Vaccine Therapy in Treating Patients With Metastatic Melanoma
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Purpose
RATIONALE: Vaccines made from a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill melanoma cells.
PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with metastatic melanoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Intraocular Melanoma Melanoma (Skin) |
Biological: MART-1 antigen Biological: gp100:209-217(210M) peptide vaccine Biological: therapeutic autologous dendritic cells Biological: tyrosinase peptide |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of an Intradermally Administered MART-1gp100/Tyrosinase Peptide-Pulsed Dendritic Cell Vaccine Matured With a Cytokine Cocktail for Patients With Metastatic Melanoma |
- Overall survival [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Time to progression [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 41 |
| Study Start Date: | October 2003 |
| Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
- Determine clinical response in HLA-A *0201-positive patients with metastatic melanoma treated with an intradermally administered vaccine comprising autologous dendritic cells pulsed with MART-1, gp100, and tyrosinase peptides and matured with a cytokine cocktail.
Secondary
- Determine immunologic response in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients undergo apheresis to collect dendritic cells (DC). Autologous DC are pulsed ex vivo with tumor antigen peptides derived from MART-1: 26-35 (27L), gp100: 209-217 (210M), and tyrosinase: 368-376 (370D) and matured with a cytokine cocktail comprising interleukin (IL)-4, IL-6, IL-1β, sargramostim (GM-CSF), tumor necrosis factor-α, and prostaglandin E2.
Patients receive 12 intradermal injections of DC vaccine over 30 minutes on days 1, 8, 22, and 36. Treatment repeats every 8 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically until disease progression.
PROJECTED ACCRUAL: A total of 41 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of melanoma
- Metastatic disease
The following melanoma subtypes are eligible:
- Unresectable, stage III-IV uveal melanoma
- Metastatic mucosal melanoma
- Measurable disease after attempted curative surgical therapy
Tumor tissue must be available for immunohistochemical staining
Positive for ≥ 1 of the following peptides:
- MART-1: 26-35 (27L)
- gp100: 209-217 (210M)
- Tyrosinase: 368-376 (370D)
- HLA-A *0201 positive by DNA polymerase chain reaction assay
PATIENT CHARACTERISTICS:
- ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%
- Creatinine ≤ 2.0 mg/dL
- Bilirubin ≤ 2.0 mg/dL
- WBC ≥ 3,000/mm^3
- Platelet count ≥ 75,000/mm^3
- Hemoglobin ≥ 9.0 g/dL
- No major systemic infections
- No coagulation disorders
- No major medical illness of the cardiovascular or respiratory system
- No myocardial infarction within the past 6 months
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No known HIV positivity
- No know positivity for hepatitis B surface antigen or hepatitis C antibody
- No prior uveitis or autoimmune inflammatory eye disease
- No other prior malignancy except cervical carcinoma in situ or basal cell skin cancer unless patient was curatively treated > 5 years ago and has no detectable disease
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No more than 1 prior cytotoxic chemotherapy agent or regimen
- Prior biologic or antiangiogenic therapies allowed
- More than 1 month since prior and no concurrent radiotherapy, chemotherapy, adjuvant therapy, or any other therapy for melanoma
- No prior MART-1: 26-35 (27L), gp100: 209-217 (210M), or tyrosinase: 368-376 (370D) peptides
- No concurrent steroid therapy
Contacts and Locations| United States, California | |
| USC/Norris Comprehensive Cancer Center and Hospital | |
| Los Angeles, California, United States, 90089-9181 | |
| United States, Michigan | |
| University of Michigan Comprehensive Cancer Center | |
| Ann Arbor, Michigan, United States, 48109-0942 | |
| Study Chair: | Jeffrey S. Weber, MD, PhD | USC/Norris Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00334776 History of Changes |
| Other Study ID Numbers: | CDR0000480137, LAC-USC-10M-03-1, NCI-6262, LAC-USC-033307 |
| Study First Received: | June 7, 2006 |
| Last Updated: | May 13, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
recurrent melanoma stage IV melanoma ciliary body and choroid melanoma, medium/large size |
iris melanoma recurrent intraocular melanoma extraocular extension melanoma |
Additional relevant MeSH terms:
|
Melanoma Uveal Neoplasms Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms |
Neoplasms, Nerve Tissue Nevi and Melanomas Eye Neoplasms Neoplasms by Site Eye Diseases Uveal Diseases |
ClinicalTrials.gov processed this record on October 16, 2012
