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ABT-751 With Chemotherapy for Relapsed Pediatric ALL

This study has been terminated.
(The study was stopped due to poor accrual and lack of funding.)
Sponsor:
Information provided by (Responsible Party):
Therapeutic Advances in Childhood Leukemia Consortium
ClinicalTrials.gov Identifier:
NCT00439296
First received: February 21, 2007
Last updated: November 28, 2012
Last verified: November 2012

February 21, 2007
November 28, 2012
May 2006
June 2009   (final data collection date for primary outcome measure)
  • Dose Limiting Toxicity [ Time Frame: Each dose level is evaluated ] [ Designated as safety issue: Yes ]
  • Maximum Tolerated Dose [ Time Frame: Each dose level is evaluated ] [ Designated as safety issue: Yes ]
  • Dose Limiting Toxicity
  • Maximum Tolerated Dose
Complete list of historical versions of study NCT00439296 on ClinicalTrials.gov Archive Site
  • Rate of Remission [ Time Frame: Patients on each dose level will be evaluated for rate of remission. ] [ Designated as safety issue: No ]
  • Pharmacokinetic profile on blood and CSF [ Time Frame: Results will be evaluated upon completion of enrollment to the study. ] [ Designated as safety issue: No ]
  • Rate of Remission
  • Pharmacokinetic profile on blood and CSF
Not Provided
Not Provided
 
ABT-751 With Chemotherapy for Relapsed Pediatric ALL
A Phase I/II Trial of ABT-751 Combined With Dexamethasone, PEG-asparaginase, and Doxorubicin in Relapsed Acute Lymphoblastic Leukemia (ALL)

This is a phase I/II study of an investigational drug called ABT-751, produced by Abbott Laboratories, given in combination with chemotherapy drugs used to treat acute lymphoblastic leukemia (ALL) that has come back (recurred). The phase I portion of this study is being done to find the highest dose of ABT-751 that can be given safely in combination with other chemotherapy drugs. A safe dose is one that does not result in unacceptable side effects. After a safe dose for ABT-751 given with chemotherapy has been found, the study will add additional patients to find out if ABT-751 (given at the maximal safe dose) when given with additional chemotherapy is an effective therapy for the treatment of children with relapsed ALL. It is expected that approximately 15-35 children and young adults will take part in this study.

All patients will receive the 2 courses of chemotherapy unless medical complications prevent the administration of some of the drugs. Treatment for the first 2 courses of therapy will last about 2 months.

Treatment on this study will consist of a combination of 8 anti-cancer medications. The 8 anticancer medicines are ABT-751, dexamethasone, PEG-asparaginase, doxorubicin, cytarabine (Ara-C), methotrexate (MTX), cyclophosphamide, and 6-thioguanine. All the drugs except ABT-751 are well known anti-cancer drugs and have been used extensively in the treatment of cancer.

During the Phase I portion of this study, when you enroll, you will be given an assigned dose of ABT-751. The dose of ABT-751 will be based on doses given in previous studies done with adults and children. At each dose level of ABT-751, between 3 and 6 children will receive ABT-751 in combination with chemotherapy. If the side effects are not too severe, the next group of children will receive a higher dose. The dose will continue to be increased until we find the dose that causes serious side effects. Your dose of ABT-751 will not be increased. If you have bad side effects, your dose may be decreased.

The dose used during the Phase 2 part of this study will be determined by the outcome of the Phase I study. The highest dose used in Phase I that was tolerated without serious side effects will be the one used in Phase 2.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Recurrent Pediatric ALL
  • Relapsed Pediatric ALL
  • Acute Lymphoblastic Leukemia
  • Refractory Pediatric ALL
  • Drug: ABT-751
    Oral capsule to be given daily for 21 days.
  • Drug: dexamethasone
    IV or Oral daily for 14 days
  • Drug: PEG-asparaginase
    Intramuscular injection
  • Drug: doxorubicin
    IV infusion
  • Drug: cytarabine
    Intrathecal dose on day 1
  • Drug: methotrexate
    Intrathecal dose
  • Drug: cyclophosphamide
    Intravenous dose
  • Drug: 6-thioguanine
    Oral dose, course #2
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
9
September 2009
June 2009   (final data collection date for primary outcome measure)

This is an abbreviated list...

Inclusion Criteria:

  • Patients must be less than 21 years of age to be participate in this study.
  • Patients must have relapsed acute lymphoblastic leukemia (ALL) without evidence of central nervous system (CNS) disease.
  • Patients must have adequate kidney, heart and liver function.
  • Must be able to swallow capsules.

Exclusion Criteria:

  • Patients who are pregnant or breast feeding.
  • Patients who have an allergy to Asparaginase products or sulfa-containing medications.
  • Patients who have an active uncontrolled infection.
  • Patients who have numbness or tingling in the hands or feet or constipation.
Both
up to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00439296
T2005-001
Yes
Therapeutic Advances in Childhood Leukemia Consortium
Therapeutic Advances in Childhood Leukemia Consortium
Not Provided
Study Chair: Paul S Gaynon, MD Childrens Hospital Los Angeles, Therapeutic Advances in Childhood Leukemia Consortium
Therapeutic Advances in Childhood Leukemia Consortium
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP