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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. 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
Information provided by (Responsible Party):
Therapeutic Advances in Childhood Leukemia Consortium

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.

Condition or disease Intervention/treatment Phase
Recurrent Pediatric ALL Relapsed Pediatric ALL Acute Lymphoblastic Leukemia Refractory Pediatric ALL Drug: ABT-751 Drug: dexamethasone Drug: PEG-asparaginase Drug: doxorubicin Drug: cytarabine Drug: methotrexate Drug: cyclophosphamide Drug: 6-thioguanine Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Trial of ABT-751 Combined With Dexamethasone, PEG-asparaginase, and Doxorubicin in Relapsed Acute Lymphoblastic Leukemia (ALL)
Study Start Date : May 2006
Actual Primary Completion Date : June 2009
Actual Study Completion Date : September 2009

Intervention Details:
  • 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

Primary Outcome Measures :
  1. Dose Limiting Toxicity [ Time Frame: Each dose level is evaluated ]
  2. Maximum Tolerated Dose [ Time Frame: Each dose level is evaluated ]

Secondary Outcome Measures :
  1. Rate of Remission [ Time Frame: Patients on each dose level will be evaluated for rate of remission. ]
  2. Pharmacokinetic profile on blood and CSF [ Time Frame: Results will be evaluated upon completion of enrollment to the study. ]

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.

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT00439296

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United States, California
City of Hope
Duarte, California, United States, 91010
Childrens Hospital Los Angeles
Los Angeles, California, United States, 90027
Stanford University Medical Center
Palo Alto, California, United States, 94304-1812
UCSF School of Medicine
San Francisco, California, United States, 94143-0106
United States, Florida
University of Miami Cancer Center
Miami, Florida, United States, 33136
United States, Michigan
C.S. Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109-0914
United States, Minnesota
Childrens Hospital & Clinics of Minnesota
Minneapolis, Minnesota, United States, 55404-4597
United States, New York
New York University Medical Center
New York, New York, United States, 10016
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Therapeutic Advances in Childhood Leukemia Consortium
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Study Chair: Paul S Gaynon, MD Childrens Hospital Los Angeles, Therapeutic Advances in Childhood Leukemia Consortium

Additional Information:
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Responsible Party: Therapeutic Advances in Childhood Leukemia Consortium Identifier: NCT00439296     History of Changes
Other Study ID Numbers: T2005-001
First Posted: February 23, 2007    Key Record Dates
Last Update Posted: November 30, 2012
Last Verified: November 2012
Keywords provided by Therapeutic Advances in Childhood Leukemia Consortium:
Acute Lymphoblastic Leukemia
Therapeutic Advances in Childhood Leukemia
Relapsed ALL
Refractory ALL
Relapsed pediatric ALL
Refractory pediatric ALL
Additional relevant MeSH terms:
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Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Liposomal doxorubicin
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal