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Vaccine Therapy in Treating Patients With Stage IV or Relapsed Malignant Melanoma
This study is ongoing, but not recruiting participants.
Study NCT00005617   Information provided by National Cancer Institute (NCI)
First Received: May 2, 2000   Last Updated: February 6, 2009   History of Changes

May 2, 2000
February 6, 2009
July 1997
 
 
 
Complete list of historical versions of study NCT00005617 on ClinicalTrials.gov Archive Site
 
 
 
Vaccine Therapy in Treating Patients With Stage IV or Relapsed Malignant Melanoma
A Phase I Trial Testing Mart-1 Peptide Immunization in Malignant Melanoma

RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients who have stage IV, or relapsed malignant melanoma.

OBJECTIVES:

  • Determine the safety of administering MART-1 peptide-pulsed dendritic cells to patients with stage IV or relapsed malignant melanoma.
  • Determine the immunological and clinical responses in this patient population after this therapy.

OUTLINE: This is a dose-escalation study.

Patients undergo leukapheresis between days -14 to -8. Mononuclear cells are isolated, used to generate dendritic cells (DC), and then pulsed with MART-1 peptide. Patients are vaccinated with MART-1 peptide-pulsed DC either IV or intradermally on days 0, 14, and 28.

Cohorts of 3-6 patients receive escalating doses of MART-1 peptide-pulsed DC until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

Patients are followed until death.

PROJECTED ACCRUAL: A total of 18-24 patients will be accrued for this study.

Phase I, Phase II
Interventional
Treatment
Melanoma (Skin)
  • Biological: dendritic cell-MART-1 peptide vaccine
  • Procedure: in vitro-treated peripheral blood stem cell transplantation
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

DISEASE CHARACTERISTICS:

  • Histologically confirmed malignant melanoma

    • Stage IV or relapsed
  • HLA-A2.1-positive and MART-1 expression determined by reverse transcriptase-polymerase chain reaction or immunohistochemistry
  • No uncontrolled CNS metastasis

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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • Not specified

Hematopoietic:

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

Hepatic:

  • Not specified

Renal:

  • Not specified

Cardiovascular:

  • No prior evidence of New York Heart Association class III or IV heart disease

Pulmonary:

  • No acute lung disease that would preclude anesthesia or surgery
  • No dyspnea at rest

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No prior evidence of opportunistic infection
  • No acute viral, bacterial, or fungal infection requiring specific therapy within the past 14 days
  • No acute medical problems that may be considered an unacceptable anesthetic or operative risk
  • No underlying condition that would preclude study therapy
  • No allergies to study reagents
  • No organ allografts
  • Positive skin test to common antigens (i.e., tetanus and Candida)
  • HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 30 days since prior immunotherapy

Chemotherapy:

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

Endocrine therapy:

  • No concurrent corticosteroids

Radiotherapy:

  • At least 30 days since prior radiotherapy

Surgery:

  • At least 30 days since prior surgery

Other:

  • No concurrent cyclosporine
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00005617
 
CDR0000067754, UCLA-9508375, NCI-H00-0050
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: James S. Economou, MD Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
April 2003

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