Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Vaccine Therapy in Treating Patients With Stage IV or Recurrent Malignant Melanoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Closed	Over 18	NCI	UCLA-9707074 NCI-G02-2077, NCT00039325

Objectives

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

Entry 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

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

Patient Characteristics:

Age:

• Over 18

Performance status:

• Karnofsky 70-100%

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count greater than 1,000/mm³
• WBC greater than 3,000/mm³
• Hemoglobin greater than 9.0 g/dL
• Platelet count greater than 100,000/mm³

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

Expected Enrollment

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

Outcomes

Optimal dose

Toxicity
Immunological response (peptide-specific T cell generation, skin test immunohistology)
Clinical response

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.

Trial Contact Information

Trial Lead Organizations

Jonsson Comprehensive Cancer Center at UCLA

James Economou, MD, Protocol chair		Ph: 310-794-6913; 888-798-0719

Registry Information
Official Title		A Phase I/II Trial Testing Mart-1 Genetic Immunization In Malignant Melanoma
Trial Start Date		2002-03-13
Registered in ClinicalTrials.gov		NCT00039325
Date Submitted to PDQ		2002-04-03
Information Last Verified		2006-04-11
NCI Grant/Contract Number		CA16042, CA79976

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