Peptide Vaccine With Glucopyranosyl Lipid A - Stable Oil-in-Water Emulsion (GLA-SE) for Patients With Resected Melanoma: A Pilot Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Immune response
研究概览
简要总结
This randomized pilot clinical trial studies melanoma antigen recognized by T-cells 1 (MART-1) antigen with or without toll-like receptor 4 (TLR4) agonist glucopyranosyl lipid A-stable oil-in-water emulsion (GLA-SE) in treating patients with stage II-IV melanoma that has been removed by surgery. Vaccines made from MART-1a peptide or antigen may help the body build an effective immune response to kill tumor cells. Giving TLR4 agonist GLA-SE with MART-1 antigen may help increase the immune response to MART-1a antigen.
详细描述
PRIMARY OBJECTIVES:
I. Evaluate the immune response of each immunization regimen to determine an optimal regimen in terms of immune response to recommend for phase II testing.
SECONDARY OBJECTIVES:
I. Evaluate the adverse events profile of each immunization regimen.
TERTIARY OBJECTIVES:
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
- •Central pathology review submission; Note: this review for MART-1 positivity is mandatory prior to randomization to confirm eligibility
- •Human leukocyte antigen (HLA)-A2-positive
- •Histologic proof of stage II, III or IV melanoma that has been completely resected or completely treated with ablative therapy (ex: stereotactic body radiosurgery, radiofrequency ablation, cryoablation) with no current evidence of disease, as demonstrated by imaging within 2 months (stage III or stage IV; must be computed tomography [CT], magnetic resonance imaging [MRI], or positron emission tomography [PET]/CT) or 6 months (stage II; may be chest x-ray, CT, MRI, or PET/CT)
- •Absolute neutrophil count (ANC) >= 1500 mL
- •Hemoglobin (Hgb) > 10 g/dL
- •Platelets (PLT) >= 50,000 mL
- •Aspartate aminotransferase (AST) =< 3 x upper limit of normal (ULN)
- •Alkaline phosphatase =< 3 x ULN
- •Ability to provide informed consent
- •Willingness to return to Mayo Clinic Rochester for follow-up
- •Life expectancy >= 12 weeks
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
- •For women of childbearing potential, a negative serum pregnancy test =< 7 days prior to registration
- •Willingness to provide mandatory blood samples for correlative research
排除标准
- •Uncontrolled or current infection
- •Known standard therapy for the patient's disease that is potentially curative or proven capable of extending life expectancy
- •Known allergy to any of the vaccine or adjuvant components, including eggs
- •Any of the following prior therapies with interval since most recent treatment:
- •Chemotherapy =< 4 weeks prior to registration
- •Biologic or immunologic therapy =< 4 weeks prior to registration
- •Radiation therapy =< 4 weeks prior to registration
- •Failure to fully recover from side effects of prior therapy or surgery
- •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.)
- •Known immune deficiency, including human immunodeficiency virus (HIV) infection
- •History of systemic autoimmune disease, as patients with ongoing autoimmunity may be at an increased risk of autoimmune toxicity from the study vaccine
- •Current or recent (=< 4 weeks) use of immunosuppressive medications including systemic (inhaled, oral, or intravenous [IV]) corticosteroids; Note: use of corticosteroids in doses not exceeding those used for adrenal replacement is acceptable
- •History of brain metastases; EXCEPTION: patients with a solitary brain metastasis that has been completely resected, and who have no ongoing central nervous system (CNS) symptoms and an MRI documenting no evidence of CNS disease at least 3 months after resection and within 30 days of registration, are eligible for treatment
- •Other active malignancy =< 5 years prior to registration; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: if there is a history of prior malignancy > 5 years prior to registration, the patient must not be receiving other cancer treatment
研究组 & 干预措施
Arm I (MART-1 antigen and TLR4 antagonist GLA-SE)
Patients receive MART-1 antigen and TLR4 antagonist GLA-SE IM on day 1. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
干预措施: MART-1 Antigen (Biological)
Arm I (MART-1 antigen and TLR4 antagonist GLA-SE)
Patients receive MART-1 antigen and TLR4 antagonist GLA-SE IM on day 1. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
干预措施: TLR4 Agonist GLA-SE (Drug)
Arm I (MART-1 antigen and TLR4 antagonist GLA-SE)
Patients receive MART-1 antigen and TLR4 antagonist GLA-SE IM on day 1. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
干预措施: Laboratory Biomarker Analysis (Other)
Arm II (MART-1 antigen)
Patients receive MART-1 antigen IM on day 1. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
干预措施: MART-1 Antigen (Biological)
Arm II (MART-1 antigen)
Patients receive MART-1 antigen IM on day 1. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
干预措施: Laboratory Biomarker Analysis (Other)
结局指标
主要结局
Immune response
时间窗: Up to 24 months
A patient is considered to have achieved an immune response if there is a 2-fold or more increase from pre-treatment levels in the absolute number of vaccine peptide-specific (MART-1a-specific) CTL as measured by tetramer staining, or if the frequency of MART-1a-specific CTL is initially undetectable (\< 0.05% of CD8 T cells) and becomes detectable during the vaccine treatment period. The proportion of successes will be estimated and the exact binomial 95% confidence intervals for the true immune response rate will be calculated.
次要结局
- Adverse event rate, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0(Up to 24 months)