We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study for Treatment of Cancer in Children With Ataxia-telangiectasia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00187057
First Posted: September 16, 2005
Last Update Posted: August 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Children's Hospital of Philadelphia
National Cancer Institute (NCI)
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
  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
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

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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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).
  Contacts and Locations
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
  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
First Submitted: September 12, 2005
First Posted: September 16, 2005
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