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| Sponsor: | Dana-Farber Cancer Institute |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by (Responsible Party): | Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00400946 |
Purpose
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known whether pegasparaginase is more effective than asparaginase when given together with combination chemotherapy in treating acute lymphoblastic leukemia.
PURPOSE: This randomized phase III trial is studying pegasparaginase to see how well it works compared with asparaginase when given together with combination chemotherapy in treating young patients with newly diagnosed acute lymphoblastic leukemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Drug/Agent Toxicity by Tissue/Organ Leukemia |
Drug: asparaginase Drug: cyclophosphamide Drug: cytarabine Drug: dexamethasone Drug: dexrazoxane hydrochloride Drug: doxorubicin hydrochloride Drug: etoposide Drug: leucovorin calcium Drug: mercaptopurine Drug: methotrexate Drug: methylprednisolone Drug: pegaspargase Drug: prednisolone Drug: therapeutic hydrocortisone Drug: vincristine sulfate Radiation: radiation therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Treatment of Acute Lymphoblastic Leukemia in Children |
| Estimated Enrollment: | 800 |
| Study Start Date: | April 2005 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm I
Patients receive combination chemotherapy intrathecally, by infusion, by mouth, and by injection for up to approximately 2 years. They also receive E. coli asparaginase intramuscularly. Some patients also undergo radiation therapy to the head once a day for 8 or 10 days.
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Drug: asparaginase
Given intramuscularly
Drug: cyclophosphamide
Given IV
Drug: cytarabine
Given IV and intrathecally
Drug: dexamethasone
Given orally
Drug: dexrazoxane hydrochloride
Given IV
Drug: doxorubicin hydrochloride
Given IV
Drug: etoposide
Given IV
Drug: leucovorin calcium
Given IV
Drug: mercaptopurine
Given orally
Drug: methotrexate
Given IV, intrathecally, and intramuscularly
Drug: methylprednisolone
Given IV
Drug: prednisolone
Given orally
Drug: therapeutic hydrocortisone
Given intrathecally
Drug: vincristine sulfate
Given IV
Radiation: radiation therapy
Some patients may undergo cranial radiotherapy
|
|
Experimental: Arm II
Patients receive combination chemotherapy intrathecally, by infusion, by mouth, and by injection for up to approximately 2 years. They also receive pegasparaginase IV. Some patients also undergo radiation therapy to the head once a day for 8 or 10 days.
|
Drug: cyclophosphamide
Given IV
Drug: cytarabine
Given IV and intrathecally
Drug: dexamethasone
Given orally
Drug: dexrazoxane hydrochloride
Given IV
Drug: doxorubicin hydrochloride
Given IV
Drug: etoposide
Given IV
Drug: leucovorin calcium
Given IV
Drug: mercaptopurine
Given orally
Drug: methotrexate
Given IV, intrathecally, and intramuscularly
Drug: methylprednisolone
Given IV
Drug: pegaspargase
Given IV
Drug: prednisolone
Given orally
Drug: therapeutic hydrocortisone
Given intrathecally
Drug: vincristine sulfate
Given IV
Radiation: radiation therapy
Some patients may undergo cranial radiotherapy
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 1 Year to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of acute lymphoblastic leukemia (ALL)
No known mature B-cell ALL, defined by the presence of any of the following:
Meets criteria for 1 of the following risk groups:
Standard-risk (SR) disease, defined by the following criteria:
No evidence of CNS leukemia, defined by all of the following:
High-risk (HR) disease, defined by any of the following criteria:
Evidence of CNS leukemia, defined by any of the following:
Presence of t(9;22)
Very high-risk (VHR) disease, defined by any of the following criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No prior therapy except steroids of ≤ 1 week in duration and/or emergent radiation therapy to the mediastinum
Contacts and Locations| United States, Massachusetts | |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Lewis B. Silverman, MD 617-632-6191 | |
| United States, New York | |
| Albert Einstein Cancer Center at Albert Einstein College of Medicine | Recruiting |
| Bronx, New York, United States, 10461 | |
| Contact: Clinical Trials Office - Albert Einstein Cancer Center at Albe 718-904-2730 aecc@aecom.yu.edu | |
| Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Clinical Trials Office - Herbert Irving Comprehensive Cancer C 212-305-8615 | |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Recruiting |
| Rochester, New York, United States, 14642 | |
| Contact: Barbara L. Asselin, MD 716-275-2981 | |
| United States, Rhode Island | |
| Hasbro Children's Hospital | Recruiting |
| Providence, Rhode Island, United States, 02903 | |
| Contact: Clinical Trials Office - Hasbro Children's Hospital 401-444-8945 | |
| United States, Virginia | |
| INOVA Fairfax Hospital | Recruiting |
| Fairfax, Virginia, United States, 22031 | |
| Contact: Marshall A. Schorin, MD 703-750-8800 | |
| Canada, Ontario | |
| McMaster Children's Hospital at Hamilton Health Sciences | Recruiting |
| Hamilton, Ontario, Canada, L8N 3Z5 | |
| Contact: Uma Athale, MD 905-521-2000 ext. 73464 | |
| Canada, Quebec | |
| Hopital Sainte Justine | Recruiting |
| Montreal, Quebec, Canada, H3T 1C5 | |
| Contact: Albert Moghrabi, MD 514-345-4969 albert.moghrabi@umontreal.ca | |
| Centre de Recherche du Centre Hospitalier de l'Universite Laval | Recruiting |
| Sainte Foy, Quebec, Canada, GIV 4G2 | |
| Contact: Bruno Michon, MD 418-656-4141 | |
| Puerto Rico | |
| San Jorge Children's Hospital | Recruiting |
| Santurce, Puerto Rico, 00912 | |
| Contact: Luis A. Clavell, MD 787-726-0316 luis.clavell@sjcms.com | |
| Principal Investigator: | Lewis B. Silverman, MD | Dana-Farber Cancer Institute |
More Information
| Responsible Party: | Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00400946 History of Changes |
| Obsolete Identifiers: | NCT00165165 |
| Other Study ID Numbers: | 05-001 / CDR0000513019, P01CA068484, P30CA006516, DFCI-05001 |
| Study First Received: | November 16, 2006 |
| Last Updated: | October 25, 2011 |
| Health Authority: | United States: Institutional Review Board |
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drug/agent toxicity by tissue/organ untreated childhood acute lymphoblastic leukemia L1 childhood acute lymphoblastic leukemia L2 childhood acute lymphoblastic leukemia T-cell childhood acute lymphoblastic leukemia |
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Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases 6-Mercaptopurine Cytarabine Methotrexate Cyclophosphamide Pegaspargase Asparaginase |
Dexamethasone Doxorubicin Etoposide Prednisolone Methylprednisolone Hemisuccinate Razoxane Vincristine BB 1101 Dexamethasone acetate Cortisol succinate Hydrocortisone acetate Methylprednisolone acetate Prednisolone acetate Hydrocortisone Methylprednisolone |