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Sponsors and Collaborators: |
St. Jude Children's Research Hospital Children's Hospital of Philadelphia National Cancer Institute (NCI) |
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Information provided by: | St. Jude Children's Research Hospital |
ClinicalTrials.gov Identifier: | NCT00187057 |
This is a pilot/feasibility study designed to investigate the feasibility of treating children with A-T and cancer with regimens nearly as intense as non-A-T patients with cancer receive.
Condition | Intervention |
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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 |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Pilot Study I for Treatment of Cancer in Children With Ataxia-Telangiectasia |
Estimated Enrollment: | 30 |
Study Start Date: | September 2002 |
Estimated Study Completion Date: | September 2012 |
Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1
Acute Lymphoblastic Leukemia (ALL) Low Risk
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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.
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2
Acute Lymphoblastic Leukemia (ALL) - High Risk
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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.
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3A
B-Cell Non-Hodgkins Lymphoma (Group A)
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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.
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3B
B-Cell Non-Hodgkins Lymphoma (Group B)
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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
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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.
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Ages Eligible for Study: | up to 10 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria
• Patients who do not have a diagnosis of Ataxia Telangiectasia (A-T)
United States, Tennessee | |
St. Jude Children's Research Hospital | |
Memphis, Tennessee, United States, 38105 |
Principal Investigator: | John T. Sandlund, MD | St. Jude Children's Research Hospital |
Responsible Party: | St. Jude Children's Research Hospital ( John T. Sandlund, MD/Principle Investigator ) |
Study ID Numbers: | AT-1 |
Study First Received: | September 12, 2005 |
Last Updated: | June 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00187057 |
Health Authority: | United States: Institutional Review Board |
Ataxia, alphafetoprotein |
Dexamethasone Prednisone Daunorubicin Ataxia-Telangiectasia Vinblastine Cyclophosphamide 6-Mercaptopurine Brain Diseases Etoposide phosphate Signs and Symptoms Telangiectasis Ataxia Methotrexate Ataxia Telangiectasia Etoposide |
Cerebellar ataxia Cytarabine Dexamethasone acetate Neurocutaneous Syndromes Asparaginase Metabolic Diseases Vascular Diseases Vincristine Central Nervous System Diseases Dyskinesias Immunologic Deficiency Syndromes Doxorubicin Folic Acid Cerebellar Ataxia Genetic Diseases, Inborn |
Anti-Inflammatory Agents Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs DNA Repair-Deficiency Disorders Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Reproductive Control Agents Antibiotics, Antineoplastic Hormones Therapeutic Uses Abortifacient Agents |
Cardiovascular Diseases Dermatologic Agents Alkylating Agents Nucleic Acid Synthesis Inhibitors Antineoplastic Agents, Hormonal Immune System Diseases Mitosis Modulators Nervous System Diseases Gastrointestinal Agents Enzyme Inhibitors Antimitotic Agents Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Glucocorticoids Immunosuppressive Agents |