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Dendritic Cell Immunotherapy of Metastatic Melanoma - A Phase I Trial

Phase 1
18 Years
80 Years
Not Enrolling
Melanoma (Skin)

Thank you

Trial Information

Dendritic Cell Immunotherapy of Metastatic Melanoma - A Phase I Trial

OBJECTIVES: I. Determine the safety and tolerability of antigen pulsed dendritic cell
therapy in patients with metastatic melanoma. II. Perform serial analysis of T cell and B
cell function in these patients after this treatment. III. Determine objective response and
response duration in these patients after this treatment.

OUTLINE: Patients receive filgrastim (G-CSF) subcutaneously (SQ) on days 1-6, then undergo
leukapheresis for 2-3 days, beginning on day 6. Mononuclear cells are selected for CD34+
cells in the laboratory, made into dendritic cells, and then pulsed with MART-1, gp100,
tyrosinase, MAGE-3 peptides and flu matrix. These antigen pulsed dendritic cells (ApDCs) are
used for vaccinations. Prior to vaccination, ApDCs are mixed with MART-1, gp100, tyrosinase,
MAGE-3, and flu matrix. Patients receive this dendritic cell vaccine mixture SQ every 2
weeks for 4 priming doses. Patients receive 4 boost vaccinations SQ at 2 months, 5 months, 9
months, and 15 months following the last priming vaccination. Patients are followed monthly
for 2 years.

PROJECTED ACCRUAL: A total of 28 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven metastatic melanoma Measurable disease
HLA-A2 01 phenotype No active CNS or hepatic metastases

PATIENT CHARACTERISTICS: Age: 18 to 80 Performance status: Karnofsky 80-100% Life
expectancy: Not specified Hematopoietic: Normal CD4 and CD8 T cell numbers by flow
cytometry Lactic dehydrogenase less than 2 times normal Hepatic: No viral hepatitis Renal:
Not specified Cardiovascular: No prior venous thrombosis, angina pectoris, or congestive
heart failure Pulmonary: No prior asthma Immunologic: Positive intradermal skin test for
mumps, histoplasmosis, or streptokinase antigen Immunoglobulin levels normal No prior
autoimmune disease (lupus erythematosus, rheumatoid arthritis, or thyroiditis) No allergy
to tetanus toxoid or influenza vaccine No sensitivity to E. coli drug preparations Other:
Not pregnant or nursing Fertile patients must use effective contraception HIV negative No
active infection

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior interferon At
least 8 weeks since prior interleukin-2 Chemotherapy: No more than 3 prior courses of
cytotoxic chemotherapy At least 8 weeks since prior chemotherapy Endocrine therapy: No
concurrent corticosteroids Radiotherapy: Not specified Surgery: Not specified Other: No
other concurrent immunosuppressive agents

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Joseph W. Fay, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Baylor Health Care System


United States: Federal Government

Study ID:




Start Date:

April 1999

Completion Date:

October 2006

Related Keywords:

  • Melanoma (Skin)
  • stage IV melanoma
  • recurrent melanoma
  • Melanoma



Baylor University Medical Center Dallas, Texas  75246