Pilot Study I for Treatment of Cancer in Children With Ataxia-Telangiectasia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- To determine the feasibility of delivering modified intensive chemotherapy to children with A-T who present with cancer.
研究概览
简要总结
This is a pilot/feasibility study designed to investigate the feasibility of treating children with Ataxia-Telangiectasia (A-T) and cancer with regimens nearly as intense as non-A-T patients with cancer would receive.
详细描述
Approximately 10-30% of A-T patients will develop a malignancy during their lifetime. The vast majority of these cancers are of lymphoid origin. There is no consensus regarding the optimal strategy for treating children with A-T who develop hematopoietic malignancies. Historically, many of these children have been treated with therapy that is much less intensive than the conventional approach for non-A-T patients with similar malignancies during the corresponding treatment era. Although these less intensive approaches may have stemmed from perceptions that these children would not tolerate intensive therapy, there is in fact no data to suggest that these children cannot tolerate intensive therapy. However, it is clear that children with A-T require a modification in certain components of intensive therapy.
To provide children with A-T and either ALL or malignant lymphoma the best chance for a cure, we propose to use modern therapeutic strategies with minimal modifications which address the unique toxicity profile encountered in treating children with A-T.
Secondary objectives include:
- To clinically and biologically characterize the malignancies occurring in children with A-T (usually malignant lymphoma or ALL). This will include in vitro drug sensitivity screening.
- To study chemotherapy-induced DNA damage in children with A-T.
Detailed Description of Treatment Plan:
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
- — 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must have a diagnosis of Ataxia-Telangiectasia (A-T).
- •Patient must have a diagnosis of either acute lymphoblastic leukemia (ALL) or lymphoma (non-Hodgkin lymphoma or Hodgkin's disease).
- •Patients with other malignancies (solid tumors, rare malignancies, or relapsed hematopoietic malignancies) will be eligible for the biologic studies of this protocol; they will receive best clinical management chemotherapy.
- •Patients do not have to be previously untreated. If prior chemotherapy has already started (up through induction), therapy will be continued according to protocol at a clinically appropriate time point.
排除标准
- •Patients who do not have a diagnosis of Ataxia Telangiectasia (A-T).
研究组 & 干预措施
1
Acute Lymphoblastic Leukemia (ALL) Low Risk
干预措施: vinblastine, vincristine, prednisone, daunorubicin (Drug)
1
Acute Lymphoblastic Leukemia (ALL) Low Risk
干预措施: doxorubicin, methotrexate, cyclophosphamide, L-asparaginase (Drug)
1
Acute Lymphoblastic Leukemia (ALL) Low Risk
干预措施: etoposide, cytarabine, mercaptopurine (Drug)
1
Acute Lymphoblastic Leukemia (ALL) Low Risk
干预措施: dexamethasone, procarbazine (Drug)
1
Acute Lymphoblastic Leukemia (ALL) Low Risk
干预措施: chemotherapy, intrathecal chemotherapy, steroid therapy (Procedure)
3A
B-Cell Non-Hodgkins Lymphoma (Group A)
干预措施: vinblastine, vincristine, prednisone, daunorubicin (Drug)
2
Acute Lymphoblastic Leukemia (ALL) - High Risk
干预措施: vinblastine, vincristine, prednisone, daunorubicin (Drug)
2
Acute Lymphoblastic Leukemia (ALL) - High Risk
干预措施: doxorubicin, methotrexate, cyclophosphamide, L-asparaginase (Drug)
2
Acute Lymphoblastic Leukemia (ALL) - High Risk
干预措施: etoposide, cytarabine, mercaptopurine (Drug)
2
Acute Lymphoblastic Leukemia (ALL) - High Risk
干预措施: dexamethasone, procarbazine (Drug)
2
Acute Lymphoblastic Leukemia (ALL) - High Risk
干预措施: chemotherapy, intrathecal chemotherapy, steroid therapy (Procedure)
3A
B-Cell Non-Hodgkins Lymphoma (Group A)
干预措施: doxorubicin, methotrexate, cyclophosphamide, L-asparaginase (Drug)
3A
B-Cell Non-Hodgkins Lymphoma (Group A)
干预措施: etoposide, cytarabine, mercaptopurine (Drug)
3A
B-Cell Non-Hodgkins Lymphoma (Group A)
干预措施: dexamethasone, procarbazine (Drug)
3B
B-Cell Non-Hodgkins Lymphoma (Group B)
干预措施: dexamethasone, procarbazine (Drug)
3A
B-Cell Non-Hodgkins Lymphoma (Group A)
干预措施: chemotherapy, intrathecal chemotherapy, steroid therapy (Procedure)
3B
B-Cell Non-Hodgkins Lymphoma (Group B)
干预措施: vinblastine, vincristine, prednisone, daunorubicin (Drug)
3B
B-Cell Non-Hodgkins Lymphoma (Group B)
干预措施: doxorubicin, methotrexate, cyclophosphamide, L-asparaginase (Drug)
3B
B-Cell Non-Hodgkins Lymphoma (Group B)
干预措施: etoposide, cytarabine, mercaptopurine (Drug)
3B
B-Cell Non-Hodgkins Lymphoma (Group B)
干预措施: chemotherapy, intrathecal chemotherapy, steroid therapy (Procedure)
4
Hodgkins Disease
干预措施: vinblastine, vincristine, prednisone, daunorubicin (Drug)
4
Hodgkins Disease
干预措施: doxorubicin, methotrexate, cyclophosphamide, L-asparaginase (Drug)
4
Hodgkins Disease
干预措施: etoposide, cytarabine, mercaptopurine (Drug)
4
Hodgkins Disease
干预措施: dexamethasone, procarbazine (Drug)
4
Hodgkins Disease
干预措施: chemotherapy, intrathecal chemotherapy, steroid therapy (Procedure)
结局指标
主要结局
To determine the feasibility of delivering modified intensive chemotherapy to children with A-T who present with cancer.
时间窗: The completion of treatment
次要结局
未报告次要终点