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Mature Dendritic Cell Immunotherapy Of Metastatic Melanoma- A Phase I Trial


Phase 1
21 Years
N/A
Open (Enrolling)
Both
Melanoma (Skin)

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Trial Information

Mature Dendritic Cell Immunotherapy Of Metastatic Melanoma- A Phase I Trial


OBJECTIVES:

- Determine the safety and tolerability of antigen-pulsed dendritic cell vaccine in
patients with metastatic melanoma.

- Determine the longevity of melanoma-specific immunity in patients treated with this
regimen.

- Perform serial analysis of T-cell and B-cell function in patients treated with this
regimen.

OUTLINE: Patients receive filgrastim (G-CSF) subcutaneously (SC) once daily on days 1-6 or
1-7. Patients undergo apheresis on days 6 and 7 or 6-8 to obtain peripheral blood
mononuclear cells (PBMC). PBMC are processed for CD34+ cell isolation. These autologous
CD34+ hematopoietic progenitor cells are cultured to generate dendritic cells (DC). DC are
then pulsed with endotoxin-free keyhole limpet hemocyanin and HLA-A2-01 restricted
flu-matrix peptides derived from melanoma-associated tumor antigens (MART-1:27-35,
gp100:209-217, and MAGE-3). Antigen-pulsed DC are incubated with interferon alfa to induce
DC maturation.

Patients receive priming injections of antigen-pulsed DC vaccine SC once every 2 weeks for 8
weeks. Treatment repeats at 2, 3, 4, and 5 months after the last priming injection in the
absence of unacceptable toxicity or disease progression.

Patients are followed at 2 and 4 weeks and then every 3 months for 1.5 years.

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

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed metastatic melanoma

- HLA-A2-01 phenotype

- Measurable disease

- No active CNS or hepatic metastases

PATIENT CHARACTERISTICS:

Age:

- 21 and over

Performance status:

- Karnofsky 80-100%

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- See Disease Characteristics

- No viral hepatitis

Renal:

- Not specified

Cardiovascular:

- No prior venous thrombosis, angina pectoris, or congestive heart failure

- Lactate dehydrogenase less than 2 times normal

Pulmonary:

- No prior asthma

Immunologic:

- Intradermal skin test positivity to mumps, Candida, or streptokinase antigen

- No known sensitivity to E. coli drug preparations

- No prior allergy to influenza vaccine

- No active infection

- No prior autoimmune disease (e.g., lupus erythematosus, rheumatoid arthritis, or
thyroiditis)

Other:

- HIV negative

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 8 weeks since prior interleukin-2

- At least 4 weeks since prior interferon alfa

Chemotherapy:

- At least 8 weeks since prior chemotherapy

Endocrine therapy:

- At least 2 weeks since prior corticosteroids

- No concurrent corticosteroids

Radiotherapy:

- Not specified

Surgery:

- Not specified

Other:

- No concurrent immunosuppressive agents

- At least 2 weeks since prior immunosuppressive agents

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Joseph W. Fay, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Baylor Health Care System

Authority:

United States: Federal Government

Study ID:

CDR0000068680

NCT ID:

NCT00017355

Start Date:

April 2001

Completion Date:

Related Keywords:

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

Name

Location

Baylor University Medical CenterDallas, Texas  75246