Bortezomib With Chemotherapy for Relapsed Pediatric Acute Lymphoblastic Leukemia (ALL)
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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 |
- 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) |
-
Drug: bortezomib (Velcade)
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 |
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| 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 | |
| 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 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 Immunologic Factors |
ClinicalTrials.gov processed this record on May 19, 2013