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Vaccine Therapy Followed by Biological Therapy in Treating Patients With Stage III or Stage IV Melanoma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2003 by National Cancer Institute (NCI).   Recruitment status was  Active, not recruiting

First Received on August 3, 2000.   Last Updated on February 6, 2009   History of Changes
Sponsor: USC/Norris Comprehensive Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006113
  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 II

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 National Cancer Institute (NCI):

Study Start Date: June 1999
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
USC/Norris Comprehensive Cancer Center
Investigators
Study Chair: Jeffrey S. Weber, MD, PhD USC/Norris Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00006113     History of Changes
Other Study ID Numbers: CDR0000068125, LAC-USC-10M991, NCI-G00-1837, NCI-T99-0102
Study First Received: August 3, 2000
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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
Interferon-gamma, Recombinant
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 February 09, 2012