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Vaccine Therapy in Treating Patients With Stage IV Melanoma

Sponsor
Southwest Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00042783
Collaborator
National Cancer Institute (NCI) (NIH)
7
Locations
42
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: D1/3-MAGE-3-His fusion protein
  • Biological: SB-AS02B adjuvant
 Phase 2

Detailed Description

OBJECTIVES:

  • Determine the feasibility of treating patients with stage IV melanoma with D1/3-MAGE-3-His fusion protein with SB-AS02B adjuvant.

  • Determine the clinically confirmed response rates (partial and complete responses) of patients treated with this regimen.

  • Determine the 6-month progression-free survival rate of patients treated with this regimen.

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

  • Determine immune responses in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive D1/3-MAGE-3-His fusion protein emulsified in SB-AS02B adjuvant intramuscularly once every 3 weeks for a total of 12 weeks (4 injections). In the absence of disease progression or unacceptable toxicity, patients receive a second 12-week course beginning at week 16.

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

PROJECTED ACCRUAL: A total of 25-45 patients will be accrued for this study within 5-9 months.

Study Design

Study Type:
Interventional
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Trial Of A D1/3-MAGE3-HIS Fusion Protein (NSC-719274) With Adjuvant SBAS02B (NSC-719275) For Patients With Stage IV, M1a or M1b Metastatic Melanoma
Study Start Date :
Sep 1, 2002
Actual Study Completion Date :
Mar 1, 2006

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Arizona Cancer Center at University of Arizona Health Sciences Center Tucson Arizona United States 85724
    2 USC/Norris Comprehensive Cancer Center and Hospital Los Angeles California United States 90033
    3 Jonsson Comprehensive Cancer Center, UCLA Los Angeles California United States 90095-1781
    4 Barbara Ann Karmanos Cancer Institute Detroit Michigan United States 48201-1379
    5 Veterans Affairs Medical Center - Biloxi Biloxi Mississippi United States 39531-2410
    6 CCOP - Columbia River Oncology Program Portland Oregon United States 97225
    7 University of Washington School of Medicine Seattle Washington United States 98195-6527

    Sponsors and Collaborators

    • Southwest Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Jeffrey S. Weber, MD, PhD, University of Southern California

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00042783
    Other Study ID Numbers:
    • CDR0000069468
    • SWOG-S0116
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Jun 24, 2013
    Last Verified:
    Apr 1, 2004
    Keywords provided by , ,
    stage IV melanoma
    recurrent melanoma
    Additional relevant MeSH terms:
    Melanoma

    Study Results

    No Results Posted as of Jun 24, 2013