Melanoma Vaccines: Differentiation Antigen Peptides (MART-1:27-35, Tyrosinase and Gp-100) as Immune Targets
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Changes in tumor antigen peptide specific immune responses
研究概览
简要总结
This randomized pilot clinical trial studies vaccine therapy and sargramostim in treating patients with stage IV malignant melanoma. Vaccines made from melanoma peptides or antigens may help the body build an effective immune response to kill tumor cells. Colony-stimulating factors, such as sargramostim, increase the number of white blood cells and platelets found in bone marrow or peripheral blood. Giving vaccine therapy together with sargramostim may be an effective treatment for malignant melanoma
详细描述
PRIMARY OBJECTIVES:
I. Determine the immunological effects of immunization protocols utilizing MART-1:27-35 (MART-1:27-35 peptide vaccine), tyrosinase (tyrosinase peptide) or gp-100 (gp100 antigen) peptides suspended in incomplete Freund's adjuvant (IFA) in the presence of two different concentrations of sargramostim (GM-CSF).
II. Define the safety and toxicity profile of an immunization protocol utilizing varying concentrations of MART-1:27-35, tyrosinase and gp-100 peptides suspended in IFA in the presence of two different concentrations of GM-CSF.
III. Collect preliminary data on therapeutic efficacy as it relates to parameters of immune function in patients with stage IV malignant melanoma.
OUTLINE: Patients are randomized to 1 of 3 treatment arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Human leukocyte antigen (HLA)-A2 positive
- •Histologic proof of stage IV malignant melanoma with measurable disease
- •Absolute neutrophil count (ANC) >= 1500
- •Platelets (PLT) >= 100,000
- •Alkaline phosphatase (Alk phos) =< 3 x upper limit of normal (ULN)
- •Aspartate aminotransferase (AST) =< 3 x ULN
- •Creatinine (Creat) =< 1.5 x ULN
- •Hemoglobin (Hgb) > 9.0
- •Ability to provide informed consent
- •Willingness to return to a Mayo Clinic institution for follow-up
- •Life expectancy >= 12 weeks
- •Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
排除标准
- •Uncontrolled or current infection
- •Prior immunization with differentiation antigen peptides
- •Known standard therapy for the patient's disease that is potentially curative or proven capable of extending life expectancy
- •Any of the following prior therapies:
- •Chemotherapy =< 4 weeks
- •Mitomycin C/nitrosoureas =< 6 weeks
- •Immunotherapy =<4 weeks
- •Biologic therapy =< 4 weeks
- •Radiation therapy =< 4 weeks
- •Radiation to > 25% of bone marrow
- •Failure to fully recover from effects of prior chemotherapy regardless of interval since last treatment
- •New York Heart Association classification III or IV
- •Seizure disorder
- •Any of the following:
- •Pregnant women
- •Nursing women
- •Women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.)
- •Other concurrent chemotherapy, immunotherapy, or radiotherapy
- •Active psychiatric disorder requiring medications (anti-psychotics)
- •Known central nervous system metastases or carcinomatous meningitis
- •History of other malignancy in last 5 years with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only (it is impossible to predict the effect of study treatment on other, potentially dormant malignant diseases)
- •Known immune deficiency (patients with known immune deficiencies will likely not be able to mount an immune response to the study vaccine)
结局指标
主要结局
Changes in tumor antigen peptide specific immune responses
时间窗: Baseline and 24 weeks
Plots of the percent changes in these factors from their pretreatment levels against time will be constructed.
次要结局
- Number and severity of hematologic and non-hematologic toxicities observed using the Common Toxicity Criteria (CTC) version 2.0(Up to 3 years)
- Proportion of objective responses (complete response [CR] and partial response [PR]) observed(Up to 3 years)