Melanoma |
Melanoma cancer |
Clinical Trial: Vaccine Therapy in Treating Patients With Metastatic Melanoma
This study is no longer recruiting patients.
Purpose
RATIONALE: Vaccines made from a patient's white blood cells mixed with tumor antigens may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic melanoma.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Stage IV Melanoma Recurrent Melanoma | Drug: autologous dendritic cells Drug: filgrastim Procedure: biological response modifier therapy Procedure: colony-stimulating factor therapy Procedure: cytokine therapy Procedure: non-tumor cell derivative vaccine Procedure: vaccine therapy | Phase I |
MedlinePlus related topics: Melanoma
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Study of Antigen-Pulsed Dendritic Cell Vaccine in Patients With Metastatic Melanoma
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.
Eligibility
Ages Eligible for Study: 21 Years and above, Genders Eligible for Study: Both
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
Location Information
Texas
Baylor University Medical Center, Dallas, Texas, 75246, United States
Joseph Wayne Fay, MD, Study Chair, Baylor University
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: April 2003
Last Updated: October 13, 2004
Record first received: June 6, 2001
ClinicalTrials.gov Identifier: NCT00017355
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- "Hidden" Melanomas (American Academy of Dermatology)
- ABCDs of Melanoma Detection (American Academy of Dermatology)

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