Vaccine Therapy in Treating Patients With Stage IV Melanoma

June 21, 2013 updated by: Southwest Oncology Group

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southwest Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Study Completion (Actual)

March 1, 2006

Study Registration Dates

First Submitted

August 5, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

June 24, 2013

Last Update Submitted That Met QC Criteria

June 21, 2013

Last Verified

April 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000069468
  • SWOG-S0116

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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