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A Study of Bortezomib With Chemotherapy for Relapsed/Refractory Acute Lymphoblastic Leukemia


Phase 1/Phase 2
1 Year
21 Years
Not Enrolling
Both
Acute Lymphoblastic Leukemia

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Trial Information

A Study of Bortezomib With Chemotherapy for Relapsed/Refractory Acute Lymphoblastic Leukemia


All patients will receive 1 course of chemotherapy unless medical complications prevent the
administration of some of the drugs. Treatment will last about 1 month.

Treatment on this study will consist of a combination of 7 anti-cancer medications. The 7
anti-cancer medicines are bortezomib, vincristine, dexamethasone, PEG-asparaginase,
doxorubicin, cytarabine (Ara-C), and methotrexate (MTX).

If you are in the Phase I portion of this study, you will be given an assigned dose of
bortezomib. The dose of bortezomib will be based on doses given in previous studies done
with adults and children. At each dose level of bortezomib, between 3 and 6 children will
receive bortezomib 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 bortezomib
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 greater than 1 year and less than 21 years of age to participate in
this study.

- Patients must have relapsed acute lymphoblastic leukemia (ALL) with or without
evidence of central nervous system (CNS) disease.

- Patients must have adequate kidney, heart, and liver function.

Exclusion Criteria:

- Patients who are pregnant or breast feeding.

- Patients who have an allergy to asparaginase products

- 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

Yoav Messinger, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Children's Hospital and Clinics of Minnesota

Authority:

United States: Institutional Review Board

Study ID:

T2005-003

NCT ID:

NCT00440726

Start Date:

June 2006

Completion Date:

Related Keywords:

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

Name

Location

Stanford University Medical CenterStanford, California  94305-5408
Childrens Hospital Los AngelesLos Angeles, California  90027
City of HopeDuarte, California  91010
New York University Medical CenterNew York, New York  10016
Seattle Children's HospitalSeattle, Washington  98105
UCSF School of MedicineSan Francisco, California  94143-0106
University of Miami Cancer CenterMiami, Florida  33136
C.S. Mott Children's HospitalAnn Arbor, Michigan  48109-0914
Childrens Hospital & Clinics of MinnesotaMinneapolis, Minnesota  55404-4597
Children's Hospital New York-PresbyterianNew York, New York  10032