Clinical Trial: Study for Treatment of Cancer in Children With Ataxia-telangiectasia
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Pilot Study I for Treatment of Cancer in Children With Ataxia-Telangiectasia
Brief Summary: 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.
Detailed Summary:
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:
- Acute Lymphoblastic Leukemia (ALL) Low Risk:
Induction:
Prednisone 40 mg/m2/day PO days 1-28
Sponsor: St. Jude Children's Research Hospital
Current Primary Outcome: To determine the feasibility of delivering modified intensive chemotherapy to children with A-T who present with cancer. [ Time Frame: The completion of treatment ]
Original Primary Outcome: To learn if modified standard chemotherapy can be given to children with A-T. To study the effects (good and bad) of the research treatment. To study cancer cells from children with A-T in the laboratory.
Current Secondary Outcome:
Original Secondary Outcome:
Information By: St. Jude Children's Research Hospital
Dates:
Date Received: September 12, 2005
Date Started: September 2002
Date Completion:
Last Updated: August 26, 2015
Last Verified: August 2013
