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| Sponsors and Collaborators: |
Dana-Farber Cancer Institute National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| 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 |
|
Cancer-Related Problem/Condition 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 Procedure: radiation therapy |
Phase III |
| MedlinePlus related topics: | Cancer Leukemia, Childhood |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label |
| Official Title: | Treatment of Acute Lymphoblastic Leukemia in Children |
| Estimated Enrollment: | 544 |
| Study Start Date: | April 2005 |
| Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
Arm I: Active Comparator
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
Procedure: radiation therapy
Some patients may undergo cranial radiotherapy
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Arm II: Experimental
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
Procedure: radiation therapy
Some patients may undergo cranial radiotherapy
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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 | |||||
| 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 | |||||
| Centre de Recherche du Centre Hospitalier de l'Universite Laval | Recruiting | ||||
| Sainte Foy, Quebec, Canada, GIV 4G2 | |||||
| Contact: Yvan Samson, MD 418-656-4141 | |||||
| Hopital Sainte Justine | Recruiting | ||||
| Montreal, Quebec, Canada, H3T 1C5 | |||||
| Contact: Albert Moghrabi, MD 514-345-4969 albert.moghrabi@umontreal.ca | |||||
| Puerto Rico | |||||
| San Jorge Children's Hospital | Recruiting | ||||
| Santurce, Puerto Rico, 00912 | |||||
| Contact: Luis A. Clavell, MD 787-726-0316 luis.clavell@sjcms.com | |||||
| Dana-Farber Cancer Institute |
| National Cancer Institute (NCI) |
| Principal Investigator: | Lewis B. Silverman, MD | Dana-Farber Cancer Institute |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Responsible Party: | Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute ( Lewis Barry Silverman ) |
| Study ID Numbers: | CDR0000513019, DFCI-05001 |
| First Received: | November 16, 2006 |
| Last Updated: | November 21, 2008 |
| ClinicalTrials.gov Identifier: | NCT00400946 |
| Health Authority: | Unspecified |
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