Cancer Consortium

🇺🇸

Billings, Montana, United States

Loyola University Medical Center

🇺🇸

Maywood, Illinois, United States

Veterans Affairs Medical Center - Seattle

🇺🇸

Seattle, Washington, United States

Veterans Affairs Medical Center - Wichita

🇺🇸

Wichita, Kansas, United States

Providence Hospital - Southfield

🇺🇸

Southfield, Michigan, United States

Albert B. Chandler Medical Center, University of Kentucky

🇺🇸

Lexington, Kentucky, United States

MBCCOP - LSU Health Sciences Center

🇺🇸

New Orleans, Louisiana, United States

Veterans Affairs Medical Center - Albany

🇺🇸

Albany, New York, United States

CCOP - Upstate Carolina

🇺🇸

Spartanburg, South Carolina, United States

CCOP - Virginia Mason Research Center

🇺🇸

Seattle, Washington, United States

Keesler Medical Center - Keesler AFB

🇺🇸

Keesler AFB, Mississippi, United States

Veterans Affairs Medical Center - Temple

🇺🇸

Temple, Texas, United States

CCOP - Columbus

🇺🇸

Columbus, Ohio, United States

Madigan Army Medical Center

🇺🇸

Tacoma, Washington, United States

Brooke Army Medical Center

🇺🇸

Fort Sam Houston, Texas, United States

Arthur G. James Cancer Hospital - Ohio State University

🇺🇸

Columbus, Ohio, United States

MBCCOP - University of New Mexico HSC

🇺🇸

Albuquerque, New Mexico, United States

Medical University of South Carolina

🇺🇸

Charleston, South Carolina, United States

Swedish Cancer Institute

🇺🇸

Seattle, Washington, United States

University of Texas Medical Branch

🇺🇸

Galveston, Texas, United States

CCOP - Greenville

🇺🇸

Greenville, South Carolina, United States

UCSF Cancer Center and Cancer Research Institute

🇺🇸

San Francisco, California, United States

Veterans Affairs Medical Center - Cincinnati

🇺🇸

Cincinnati, Ohio, United States

Barrett Cancer Center, The University Hospital

🇺🇸

Cincinnati, Ohio, United States

University of Texas Health Science Center at San Antonio

🇺🇸

San Antonio, Texas, United States

Veterans Affairs Medical Center - San Antonio (Murphy)

🇺🇸

San Antonio, Texas, United States

Huntsman Cancer Institute

🇺🇸

Salt Lake City, Utah, United States

Veterans Affairs Medical Center - Salt Lake City

🇺🇸

Salt Lake City, Utah, United States

MBCCOP - Gulf Coast

🇺🇸

Mobile, Alabama, United States

Chao Family Comprehensive Cancer Center

🇺🇸

Orange, California, United States

CCOP - Santa Rosa Memorial Hospital

🇺🇸

Santa Rosa, California, United States

David Grant Medical Center

🇺🇸

Travis Air Force Base, California, United States

Cancer Research Center of Hawaii

🇺🇸

Honolulu, Hawaii, United States

Dwight David Eisenhower Army Medical Center

🇺🇸

Fort Gordon, Georgia, United States

CCOP - Duluth

🇺🇸

Duluth, Minnesota, United States

CCOP - Kansas City

🇺🇸

Kansas City, Missouri, United States

University of Rochester Medical Center

🇺🇸

Rochester, New York, United States

Veterans Affairs Medical Center - Charleston

🇺🇸

Charleston, South Carolina, United States

Veterans Affairs Medical Center - Dayton

🇺🇸

Dayton, Ohio, United States

CCOP - Scott and White Hospital

🇺🇸

Temple, Texas, United States

CCOP - Cancer Research for the Ozarks

🇺🇸

Springfield, Missouri, United States

CCOP - Wichita

🇺🇸

Wichita, Kansas, United States

Veterans Affairs Medical Center - Biloxi

🇺🇸

Biloxi, Mississippi, United States

Veterans Affairs Medical Center - Houston

🇺🇸

Houston, Texas, United States

Veterans Affairs Medical Center - Kansas City

🇺🇸

Kansas City, Missouri, United States

CCOP - Northwest

🇺🇸

Tacoma, Washington, United States

St. Louis University Health Sciences Center

🇺🇸

Saint Louis, Missouri, United States

CCOP - Dayton

🇺🇸

Kettering, Ohio, United States

Veterans Affairs Medical Center - Albuquerque

🇺🇸

Albuquerque, New Mexico, United States

CCOP - Toledo Community Hospital Oncology Program

🇺🇸

Toledo, Ohio, United States

CCOP - Columbia River Program

🇺🇸

Portland, Oregon, United States

CCOP - Greater Phoenix

🇺🇸

Phoenix, Arizona, United States

Oklahoma Medical Research Foundation

🇺🇸

Oklahoma City, Oklahoma, United States

Oregon Cancer Center

🇺🇸

Portland, Oregon, United States

Veterans Affairs Medical Center - Portland

🇺🇸

Portland, Oregon, United States

University of Colorado Cancer Center

🇺🇸

Denver, Colorado, United States

CCOP - Ann Arbor Regional

🇺🇸

Ann Arbor, Michigan, United States

University of Michigan Comprehensive Cancer Center

🇺🇸

Ann Arbor, Michigan, United States

Veterans Affairs Medical Center - Phoenix (Hayden)

🇺🇸

Phoenix, Arizona, United States

University of California Davis Medical Center

🇺🇸

Sacramento, California, United States

Veterans Affairs Medical Center - Denver

🇺🇸

Denver, Colorado, United States

Barbara Ann Karmanos Cancer Institute

🇺🇸

Detroit, Michigan, United States

CCOP - Southeast Cancer Control Consortium

🇺🇸

Winston-Salem, North Carolina, United States

Veterans Affairs Medical Center - Ann Arbor

🇺🇸

Ann Arbor, Michigan, United States

Veterans Affairs Medical Center - Oklahoma City

🇺🇸

Oklahoma City, Oklahoma, United States

Veterans Affairs Medical Center - Detroit

🇺🇸

Detroit, Michigan, United States

Henry Ford Hospital

🇺🇸

Detroit, Michigan, United States

University of Kansas Medical Center

🇺🇸

Kansas City, Kansas, United States

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