Study for Treatment of Cancer in Children With Ataxia-telangiectasia

This study has been completed.
Sponsor:
Collaborators:
Children's Hospital of Philadelphia
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00187057
First received: September 12, 2005
Last updated: August 26, 2013
Last verified: August 2013
  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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study I for Treatment of Cancer in Children With Ataxia-Telangiectasia

Resource links provided by NLM:


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 ]

Enrollment: 6
Study Start Date: September 2002
Study Completion Date: June 2013
Primary Completion Date: August 2006 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: John T. Sandlund, MD St. Jude Children's Research Hospital
  More Information

Additional Information:
Publications:
Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00187057     History of Changes
Other Study ID Numbers: AT-1
Study First Received: September 12, 2005
Last Updated: August 26, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 31, 2014