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

August 3, 2000
October 20, 2012
June 1999
May 2003   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00006113 on ClinicalTrials.gov Archive Site
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Vaccine Therapy Followed by Biological Therapy in Treating Patients With Stage III or Stage IV Melanoma
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

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.

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.

Interventional
Phase 2
Primary Purpose: Treatment
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
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
25
April 2006
May 2003   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006113
CDR0000068125 (10M-99-1), LAC-USC-10M991, NCI-G00-1837, NCI-T99-0102
Yes
University of Southern California
University of Southern California
National Cancer Institute (NCI)
Study Chair: Jeffrey S. Weber, MD, PhD University of Southern California
University of Southern California
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP