A Randomized Phase III Trial in Patients With Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer With a Polyvalent Vaccine-KLH Conjugate + OPT-821 Versus OPT-821
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Progression-free survival
研究概览
简要总结
RATIONALE: Vaccines made from tumor antigens may help the body build an effective immune response to kill tumor cells. Biological therapies, such as OPT-821, may stimulate the immune system in different ways and stop tumor cells from growing. Giving vaccine therapy together with OPT-821 may kill more tumor cells. It is not yet known whether giving vaccine therapy together with OPT-821 is more effective than OPT-821 alone in treating ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.
PURPOSE: This randomized phase III trial is studying vaccine therapy and OPT-821 to see how well they work compared with OPT-821 alone in treating patients with ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer in complete remission.
详细描述
OBJECTIVES:
Primary
- To compare the progression-free survival of patients with ovarian epithelial, fallopian tube, or primary peritoneal cancer in second or third complete clinical remission treated with a polyvalent antigen-KLH conjugate vaccine (GM2-KLH, Globo-H-KLH, Tn-MUC1-32mer-KLH, TF-KLH, and sTn-KLH) in combination with OPT-821 vs OPT-821 alone.
Secondary
- To compare the incidence of toxicities in patients treated with these regimens.
- To compare the overall survival of patients treated with these regimens.
- To characterize the immune response (by ELISA) in a limited sampling of patients, in order to determine if the outcome correlates with antigen-specific immune titers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 120 Years（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 primary peritoneal cancer
- •Any stage or grade at diagnosis allowed
- •Has undergone initial cytoreductive surgery or received at least one platinum-based chemotherapy regimen
- •Recurred on initial therapy, but is now in second or third complete clinical remission as defined by the following:
- •Serum CA-125 normal
- •Negative physical examination
- •No definitive evidence of disease by CT scan of the abdomen and pelvis (lymph nodes and/or soft tissue abnormalities ≤ 1.0 cm are not considered definitive evidence of disease)
- •A positive PET scan is allowed provided other criteria are met and MRI or CT scan are negative
- •Completed last course of chemotherapy within the past 4 months
- •PATIENT CHARACTERISTICS:
- •GOG performance status 0-2
- •Absolute neutrophil count ≥ 1,000/mm³
- •Platelet count ≥ 100,000/mm³
- •Serum creatinine ≤ 1.5 times upper limit of normal (ULN)
- •Bilirubin ≤ 2.0 times ULN
- •SGOT ≤ 2.0 times ULN
- •Alkaline phosphatase ≤ 2.0 times ULN
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients receive polyvalent antigen-KLH conjugate vaccine in combination with OPT-821 subcutaneously (SC) once in weeks 1, 2, 3, 7, 15, 27, 39, 51, 63, 75, and 87.
干预措施: immunological adjuvant OPT-821 (Biological)
Arm II
Patients receive OPT-821 SC once in weeks 1, 2, 3, 7, 15, 27, 39, 51, 63, 75, and 87.
干预措施: immunological adjuvant OPT-821 (Biological)
Arm I
Patients receive polyvalent antigen-KLH conjugate vaccine in combination with OPT-821 subcutaneously (SC) once in weeks 1, 2, 3, 7, 15, 27, 39, 51, 63, 75, and 87.
干预措施: polyvalent antigen-KLH conjugate vaccine (Biological)
结局指标
主要结局
Progression-free survival
次要结局
- Correlation of outcome with antigen-specific immune titers in a limited sampling of patients
- Incidence of toxicities
- Overall survival