ABT-751 With Chemotherapy for Relapsed Pediatric ALL
Information source: Therapeutic Advances in Childhood Leukemia Consortium
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Recurrent Pediatric ALL; Relapsed Pediatric ALL; Acute Lymphoblastic Leukemia; Refractory Pediatric ALL
Intervention: ABT-751 (Drug); dexamethasone (Drug); PEG-asparaginase (Drug); doxorubicin (Drug); cytarabine (Drug); methotrexate (Drug); cyclophosphamide (Drug); 6-thioguanine (Drug)
Phase: Phase 1
Status: Terminated
Sponsored by: Therapeutic Advances in Childhood Leukemia Consortium Official(s) and/or principal investigator(s): Paul S Gaynon, MD, Study Chair, Affiliation: Childrens Hospital Los Angeles, Therapeutic Advances in Childhood Leukemia Consortium
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.
Clinical Details
Official title: A Phase I/II Trial of ABT-751 Combined With Dexamethasone, PEG-asparaginase, and Doxorubicin in Relapsed Acute Lymphoblastic Leukemia (ALL)
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Dose Limiting ToxicityMaximum Tolerated Dose
Secondary outcome: Rate of RemissionPharmacokinetic profile on blood and CSF
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.
Eligibility
Minimum age: N/A.
Maximum age: 21 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
City of Hope, Duarte, California 91010, United States
Childrens Hospital Los Angeles, Los Angeles, California 90027, United States
Stanford University Medical Center, Palo Alto, California 94304-1812, United States
UCSF School of Medicine, San Francisco, California 94143-0106, United States
University of Miami Cancer Center, Miami, Florida 33136, United States
C.S. Mott Children's Hospital, Ann Arbor, Michigan 48109-0914, United States
Childrens Hospital & Clinics of Minnesota, Minneapolis, Minnesota 55404-4597, United States
New York University Medical Center, New York, New York 10016, United States
Seattle Children's Hospital, Seattle, Washington 98105, United States
Additional Information
Click here for more information about this protocol and the Therapeutic Advances in Childhood Leukemia Consortium
Starting date: May 2006
Last updated: November 28, 2012
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