Mature Dendritic Cell Immunotherapy Of Metastatic Melanoma- A Phase I Trial
21 Years
N/A
Both
Melanoma (Skin)
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 Center | Dallas, Texas 75246 |
