Vaccine Therapy in Treating Patients With Stage IV or Recurrent Malignant Melanoma - Full Text View

Sponsor:	Jonsson Comprehensive Cancer Center
Collaborator:	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:

MedlinePlus related topics: Cancer Melanoma

U.S. FDA Resources

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

National Cancer Institute (NCI)

Investigators

Study Chair:

James S. Economou, MD

Jonsson Comprehensive Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

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

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 February 08, 2010