Vaccine Therapy in Treating Patients With Stage IV Melanoma

NCT00042783 | Completed Phase 2

• 2 other identifiers: CDR0000069468SWOG-S0116
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 7

Brief Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Vaccine therapy may be effective in treating stage IV melanoma. PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have stage IV melanoma.

Conditions

Melanoma (Skin)

Keywords

stage IV melanoma; recurrent melanoma

Interventions

D1/3-MAGE-3-His fusion protein BIOLOGICAL

SB-AS02B adjuvant BIOLOGICAL

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed stage IV melanoma that is considered incurable by surgery, radiotherapy, or limb perfusion * M1a or M1b disease * Measurable disease outside prior field of limb perfusion * Metastatic mucosal melanoma allowed * MAGE-3 positive by reverse transcription polymerase chain reaction * No uveal or choroidal primary melanoma * No prior or concurrent brain metastases by CT scan or MRI of the brain PATIENT CHARACTERISTICS: Age * Not specified Performance status * Zubrod 0-1 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Hepatitis B surface antigen negative * Hepatitis C negative * No liver cirrhosis * No unstable liver disease * No coagulation disorders Renal * Not specified Cardiovascular * No major cardiovascular illness * No myocardial infarction within the past 6 months Pulmonary * No major pulmonary illness Other * Not pregnant or nursing * Fertile patients must use effective contraception * HIV negative * No AIDS or HIV-1-associated complex * No chronic alcohol abuse or drug addiction * No systemic infections * No prior active autoimmune disease * No other 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 from which the patient is currently disease-free PRIOR CONCURRENT THERAPY: Biologic therapy * At least 4 weeks since prior adjuvant biologic therapy * No prior biologic therapy for stage IV melanoma * No prior MAGE-3 peptide or protein vaccine preparation Chemotherapy * At least 4 weeks since prior adjuvant chemotherapy * No prior chemotherapy for stage IV melanoma Endocrine therapy * Not specified Radiotherapy * At least 4 weeks since prior adjuvant radiotherapy Surgery * At least 4 weeks since prior surgery Other * See Disease Characteristics * At least 3 weeks since prior limb perfusion and recovered * At least 4 weeks since other prior adjuvant therapy * No other prior therapy for stage IV melanoma

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 (7)

Arizona Cancer Center at University of Arizona Health Sciences Center

Tucson, Arizona, 85724, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90033, United States

Location

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Veterans Affairs Medical Center - Biloxi

Biloxi, Mississippi, 39531-2410, United States

Location

CCOP - Columbia River Oncology Program

Portland, Oregon, 97225, United States

Location

University of Washington School of Medicine

Seattle, Washington, 98195-6527, United States

Location

MeSH Terms

Conditions

Melanoma

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

Study Officials

• Jeffrey S. Weber, MD, PhD

  University of Southern California

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: August 5, 2002
• First Posted: January 27, 2003
• Study Start: September 1, 2002
• Study Completion: March 1, 2006
• Last Updated: June 24, 2013

Record last verified: 2004-04

Locations

US (7)