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Vaccine Therapy in Treating Patients With Stage IV or Recurrent Malignant Melanoma
This study is ongoing, but not recruiting participants.
First Received: June 6, 2002   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00039325
  Purpose

RATIONALE: Vaccines made by inserting a laboratory-treated gene into a person's white blood cells may make the body build an immune response to kill tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of vaccine therapy and to see how well it works in treating patients with stage IV or recurrent malignant melanoma.


Condition Intervention Phase
Melanoma (Skin)
Biological: dendritic cell-MART-1 peptide vaccine
Phase I
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: A Phase I/II Trial Testing Mart-1 Genetic Immunization In Malignant Melanoma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Optimal dose [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Designated as safety issue: Yes ]
  • Immunological response (peptide-specific T cell generation, skin test immunohistology) [ Designated as safety issue: No ]
  • Clinical response [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: March 2002
Detailed Description:

OBJECTIVES:

  • Determine the safety of vaccination with MART-1 adenovirus-transduced dendritic cells in patients with stage IV or recurrent malignant melanoma.
  • Determine the immunological and clinical responses of patients receiving this vaccine.

OUTLINE: This is a dose-escalation study.

Patients undergo leukapheresis. Mononuclear cells are isolated and dendritic cells (DC) are generated. DC are incubated with the adenoviral vector containing MART-1. Patients receive MART-1 adenovirus-transduced dendritic cell (AdVMART1/DC) vaccine intradermally on days 0, 14, and 28. Patients with a significant clinical or immunological response are eligible for 6 additional monthly vaccinations.

Cohorts of 3-6 patients receive escalating doses of the AdVMART1/DC vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed on weeks 1, 4, and 12 and then for survival.

PROJECTED ACCRUAL: A total of 6-36 patients will be accrued for this study.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed stage IV or recurrent malignant melanoma
  • HLA-A2.1 and/or HLA-DR4 positive and MART-1 expression determined by reverse transcription polymerase chain reaction or immunohistochemistry
  • No uncontrolled CNS metastases

    • CNS metastases allowed if treated with CNS irradiation to control local tumor growth

PATIENT CHARACTERISTICS:

Age:

  • Over 18

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count greater than 1,000/mm^3
  • WBC greater than 3,000/mm^3
  • Hemoglobin greater than 9.0 g/dL
  • Platelet count greater than 100,000/mm^3

Hepatic:

  • Not specified

Renal:

  • Not specified

Cardiovascular:

  • No prior evidence of New York Heart Association class III-IV cardiac insufficiency
  • No coronary artery disease
  • No acute ischemic heart disease that would preclude anesthesia or surgery

Pulmonary:

  • No acute lung disease that would preclude anesthesia or surgery

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Positive skin test to common antigens (e.g., tetanus and/or Candida)
  • HIV negative
  • No prior evidence of opportunistic infection
  • No prior clinical evidence of autoimmune disease
  • No other underlying condition that would preclude study participation
  • No allergies to study reagents
  • No other acute medical problem that would preclude anesthesia or surgery

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 30 days since prior immunotherapy for melanoma

Chemotherapy:

  • At least 30 days since prior chemotherapy for melanoma
  • No concurrent chemotherapy

Endocrine therapy:

  • No concurrent corticosteroids

Radiotherapy:

  • See Disease Characteristics
  • At least 30 days since prior radiotherapy for melanoma

Surgery:

  • More than 30 days since prior surgery for melanoma
  • No prior organ allograft

Other:

  • At least 14 days since prior therapy for any acute viral, bacterial, or fungal infection
  • No concurrent specific therapy for any acute viral, bacterial, or fungal infection
  • No concurrent cyclosporine
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00039325

Locations
United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Study Chair: James S. Economou, MD Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000069373, UCLA-9707074, NCI-G02-2077
Study First Received: June 6, 2002
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00039325     History of Changes
Health Authority: United States: Federal Government

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

Study placed in the following topic categories:
Neuroectodermal Tumors
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Nevus
Recurrence
Neuroendocrine Tumors
Melanoma

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

ClinicalTrials.gov processed this record on July 02, 2009