Vaccine Therapy Followed by Biological Therapy in Treating Patients With Stage III or Stage IV Melanoma

This study has been terminated.
(Lack of efficacy)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Southern California
ClinicalTrials.gov Identifier:
NCT00006113
First received: August 3, 2000
Last updated: October 20, 2012
Last verified: October 2012
  Purpose

RATIONALE: Vaccines made from melanoma cells may make the body build an immune response to kill tumor cells. Biological therapies such as interferon gamma and interleukin-2 use different ways to stimulate the immune system and stop cancer cells from growing. Combining vaccine therapy with biological therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying giving vaccine therapy together with interferon gamma and interleukin-2 in treating patients with stage III or stage IV melanoma.


Condition Intervention Phase
Melanoma (Skin)
Biological: MART-1 antigen
Biological: aldesleukin
Biological: gp100 antigen
Biological: recombinant CD40-ligand
Biological: recombinant interferon gamma
Biological: recombinant interleukin-4
Biological: sargramostim
Biological: therapeutic autologous dendritic cells
Biological: therapeutic tumor infiltrating lymphocytes
Biological: tyrosinase peptide
Radiation: Candida albicans skin test reagent
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Trial of a MART-1/gp100/Tyrosinase Peptide-Pulsed Dendritic Cell Vaccine Treated With CD40 Ligand/Gamma Interferon With Subcutaneous IL-2 for Patients With Metastatic Melanoma

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Enrollment: 25
Study Start Date: June 1999
Study Completion Date: April 2006
Primary Completion Date: May 2003 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the clinical response rate and immune response in HLA-A2 positive patients with stage III or IV melanoma after receiving autologous dendritic cells pulsed with melanoma antigen peptides (MART-1:26-35, gp100:209-217, and tyrosinase:368-376) and treated ex vivo with CD40-ligand and interferon gamma, followed by interleukin-2 in vivo.
  • Determine the toxicities of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients undergo leukapheresis to harvest autologous dendritic cells (ADCs). Melanoma peptides (MART-1:26-35, gp100:209-217, and tyrosinase:368-376) are pulsed separately onto ADCs, which are also treated ex vivo with CD40-ligand, interferon gamma, interleukin-4, sargramostim (GM-CSF), and Candida albicans skin test reagent. Patients receive each melanoma peptide pulsed ADC vaccine separately via 3 successive 10 minute infusions on day 1. Patients then receive interleukin-2 subcutaneously every 12 hours on days 2-6. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed at 4 weeks, then every 3 months for 2 years, then every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for this study within 18-24 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed metastatic melanoma

    • Measurable disease after attempted curative surgery
    • Unresectable stage III or IV uveal melanoma
    • Metastatic mucosal melanoma
  • HLA-A2.1 positive
  • No disease progression following high dose interleukin-2 (600,000 or 720,000 IU/kg every 8 hours)

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC at least 3,000/mm^3
  • Platelet count at least 75,000/mm^3
  • Hemoglobin at least 9.0 g/dL
  • No coagulation disorders

Hepatic:

  • Bilirubin no greater than 2.0 mg/dL

Renal:

  • Creatinine no greater than 2.0 mg/dL

Cardiovascular:

  • No myocardial infarction within the past 6 months
  • Patients with documented or suspected coronary artery disease must undergo stress thallium test
  • No major cardiovascular illness

Pulmonary:

  • No major pulmonary illness

Immunologic:

  • HIV negative
  • Hepatitis B surface antigen negative
  • Hepatitis C antibody negative
  • No history of uveitis or autoimmune inflammatory eye disease

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No major systemic infection
  • No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or basal cell skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics
  • No prior MART-1:26-35, gp100:209-217, or tyrosinase:368-376 antigens

Chemotherapy:

  • At least 1 month since prior chemotherapy for melanoma

Endocrine therapy:

  • No concurrent steroid therapy

Radiotherapy:

  • At least 1 month since prior radiotherapy for melanoma

Surgery:

  • See Disease Characteristics

Other:

  • At least 1 month since prior adjuvant therapy for melanoma
  • At least 1 month since other prior therapy for melanoma
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006113

Locations
United States, California
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089
Sponsors and Collaborators
University of Southern California
Investigators
Study Chair: Jeffrey S. Weber, MD, PhD University of Southern California
  More Information

No publications provided

Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT00006113     History of Changes
Other Study ID Numbers: CDR0000068125 (10M-99-1), LAC-USC-10M991, NCI-G00-1837, NCI-T99-0102
Study First Received: August 3, 2000
Last Updated: October 20, 2012
Health Authority: United States: Federal Government

Keywords provided by University of Southern California:
stage III melanoma
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
Interferon-gamma
Interferons
Aldesleukin
Interleukin-4
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents
Antirheumatic Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Anti-HIV Agents
Anti-Retroviral Agents

ClinicalTrials.gov processed this record on April 17, 2014