Bortezomib With Chemotherapy for Relapsed Pediatric Acute Lymphoblastic Leukemia (ALL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Therapeutic Advances in Childhood Leukemia Consortium
ClinicalTrials.gov Identifier:
NCT00440726
First received: February 23, 2007
Last updated: June 29, 2012
Last verified: June 2012
  Purpose

This is a Phase I/II study of a drug called bortezomib given in combination with chemotherapy drugs used to treat acute lymphoblastic leukemia (ALL) that has come back (recurred). Bortezomib is a drug that has been approved by the Food and Drug Administration (FDA) for treating adults with multiple myeloma which is a type of blood cancer. Bortezomib has been shown to cause cancer cells to die in studies done on animals (mice). Studies have been done that have shown that some adults and children with cancer have shown a response to bortezomib when it is used alone. Studies have also been done in adults to evaluate the dose of bortezomib that can be safely given in combination with other chemotherapy drugs.

The Phase I portion of this study is complete and the dose for the phase II portion of the study is 1.3mg/m2/day. The phase II portion of the study is open and accruing.


Condition Intervention Phase
Acute Lymphoblastic Leukemia
Drug: bortezomib (Velcade)
Drug: dexamethasone
Drug: PEG-asparaginase
Drug: doxorubicin
Drug: cytarabine
Drug: methotrexate
Drug: vincristine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study of Bortezomib With Chemotherapy for Relapsed/Refractory Acute Lymphoblastic Leukemia

Resource links provided by NLM:


Further study details as provided by Therapeutic Advances in Childhood Leukemia Consortium:

Primary Outcome Measures:
  • Dose limiting toxicity [ Time Frame: Each dose level is evaluated ] [ Designated as safety issue: Yes ]
  • Maximum tolerated dose [ Time Frame: Each dose level is evaluated ] [ Designated as safety issue: Yes ]
  • Rate of remission [ Time Frame: The rate of remission will be evaluated upon completion of the phase I portion and then the phase II portion. ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: June 2006
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: bortezomib (Velcade)
    Intravenous at 1.3mg/m2 on days 1, 4, 8 and 11
    Other Name: Velcade
    Drug: dexamethasone
    Intravenous or oral administration for 14 days.
    Drug: PEG-asparaginase
    Intramuscular injection
    Drug: doxorubicin
    Intravenous infusion
    Drug: cytarabine
    Intrathecal administration on day 1
    Drug: methotrexate
    Intrathecal administration
    Drug: vincristine
    Intravenous push on days 1, 8, 15, 22
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   1 Year to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00440726

Locations
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
Children's Hospital New York-Presbyterian
New York, New York, United States, 10032
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Therapeutic Advances in Childhood Leukemia Consortium
Investigators
Study Chair: Yoav Messinger, MD Children's Hospital and Clinics of Minnesota
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Therapeutic Advances in Childhood Leukemia Consortium
ClinicalTrials.gov Identifier: NCT00440726     History of Changes
Other Study ID Numbers: T2005-003
Study First Received: February 23, 2007
Last Updated: June 29, 2012
Health Authority: United States: Institutional Review Board
Canada: Health Canada
Brazil: National Committee of Ethics in Research
Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Therapeutic Advances in Childhood Leukemia Consortium:
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

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Liposomal doxorubicin
Pegaspargase
Bortezomib
Asparaginase
Cytarabine
Dexamethasone
Doxorubicin
Methotrexate
Vincristine
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents

ClinicalTrials.gov processed this record on August 28, 2014