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A Phase I/II Trial of ABT-751 Combined With Dexamethasone, PEG-asparaginase, and Doxorubicin in Relapsed Acute Lymphoblastic Leukemia (ALL)


Phase 1
N/A
21 Years
Not Enrolling
Both
Recurrent Pediatric ALL, Relapsed Pediatric ALL, Acute Lymphoblastic Leukemia, Refractory Pediatric ALL

Thank you

Trial Information

A Phase I/II Trial of ABT-751 Combined With Dexamethasone, PEG-asparaginase, and Doxorubicin in Relapsed Acute Lymphoblastic Leukemia (ALL)


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose Limiting Toxicity

Outcome Time Frame:

Each dose level is evaluated

Safety Issue:

Yes

Principal Investigator

Paul S Gaynon, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Childrens Hospital Los Angeles, Therapeutic Advances in Childhood Leukemia Consortium

Authority:

United States: Food and Drug Administration

Study ID:

T2005-001

NCT ID:

NCT00439296

Start Date:

May 2006

Completion Date:

September 2009

Related Keywords:

  • Recurrent Pediatric ALL
  • Relapsed Pediatric ALL
  • Acute Lymphoblastic Leukemia
  • Refractory Pediatric ALL
  • Acute Lymphoblastic Leukemia
  • Pediatrics
  • Relapsed
  • Recurrence
  • ABT-751
  • Therapeutic Advances in Childhood Leukemia
  • Investigational
  • Childhood
  • ALL
  • Relapsed ALL
  • Refractory ALL
  • Relapsed pediatric ALL
  • Refractory pediatric ALL
  • TACL
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

Name

Location
Stanford University Medical Center Stanford, California  94305-5408
Childrens Hospital Los Angeles Los Angeles, California  90027
City of Hope Duarte, California  91010
New York University Medical Center New York, New York  10016
Seattle Children's Hospital Seattle, Washington  98105
UCSF School of Medicine San Francisco, California  94143-0106
University of Miami Cancer Center Miami, Florida  33136
C.S. Mott Children's Hospital Ann Arbor, Michigan  48109-0914
Childrens Hospital & Clinics of Minnesota Minneapolis, Minnesota  55404-4597