Vaccine Therapy in Treating Patients With Stage IV Melanoma

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00042783
First received: August 5, 2002
Last updated: June 21, 2013
Last verified: April 2004
  Purpose

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 Intervention Phase
Melanoma (Skin)
Biological: D1/3-MAGE-3-His fusion protein
Biological: SB-AS02B adjuvant
Phase 2

Study Type: Interventional
Study Design: Masking: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: September 2002
Study Completion Date: March 2006
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00042783

Locations
United States, Arizona
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724
United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
United States, Mississippi
Veterans Affairs Medical Center - Biloxi
Biloxi, Mississippi, United States, 39531-2410
United States, Oregon
CCOP - Columbia River Oncology Program
Portland, Oregon, United States, 97225
United States, Washington
University of Washington School of Medicine
Seattle, Washington, United States, 98195-6527
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Jeffrey S. Weber, MD, PhD University of Southern California
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00042783     History of Changes
Other Study ID Numbers: CDR0000069468, SWOG-S0116
Study First Received: August 5, 2002
Last Updated: June 21, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV melanoma
recurrent melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on September 15, 2014