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Study for Treatment of Cancer in Children With Ataxia-telangiectasia

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ClinicalTrials.gov Identifier: NCT00187057
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : August 27, 2015
Sponsor:
Collaborators:
Children's Hospital of Philadelphia
National Cancer Institute (NCI)
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

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.

Condition or disease Intervention/treatment Phase
Ataxia-Telangiectasia Drug: vinblastine, vincristine, prednisone, daunorubicin Drug: doxorubicin, methotrexate, cyclophosphamide, L-asparaginase Drug: etoposide, cytarabine, mercaptopurine Drug: dexamethasone, procarbazine Procedure: chemotherapy, intrathecal chemotherapy, steroid therapy Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study I for Treatment of Cancer in Children With Ataxia-Telangiectasia
Study Start Date : September 2002
Actual Primary Completion Date : August 2006
Actual Study Completion Date : June 2013


Arm Intervention/treatment
1
Acute Lymphoblastic Leukemia (ALL) Low Risk
Drug: vinblastine, vincristine, prednisone, daunorubicin
See Detailed Description section for details of treatment interventions.

Drug: doxorubicin, methotrexate, cyclophosphamide, L-asparaginase
See Detailed Description section for details of treatment interventions.

Drug: etoposide, cytarabine, mercaptopurine
See Detailed Description section for details of treatment interventions.

Drug: dexamethasone, procarbazine
See Detailed Description section for details of treatment interventions.

Procedure: chemotherapy, intrathecal chemotherapy, steroid therapy
See Detailed Description section for details of treatment interventions.

2
Acute Lymphoblastic Leukemia (ALL) - High Risk
Drug: vinblastine, vincristine, prednisone, daunorubicin
See Detailed Description section for details of treatment interventions.

Drug: doxorubicin, methotrexate, cyclophosphamide, L-asparaginase
See Detailed Description section for details of treatment interventions.

Drug: etoposide, cytarabine, mercaptopurine
See Detailed Description section for details of treatment interventions.

Drug: dexamethasone, procarbazine
See Detailed Description section for details of treatment interventions.

Procedure: chemotherapy, intrathecal chemotherapy, steroid therapy
See Detailed Description section for details of treatment interventions.

3A
B-Cell Non-Hodgkins Lymphoma (Group A)
Drug: vinblastine, vincristine, prednisone, daunorubicin
See Detailed Description section for details of treatment interventions.

Drug: doxorubicin, methotrexate, cyclophosphamide, L-asparaginase
See Detailed Description section for details of treatment interventions.

Drug: etoposide, cytarabine, mercaptopurine
See Detailed Description section for details of treatment interventions.

Drug: dexamethasone, procarbazine
See Detailed Description section for details of treatment interventions.

Procedure: chemotherapy, intrathecal chemotherapy, steroid therapy
See Detailed Description section for details of treatment interventions.

3B
B-Cell Non-Hodgkins Lymphoma (Group B)
Drug: vinblastine, vincristine, prednisone, daunorubicin
See Detailed Description section for details of treatment interventions.

Drug: doxorubicin, methotrexate, cyclophosphamide, L-asparaginase
See Detailed Description section for details of treatment interventions.

Drug: etoposide, cytarabine, mercaptopurine
See Detailed Description section for details of treatment interventions.

Drug: dexamethasone, procarbazine
See Detailed Description section for details of treatment interventions.

Procedure: chemotherapy, intrathecal chemotherapy, steroid therapy
See Detailed Description section for details of treatment interventions.

4
Hodgkins Disease
Drug: vinblastine, vincristine, prednisone, daunorubicin
See Detailed Description section for details of treatment interventions.

Drug: doxorubicin, methotrexate, cyclophosphamide, L-asparaginase
See Detailed Description section for details of treatment interventions.

Drug: etoposide, cytarabine, mercaptopurine
See Detailed Description section for details of treatment interventions.

Drug: dexamethasone, procarbazine
See Detailed Description section for details of treatment interventions.

Procedure: chemotherapy, intrathecal chemotherapy, steroid therapy
See Detailed Description section for details of treatment interventions.




Primary Outcome Measures :
  1. To determine the feasibility of delivering modified intensive chemotherapy to children with A-T who present with cancer. [ Time Frame: The completion of treatment ]


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Ages Eligible for Study:   up to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients who do not have a diagnosis of Ataxia Telangiectasia (A-T).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00187057


Locations
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
St. Jude Children's Research Hospital
Children's Hospital of Philadelphia
National Cancer Institute (NCI)
Investigators
Principal Investigator: John T. Sandlund, MD St. Jude Children's Research Hospital

Additional Information:
Publications:
Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00187057     History of Changes
Other Study ID Numbers: AT-1
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: August 27, 2015
Last Verified: August 2013

Keywords provided by St. Jude Children's Research Hospital:
Ataxia
alphafetoprotein

Additional relevant MeSH terms:
Ataxia Telangiectasia
Ataxia
Cerebellar Ataxia
Telangiectasis
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cerebellar Diseases
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Spinocerebellar Ataxias
Neurocutaneous Syndromes
Genetic Diseases, Inborn
DNA Repair-Deficiency Disorders
Metabolic Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Dexamethasone
Prednisone
Cyclophosphamide
Doxorubicin
Methotrexate
Etoposide
Cytarabine
Vincristine
Daunorubicin
Asparaginase