NCT01232712已完成1 期
A Novel Vaccine for the Treatment of MUC1-expressing Tumor Malignancies
Vaxil Therapeutics Ltd.1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2010年9月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Safety of intradermal or subcutaneous administration of the ImMucin peptide
研究概览
简要总结
The scientific approach behind this study is to develop novel anti-cancer therapeutic vaccine to induce a robust cellular immune response mediated via both CD4+ and CD8+ T lymphocytes populations and can be be applicable to the majority of the target population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •All* patients must have a histological or cytological diagnosis of metastatic disease or hematological malignancies expressing the MUC
- •Patients must have metastatic disease, and have failed at least one regimen of standard based chemotherapy for metastatic disease as indicated in the following table. Patients must have disease considered to be incurable by surgical or radiological intervention.
- •Patients must be > 18 years of age, consenting to participate in the study.
- •Patients must have at least one site of measurable tumor or measurable tumor marker.
- •Radiological and other relevant imaging studies, such as CT scans, must be performed within 4 weeks of the first treatment as a baseline to document extent of disease.
- •Patients should be at least 4 weeks beyond any major surgery or chemoradiotherapy and have recovered from drug induced toxicity.
- •Patients must have a performance status of 70% or greater on the Karnofsky scale (ECOG 0-2) and a minimal life expectancy of 12 months.
- •Patients must sign an informed consent, and be mentally responsible.
- •In Multiple Myeloma, MUC1 expression will be tested after confirming that all inclusion/
排除标准
- •are met and within the screening period.
- •Exclusion Criteria:
- •Patients not fulfilling the above criteria.
- •Patients with a significant concurrent medical complication that in the judgment of the Principal Investigator could affect the patient's ability to tolerate or complete this study.
- •Patients receiving any immunosuppressive treatment that could negate development of an effective immune response to the vaccine. (First vaccination should be at least 30 days from end of immunosuppressive treatment)
- •Subjects with prior irradiation to a field that includes more than 25% of their lymph nodes and bone marrow likely to be immunosuppressed will be excluded. However, patients who had standard pelvic field radiation as adjuvant therapy for rectal cancer are not excluded.
- •Pregnant and breast feeding women will be excluded. Premenopausal women who are not practicing or willing to practice adequate birth control methods for a period of 3 months after treatment will be excluded.
- •Patients with brain metastasis.
- •Patients with active infection.
- •Patients with HIV HBSAg and HCV positive.
结局指标
主要结局
Safety of intradermal or subcutaneous administration of the ImMucin peptide
时间窗: 6 months
Determine the safety and initial feasibility of intradermal or subcutaneous administration of the ImMucin peptide combined with hGM-CSF for maximal stimulation of T cell response. The patients will receive six or twelve biweekly injections of Imucin (3 or 6 months). Post Treatment visit will be performed 4 weeks after administration of last vaccination. FU telephone calls will be made up to 6 months following the last vaccination in order to assess the status of the disease.
次要结局
- Assess efficacy of study treatment(6 months)
研究者
研究点 (1)
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