Vaccine Therapy in Treating Patients With Metastatic Melanoma
关键词
抽象
描述
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.
日期
| 最后验证: | 04/30/2014 |
| 首次提交: | 06/06/2006 |
| 提交的预估入学人数: | 06/06/2006 |
| 首次发布: | 06/07/2006 |
| 上次提交的更新: | 05/18/2014 |
| 最近更新发布: | 05/20/2014 |
| 实际学习开始日期: | 09/30/2003 |
| 预计主要完成日期: | 05/31/2005 |
| 预计完成日期: | 05/31/2005 |
状况或疾病
干预/治疗
Biological: MART-1 antigen
Biological: gp100:209-217(210M) peptide vaccine
Biological: therapeutic autologous dendritic cells
Biological: tyrosinase peptide
相
资格标准
| 有资格学习的年龄 | 16 Years 至 16 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | 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 |
结果
主要结果指标
1. Overall survival [undefined]
2. Progression-free survival [undefined]
3. Time to progression [undefined]
4. Toxicity [undefined]
