Study for Treatment of Cancer in Children With Ataxia-Telangiectasia - Full Text View

Sponsors and Collaborators:	St. Jude Children's Research Hospital Children's Hospital of Philadelphia National Cancer Institute (NCI)
Information provided by:	St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:	NCT00187057

Purpose

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	Intervention
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

Genetics Home Reference related topics: ataxia-telangiectasia Friedreich ataxia

MedlinePlus related topics: Ataxia Telangiectasia Cancer

Drug Information available for: Dexamethasone Cyclophosphamide 6-Mercaptopurine Prednisone Vincristine Methotrexate Daunorubicin Doxorubicin Daunorubicin hydrochloride Doxorubicin hydrochloride Etoposide Dexamethasone acetate Doxiproct plus Myocet Vinblastine sulfate Cytarabine Procarbazine hydrochloride Procarbazine Vinblastine Dexamethasone Sodium Phosphate Mercaptopurine L-Asparaginase

U.S. FDA Resources

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

Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:

To determine the feasibility of delivering modified intensive chemotherapy to children with A-T who present with cancer. [ Time Frame: The completion of treatment ] [ Designated as safety issue: Yes ]

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
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.

Show Detailed Description

Eligibility

Ages Eligible for Study:	up to 10 Years
Genders Eligible for Study:	Both
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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

Additional Information:

St. Jude Children's Research Hospital This link exits the ClinicalTrials.gov site

Publications:

Sandlund JT, Kastan MB, Kennedy W, Behm F, Entrekin E, Pui CH, Kalwinsky DT, Raimondi SC. A subtle t(3;8) results in plausible juxtaposition of MYC and BCL6 in a child with Burkitt lymphoma/leukemia and ataxia-telangiectasia. Cancer Genet Cytogenet. 2006 Jul 1;168(1):69-72.

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:	February 27, 2009
ClinicalTrials.gov Identifier:	NCT00187057 History of Changes
Health Authority:	United States: Institutional Review Board

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

Ataxia
alphafetoprotein

Study placed in the following topic categories:

Dexamethasone
Anti-Inflammatory Agents
Prednisone
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Vinblastine
6-Mercaptopurine
Brain Diseases
Hormones
Methotrexate
Ataxia Telangiectasia
Metabolic Disorder
Etoposide
Asparaginase

Metabolic Diseases
Antineoplastic Agents, Hormonal
Vincristine
Dyskinesias
Glucocorticoids
Doxorubicin
Folic Acid
Cerebellar Ataxia
Procarbazine
Antineoplastic Agents, Phytogenic
Spinocerebellar Ataxias
Antimetabolites
Daunorubicin
Ataxia-Telangiectasia
Immunologic Factors

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Dexamethasone
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
DNA Repair-Deficiency Disorders
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Vinblastine
6-Mercaptopurine
Brain Diseases
Hormones
Therapeutic Uses
Abortifacient Agents
Methotrexate

Cardiovascular Diseases
Ataxia Telangiectasia
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Asparaginase
Metabolic Diseases
Antineoplastic Agents, Hormonal
Immune System Diseases
Nervous System Diseases
Abortifacient Agents, Nonsteroidal
Glucocorticoids
Dyskinesias
Doxorubicin
Cerebellar Ataxia
Procarbazine

ClinicalTrials.gov processed this record on May 07, 2009