NCT00058435已完成1 期
Phase I Trial of the Monoclonal Anti-Idiotype Antibody ACA125 in Patients With Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Vaccines made from monoclonal antibodies combined with tumor cells may make the body build an immune response to kill tumor cells.
PURPOSE: Randomized phase I trial to study the effectiveness of vaccine therapy in treating patients who have ovarian epithelial, fallopian tube, or peritoneal cancer.
详细描述
OBJECTIVES:
- Determine the safety of varying routes and doses of monoclonal antibody ACA125 anti-idiotype vaccine in patients with ovarian epithelial, fallopian tube, or peritoneal cancer.
- Determine an optimal dose and route of this vaccine for a phase II study.
- Determine the immune response induced by this vaccination in these patients.
- Determine the time to development of objective tumor response in patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 4 treatment arms.
- Arm I: Patients receive lower-dose monoclonal antibody ACA125 anti-idiotype vaccine (MOAB ACA125) intramuscularly (IM) on weeks 0, 2, 4, 6, 10, and 14 in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive higher-dose MOAB ACA125 IM as in arm I.
- Arm III: Patients receive lower-dose MOAB ACA125 subcutaneously (SC) on weeks 0, 2, 4, 6, 10, and 14 in the absence of disease progression or unacceptable toxicity.
- Arm IV: Patients receive higher-dose MOAB ACA125 SC as in arm III. Patients are followed every 6-12 weeks for 2 years.
PROJECTED ACCRUAL: A total of 40 patients (10 patients per cohort) will be accrued for this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- None
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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed ovarian epithelial, fallopian tube, or peritoneal cancer
- •Stage II-IV
- •Initially treated with surgery and at least 1 platinum-based chemotherapy regimen
- •Must have relapsed after initial treatment and completed chemotherapy for recurrent disease
- •Asymptomatic residual measurable disease on CT scan and/or an elevated CA 125 allowed
- •Complete clinical remission allowed, defined by the following criteria:
- •CA 125 no greater than 35 IU/mL
- •No objective evidence of disease by CT scan
- •Normal physical examination
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Karnofsky 70-100%
- •Life expectancy
- •At least 3 months
- •Hematopoietic
- •WBC at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 10 g/dL
- •Bilirubin no greater than 2 times normal
- •ALT no greater than 2 times normal
- •Alkaline phosphatase no greater than 2 times normal
- •Creatinine no greater than 1.5 times normal
- •Not pregnant or nursing
- •No potential for child bearing
- •Human antimurine antibody negative
- •HIV negative
- •No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
- •No active infection
- •No known autoimmune disease (e.g., rheumatoid arthritis or ulcerative colitis)
- •No known immune deficiency (e.g., hypogammaglobulinemia)
- •No known allergy to murine proteins
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •At least 6 weeks since prior interferon
- •At least 6 weeks since prior immunotherapy or biological response modifiers
- •No prior anticancer vaccine
- •Chemotherapy
- •See Disease Characteristics
- •At least 3 weeks since prior cytotoxic or investigational chemotherapy
- •Endocrine therapy
- •No concurrent steroids
- •Radiotherapy
- •At least 4 weeks since prior radiotherapy
- •See Disease Characteristics
- •At least 1 week since prior antibiotics
- •No concurrent cyclosporine
- •No other concurrent immunosuppressive therapy
排除标准
- 未提供
研究者
研究点 (1)
Loading locations...
相似试验
终止
2 期
Vaccine Therapy, Trastuzumab, and Vinorelbine in Treating Women With Locally Recurrent or Metastatic Breast CancerBreast CancerNCT00088985UNC Lineberger Comprehensive Cancer Center56
终止
1 期
Vaccine Therapy in Patients With Stages IIIB/IV Non-Small Cell Lung Cancer Who Have Finished First-Line ChemotherapyLung CancerNCT00534209University of Miami1
已完成
1 期
Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Recurrent Metastatic MelanomaMelanoma (Skin)NCT00019175National Cancer Institute (NCI)
终止
2 期
Phase II Study of Allo LMI Vaccine With IL-2 for Stable Metastatic Breast CaBreast CancerNCT00784524Masonic Cancer Center, University of Minnesota14
已完成
1 期
Monoclonal Antibody Therapy in Treating Patients With Stage III or Stage IV MelanomaMelanoma (Skin)NCT00004184University of Alabama at Birmingham50