Study for Treatment of Cancer in Children With Ataxia-telangiectasia

NCT00187057 | Completed

• 1 other identifier: AT-1
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Ataxia-Telangiectasia

Keywords

Ataxia; alphafetoprotein

Outcome Measures

Primary Outcomes (1)

• To determine the feasibility of delivering modified intensive chemotherapy to children with A-T who present with cancer.

  The completion of treatment

Study Arms (5)

1

OTHER

Acute Lymphoblastic Leukemia (ALL) Low Risk

Drug: vinblastine, vincristine, prednisone, daunorubicin; Drug: doxorubicin, methotrexate, cyclophosphamide, L-asparaginase; Drug: etoposide, cytarabine, mercaptopurine; Drug: dexamethasone, procarbazine; Procedure: chemotherapy, intrathecal chemotherapy, steroid therapy

2

OTHER

Acute Lymphoblastic Leukemia (ALL) - High Risk

Drug: vinblastine, vincristine, prednisone, daunorubicin; Drug: doxorubicin, methotrexate, cyclophosphamide, L-asparaginase; Drug: etoposide, cytarabine, mercaptopurine; Drug: dexamethasone, procarbazine; Procedure: chemotherapy, intrathecal chemotherapy, steroid therapy

3A

OTHER

B-Cell Non-Hodgkins Lymphoma (Group A)

Drug: vinblastine, vincristine, prednisone, daunorubicin; Drug: doxorubicin, methotrexate, cyclophosphamide, L-asparaginase; Drug: etoposide, cytarabine, mercaptopurine; Drug: dexamethasone, procarbazine; Procedure: chemotherapy, intrathecal chemotherapy, steroid therapy

3B

OTHER

B-Cell Non-Hodgkins Lymphoma (Group B)

Drug: vinblastine, vincristine, prednisone, daunorubicin; Drug: doxorubicin, methotrexate, cyclophosphamide, L-asparaginase; Drug: etoposide, cytarabine, mercaptopurine; Drug: dexamethasone, procarbazine; Procedure: chemotherapy, intrathecal chemotherapy, steroid therapy

4

OTHER

Hodgkins Disease

Drug: vinblastine, vincristine, prednisone, daunorubicin; Drug: doxorubicin, methotrexate, cyclophosphamide, L-asparaginase; Drug: etoposide, cytarabine, mercaptopurine; Drug: dexamethasone, procarbazine; Procedure: chemotherapy, intrathecal chemotherapy, steroid therapy

Interventions

vinblastine, vincristine, prednisone, daunorubicin DRUG

See Detailed Description section for details of treatment interventions.

1; 2; 3A; 3B; 4

doxorubicin, methotrexate, cyclophosphamide, L-asparaginase DRUG

See Detailed Description section for details of treatment interventions.

1; 2; 3A; 3B; 4

etoposide, cytarabine, mercaptopurine DRUG

See Detailed Description section for details of treatment interventions.

1; 2; 3A; 3B; 4

dexamethasone, procarbazine DRUG

See Detailed Description section for details of treatment interventions.

1; 2; 3A; 3B; 4

chemotherapy, intrathecal chemotherapy, steroid therapy PROCEDURE

See Detailed Description section for details of treatment interventions.

1; 2; 3A; 3B; 4

Eligibility Criteria

• Age: Up to 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead
• Children's Hospital of Philadelphia: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Publications (1)

• 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. doi: 10.1016/j.cancergencyto.2005.12.013.

  PMID: 16772123 BACKGROUND

Related Links

• St. Jude Children's Research Hospital

MeSH Terms

Conditions

Ataxia Telangiectasia; Ataxia

Interventions

Vinblastine; Vincristine; Prednisone; Daunorubicin; Doxorubicin; Methotrexate; Cyclophosphamide; Asparaginase; Etoposide; Cytarabine; Mercaptopurine; Dexamethasone; Procarbazine; Drug Therapy

Condition Hierarchy (Ancestors)

Spinocerebellar Ataxias; Cerebellar Ataxia; Cerebellar Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocutaneous Syndromes; Dyskinesias; Neurologic Manifestations; Telangiectasis; Vascular Diseases; Cardiovascular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Primary Immunodeficiency Diseases; DNA Repair-Deficiency Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Aminoglycosides; Glycosides; Carbohydrates; Aminopterin; Pterins; Pteridines; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Amidohydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Sulfhydryl Compounds; Sulfur Compounds; Purines; Pregnadienetriols; Steroids, Fluorinated; Benzamides; Amides; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Therapeutics

Study Officials

• John T. Sandlund, MD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 16, 2005
• Study Start: September 1, 2002
• Primary Completion: August 1, 2006
• Study Completion: June 1, 2013
• Last Updated: August 27, 2015

Record last verified: 2013-08

Locations

US (1)