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Trial record 10 of 11 for:    "Childhood Leukemia" | "Dexamethasone acetate"

ABT-751 With Chemotherapy for Relapsed Pediatric ALL

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.
ClinicalTrials.gov Identifier: NCT00439296
Recruitment Status : Terminated (The study was stopped due to poor accrual and lack of funding.)
First Posted : February 23, 2007
Last Update Posted : November 30, 2012
Sponsor:
Information provided by (Responsible Party):
Therapeutic Advances in Childhood Leukemia Consortium

Tracking Information
First Submitted Date  ICMJE February 21, 2007
First Posted Date  ICMJE February 23, 2007
Last Update Posted Date November 30, 2012
Study Start Date  ICMJE May 2006
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2009)
  • Dose Limiting Toxicity [ Time Frame: Each dose level is evaluated ]
  • Maximum Tolerated Dose [ Time Frame: Each dose level is evaluated ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 21, 2007)
  • Dose Limiting Toxicity
  • Maximum Tolerated Dose
Change History Complete list of historical versions of study NCT00439296 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2009)
  • Rate of Remission [ Time Frame: Patients on each dose level will be evaluated for rate of remission. ]
  • Pharmacokinetic profile on blood and CSF [ Time Frame: Results will be evaluated upon completion of enrollment to the study. ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2007)
  • Rate of Remission
  • Pharmacokinetic profile on blood and CSF
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ABT-751 With Chemotherapy for Relapsed Pediatric ALL
Official Title  ICMJE A Phase I/II Trial of ABT-751 Combined With Dexamethasone, PEG-asparaginase, and Doxorubicin in Relapsed Acute Lymphoblastic Leukemia (ALL)
Brief Summary 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Recurrent Pediatric ALL
  • Relapsed Pediatric ALL
  • Acute Lymphoblastic Leukemia
  • Refractory Pediatric ALL
Intervention  ICMJE
  • 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
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 29, 2012)
9
Original Enrollment  ICMJE
 (submitted: February 21, 2007)
35
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00439296
Other Study ID Numbers  ICMJE T2005-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Therapeutic Advances in Childhood Leukemia Consortium
Study Sponsor  ICMJE Therapeutic Advances in Childhood Leukemia Consortium
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Paul S Gaynon, MD Childrens Hospital Los Angeles, Therapeutic Advances in Childhood Leukemia Consortium
PRS Account Therapeutic Advances in Childhood Leukemia Consortium
Verification Date November 2012

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