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Trial record 26 of 49 for:    "Acute Lymphoblastic Leukemia, Childhood" | "Pegaspargase"

Bortezomib With Chemotherapy for Relapsed Pediatric Acute Lymphoblastic Leukemia (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: NCT00440726
Recruitment Status : Completed
First Posted : February 27, 2007
Last Update Posted : July 3, 2012
Information provided by (Responsible Party):
Therapeutic Advances in Childhood Leukemia Consortium

Brief Summary:

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of Bortezomib With Chemotherapy for Relapsed/Refractory Acute Lymphoblastic Leukemia
Study Start Date : June 2006
Actual Primary Completion Date : February 2011

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

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 ]
  3. 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. ]

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

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.

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): NCT00440726

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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
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
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Study Chair: Yoav Messinger, MD Children's Hospital and Clinics of Minnesota

Additional Information:
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Therapeutic Advances in Childhood Leukemia Consortium Identifier: NCT00440726     History of Changes
Other Study ID Numbers: T2005-003
First Posted: February 27, 2007    Key Record Dates
Last Update Posted: July 3, 2012
Last Verified: June 2012
Keywords provided by Therapeutic Advances in Childhood Leukemia Consortium:
Relapsed pediatric ALL
Refractory pediatric ALL
Recurrent Pediatric ALL
Acute Lymphoblastic Leukemia
Therapeutic Advances in Childhood Leukemia
Relapsed ALL
Refractory 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
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors