Interferon Alfa and Thalidomide in Treating Patients With Stage IV Melanoma

NCT00026520 | Completed Phase 2

• 2 other identifiers: CDR0000069046SWOG-S0026
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 94

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.

Conditions

Melanoma (Skin)

Keywords

stage IV melanoma; recurrent melanoma

Interventions

recombinant interferon alfa BIOLOGICAL

thalidomide DRUG

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed stage IV malignant melanoma * Surgically incurable disease * Measurable or evaluable disease * No brain metastases by CT scan or MRI * Prior brain metastases allowed only if completely resected and treated with whole brain radiotherapy * Must have received 1, and only 1, prior systemic therapy for metastatic disease * Chemotherapy, biologic/immunotherapy, hormonal therapy, or combination therapy PATIENT CHARACTERISTICS: Age: * Adult Performance status: * Zubrod 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,000/mm\^3 * Platelet count at least 75,000/mm\^3 Hepatic: * SGOT and/or SGPT no greater than 2.5 times upper limit of normal (ULN) * Bilirubin no greater than ULN Renal: * Creatinine no greater than 1.5 times ULN Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use 2 methods of effective contraception 4 weeks before, during, and for 4 weeks after study * HIV negative * No AIDS or HIV-1-associated complex * No other serious illness * No serious active infections * No sensory neuropathy greater than grade 1 * No prior seizures or concurrent potential risk factors for the development of seizures * No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics * At least 21 days since prior biologic therapy or immunotherapy in the adjuvant or metastatic setting and recovered * No concurrent filgrastim (G-CSF) * No other concurrent biologic therapy Chemotherapy: * See Disease Characteristics * At least 21 days since prior chemotherapy in the adjuvant or metastatic setting and recovered * No concurrent chemotherapy Endocrine therapy: * See Disease Characteristics * At least 21 days since prior hormonal therapy in the adjuvant or metastatic setting and recovered * No concurrent hormonal therapy * No concurrent systemic steroids (including creams) Radiotherapy: * See Disease Characteristics * At least 21 days since prior radiotherapy and recovered * Prior radiotherapy to all known sites of disease allowed if there is objective evidence of progression * No concurrent radiotherapy Surgery: * See Disease Characteristics * At least 21 days since prior surgery for primary or metastatic disease and recovered * No concurrent surgery Other: * At least 21 days since prior systemic therapy or combination regimen for metastatic disease and recovered * At least 21 days since prior adjuvant isolation limb perfusion therapy and recovered * No other concurrent therapy * No other concurrent investigational drugs * No concurrent immunosuppressive medications * Concurrent antihistamines allowed if no alternative medication available

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 (94)

MBCCOP - Gulf Coast

Mobile, Alabama, 36688, 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

Cancer Center and Beckman Research Institute, City of Hope

Duarte, California, 91010-3000, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90033-0804, United States

Location

Veterans Affairs Medical Center - West Los Angeles

Los Angeles, California, 90073, United States

Location

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, 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

UCSF Cancer Center and Cancer Research Institute

San Francisco, California, 94143-0128, 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

University of Colorado Cancer Center

Denver, Colorado, 80010, United States

Location

Veterans Affairs Medical Center - Denver

Denver, Colorado, 80220, 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

MBCCOP - University of Illinois at Chicago

Chicago, Illinois, 60612-7323, United States

Location

Veterans Affairs Medical Center - Chicago (Westside Hospital)

Chicago, Illinois, 60612, 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

Albert B. Chandler Medical Center, University of Kentucky

Lexington, Kentucky, 40536-0084, 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

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

CCOP - Ann Arbor Regional

Ann Arbor, Michigan, 48106, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0752, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Veterans Affairs Medical Center - Detroit

Detroit, Michigan, 48201-1932, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Providence Hospital - Southfield

Southfield, Michigan, 48075-9975, United States

Location

CCOP - Duluth

Duluth, Minnesota, 55805, 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

Veterans Affairs Medical Center - Albany

Albany, New York, 12208, United States

Location

Herbert Irving Comprehensive Cancer Center

New York, New York, 10032, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

CCOP - Southeast Cancer Control Consortium

Winston-Salem, North Carolina, 27104-4241, United States

Location

Veterans Affairs Medical Center - Cincinnati

Cincinnati, Ohio, 45220-2288, United States

Location

Barrett Cancer Center, The University Hospital

Cincinnati, Ohio, 45267-0502, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

CCOP - Columbus

Columbus, Ohio, 43206, United States

Location

Arthur G. James Cancer Hospital - Ohio State University

Columbus, Ohio, 43210-1240, United States

Location

Veterans Affairs Medical Center - Dayton

Dayton, Ohio, 45428, United States

Location

CCOP - Dayton

Kettering, Ohio, 45429, United States

Location

CCOP - Toledo Community Hospital Oncology Program

Toledo, Ohio, 43623-3456, 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 Center

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

Veterans Affairs Medical Center - Charleston

Charleston, South Carolina, 29401-5799, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425-0721, United States

Location

CCOP - Greenville

Greenville, South Carolina, 29615, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, 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

Veterans Affairs Medical Center - Houston

Houston, Texas, 77030, 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, 84112, 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

CCOP - Northwest

Tacoma, Washington, 98405-0986, United States

Location

Madigan Army Medical Center

Tacoma, Washington, 98431-5000, United States

Location

Related Publications (2)

• Hutchins LF, Moon J, Clark JI, Thompson JA, Lange MK, Flaherty LE, Sondak VK. Evaluation of interferon alpha-2B and thalidomide in patients with disseminated malignant melanoma, phase 2, SWOG 0026. Cancer. 2007 Nov 15;110(10):2269-75. doi: 10.1002/cncr.23035.

  PMID: 17932881 RESULT

• Hutchins L, Moon J, Clark J, et al.: Interferon alpha-2b and thalidomide in previously treated patients with disseminated malignant melanoma: SWOG 0026. [Abstract] J Clin Oncol 22 (Suppl 14): A-7527, 716s, 2004.

  RESULT

MeSH Terms

Conditions

Melanoma

Interventions

Interferon-alpha; Thalidomide

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

Intervention Hierarchy (Ancestors)

Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Laura F. Hutchins, MD

  University of Arkansas

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: November 9, 2001
• First Posted: June 25, 2003
• Study Start: November 1, 2001
• Study Completion: April 1, 2006
• Last Updated: June 24, 2013

Record last verified: 2003-04

Locations

US (94)