NCT00660101Unknown1 期
OVax®: A Feasibility Study Using a DNP-Modified Autologous Ovarian Tumor Cell Vaccine as Therapy in Ovarian Cancer Patients After Relapse:
AVAX Technologies6 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2008年6月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 34
- 试验地点
- 6
- 主要终点
- Cell-mediated immunity to autologous tumor cells
研究概览
简要总结
To determine if a vaccine made from the patient's own tumor tissue can stimulate an immune response against the patient's tumor cells. To determine the safety of the vaccine.
详细描述
To study the toxicity, safety and DTH response of DNP-modified autologous ovarian tumor cell vaccine and the DTH response to unmodified ovarian tumor cells in patients with relapsed ovarian cancer:
- To determine the tolerability and toxicity of the treatment regimen
- To determine whether O-Vax induces a DTH response to autologous, DNP-modified ovarian cancer cells
- To determine whether O-Vax induces a DTH response to autologous, unmodified ovarian cancer cells
Study Population: Patients with recurrent epithelial ovarian cancer whose therapeutic tumor surgery provides a mass which yields adequate tumor cells for vaccine preparation and delayed-type hypersensitivity (DTH) testing
Study Design: A Phase I/IIa double-blind, three-dose, multi-center study
Investigational Product: O-Vax: DNP-modified autologous ovarian tumor cell vaccine
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Screening Phase
- •Stage III or IV adenocarcinoma of ovary
- •Candidate for surgery to excise the tumor
- •Signed informed consent for tumor acquisition
- •Treatment Phase
- •At least 18 years of age
- •Standard surgical debulking to maximum extent possible
- •Adequate amount of tumor tissue obtained from surgical debulking to prepare a series of vaccines and skin test materials.
- •Administration of intraperitoneal chemotherapy following surgical debulking Intraperitoneal drug to consist of a taxane (paclitaxel or docetaxel) Dose of taxane: paclitaxel=60-75 mg/m2 / weekly x 4 or docetaxel = 25 mg/m2 - weekly x 4
- •Vaccines and DTH materials pass lot release
- •Minimum of 2 weeks and maximum of 6 weeks following last dose of intraperitoneal chemotherapy
- •Immunocompetent, as determined by anergy panel performed 1 week after last dose of intraperitoneal chemotherapy (baseline PPD+ patients allowed)
- •Expected survival of at least 6 months
- •Karnofsky performance status ³ 80
- •Signed informed consent for protocol participation
排除标准
- •Alkaline phosphatase > 2.5 x ULN
- •Total bilirubin > 2.0 mg/dL
- •Creatinine > 2.0 mg/dL
- •Hemoglobin < 10.0 g/dL
- •WBC < 3,000 /mm3
- •Platelet count < 100,000/mm3
- •Major field radiotherapy within 6 months prior to participation in the study
- •Brain metastases, unless successfully treated at least 6 months prior to entry
- •Prior immunotherapy (interferons, tumor necrosis factor, other cytokines [e.g., interleukins], biological response modifiers, or monoclonal antibodies) within 4 weeks prior to participation in the study
- •Prior splenectomy
- •Concurrent use of systemic steroids (Note: Topical steroid therapies [applied to the skin] are not contraindicated for participation in the study, provided these are not applied to either arm. Inhaled aerosol steroids are not contraindicated for participation in the study.)
- •Concurrent use of immunosuppressive drugs
- •Concurrent use of antitubercular drugs (isoniazid, rifampin, streptomycin)
- •Other malignancy within 5 years except curatively treated non-melanomatous skin cancer and curatively treated carcinoma in situ of the uterine cervix
- •Concurrent autoimmune diseases, e.g., systemic lupus erythematosus, multiple sclerosis or ankylosing spondylitis
- •Concurrent medical condition that would preclude compliance or immunologic response to study treatment
- •Concurrent serious infection or other serious medical condition
- •Receipt of any investigational medication within 4 weeks prior to participation in the study
- •Known gentamicin sensitivity
- •Anergic, defined by the inability to make a DTH to at least one of the following: candida, mumps, tetanus, trichophyton (based upon availability), or PPD
- •Vaccine lot release failure
结局指标
主要结局
Cell-mediated immunity to autologous tumor cells
时间窗: 3 months
次要结局
- Safety(9 months)
研究者
研究点 (6)
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