Phase II Prospective Trial of Vaccine Responses in Childhood Cancer Survivors
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- To prospectively determine the response rate and duration of protective titers following revaccination with routine childhood immunizations in pediatric survivors of childhood cancer.
研究概览
简要总结
This study will look at your body's response to the new immunizations. We want to see how well they will protect you. Immunization is the same as vaccination. Our goal is to protect you as much as we can. We do not want you to have the measles, mumps, or whooping cough. We are doing the study because there is no standard way to re-immunize people after cancer treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must be < or less 18 years of age at cancer diagnosis
- •Patient must be 3 to 24months following completion of chemotherapy for malignant disease.
- •For patients <12 months following completion of therapy, CR must be documented within 3 months of enrollment.
- •For patients >12 months, CR must be documented at approximately 12 months and then only as clinically indicated
- •i. For patients with leukemia: bone marrow aspirate defined as <5% blasts, absence of cytogenetic abnormality by FISH or karyotype (if applicable) and no evidence of CSF involvement (if applicable) ii. For patients with solid tumors remission will be determined by appropriate radiologic scans, and other tests, including bone marrow aspirate and biopsies demonstrating absence of extrinsic cells and absence of specific FISH or cytogenetic abnormality (if applicable), iii. For patients with lymphoma, remission will be determined by bone marrow aspirate and biopsy, radiologic scans and other tests. Bone marrow will show <5% blasts, absence of cytogenetic abnormality by FISH or karyotype (if applicable), and flow cytometry (if lymphoma specific marker present) and absence of CNS disease by spinal fluid (if applicable)
- •Patient may be of either gender and of any ethnic background
- •Patients or their guardians must be able to understand the nature and risk of the proposed study and be able to sign consent.
排除标准
- •Karnofsky score <70%.
- •Female patients who are pregnant or lactating.
- •Patients who have received an autologous or allogeneic HCT.
- •Active uncontrolled bacterial or fungal infection.
- •Patients who have a history of previous allergic reaction to vaccinations currently recommended by the ACIP.
- •Patients on any immunosuppressive drugs.
- •HIV-1,2 sero-positive patients.
- •Patients or guardians not signing informed consent.
- •Patients with prior allergic reaction to any vaccine component or to latex.
- •Patients who have received Rituximab.
研究组 & 干预措施
A
Immunization Schedule patients <7 years.
干预措施: Immunization Schedule patients <7 years. (Biological)
B
Immunization Schedule patients > or = to 7 years and <11 years of age
干预措施: Immunization Schedule patients > or = to 7 years and <11 years of age (Biological)
C
Immunization Schedule patients > or = to 11 years of age
干预措施: Immunization Schedule patients > or = to 11 years of age (Biological)
结局指标
主要结局
To prospectively determine the response rate and duration of protective titers following revaccination with routine childhood immunizations in pediatric survivors of childhood cancer.
时间窗: conclusion of study
Percentage of Participants With Protective Antibody Titers After Vaccination
时间窗: Up to 2 years
To prospectively determine the response rate and duration of protective titers following revaccination with routine childhood immunizations in pediatric survivors of childhood cancer.
次要结局
- To determine whether in vitro parameters of lymphoid reconstitution correlate with response and duration of response.(conclusion of study)
- Median Absolute Lymphocyte Count (ALC), the Absolute CD4+ T Cell Count, and the Absolute CD8+ T Cell Count at Baseline(Baseline)