Vaccine Therapy in Treating Patients With Metastatic Melanoma
NCT ID: NCT00017355
Last Updated: 2013-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
INTERVENTIONAL
2001-04-30
Brief Summary
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PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic melanoma.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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filgrastim
therapeutic autologous dendritic cells
Eligibility Criteria
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Inclusion Criteria
* 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
21 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Baylor Health Care System
OTHER
Principal Investigators
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Joseph W. Fay, MD
Role: STUDY_CHAIR
Baylor Health Care System
Locations
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Baylor University Medical Center
Dallas, Texas, United States
Countries
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Other Identifiers
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BAYUMC-000048
Identifier Type: -
Identifier Source: secondary_id
NCI-4170
Identifier Type: -
Identifier Source: secondary_id
CDR0000068680
Identifier Type: -
Identifier Source: org_study_id