Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Closed	Over 18	NCI, Other	CDR0000069373 UCLA-9707074, NCI-G02-2077, NCT00039325

Trial Description

Summary

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.

Further Study Information

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 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Jonsson Comprehensive Cancer Center at UCLA

James S. Economou

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00039325
Information obtained from ClinicalTrials.gov on October 19, 2009

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