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Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00671034 |
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 more than one drug (combination chemotherapy) may kill more cancer cells.
PURPOSE: This randomized clinical trial is studying giving EZN-2285 together with combination chemotherapy to see how well it works compared with giving pegaspargase together with combination chemotherapy in treating younger patients with newly diagnosed high-risk acute lymphoblastic leukemia.
Condition | Intervention |
Leukemia |
Drug: SC-PEG E. coli L-asparaginase Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: methotrexate Drug: pegaspargase Drug: prednisone Drug: vincristine sulfate Procedure: radiation therapy |
MedlinePlus related topics: | Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label |
Official Title: | A Pilot Study of Intravenous EZN-2285 (SC-PEG E. Coli L-Asparaginase, IND# 100594) or Intravenous Oncaspar® in the Treatment of Patients With High-Risk Acute Lymphoblastic Leukemia |
Estimated Enrollment: | 123 |
Study Start Date: | July 2008 |
Estimated Primary Completion Date: | March 2018 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
Arm I: Experimental
Patients receive SC-PEG E. coli L-asparaginase (EZN-2285) together with combination chemotherapy. Patients receive chemotherapy by mouth, infusion, injection, and intrathecally. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 4 years.
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Drug: SC-PEG E. coli L-asparaginase
Given IV
Drug: cyclophosphamide
All drugs are given IV
Drug: cytarabine
Given IV, intrathecally, and subcutaneously
Drug: daunorubicin hydrochloride
All drugs are given IV
Drug: dexamethasone
Both are given IV or orally
Drug: doxorubicin hydrochloride
All drugs are given IV
Drug: methotrexate
Given IV, intrathecally, and orally
Drug: prednisone
Both are given IV or orally
Drug: vincristine sulfate
All drugs are given IV
Procedure: radiation therapy
Some patients undergo cranial radiotherapy
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Arm II: Active Comparator
Patients receive pegaspargase together with combination chemotherapy. Patients receive chemotherapy by mouth, infusion, injection, and intrathecally. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 4 years.
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Drug: cyclophosphamide
All drugs are given IV
Drug: cytarabine
Given IV, intrathecally, and subcutaneously
Drug: daunorubicin hydrochloride
All drugs are given IV
Drug: dexamethasone
Both are given IV or orally
Drug: doxorubicin hydrochloride
All drugs are given IV
Drug: methotrexate
Given IV, intrathecally, and orally
Drug: pegaspargase
Given IV
Drug: prednisone
Both are given IV or orally
Drug: vincristine sulfate
All drugs are given IV
Procedure: radiation therapy
Some patients undergo cranial radiotherapy
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Show Detailed Description |
Ages Eligible for Study: | 1 Year to 30 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, California | |||||
Children's Hospital of Orange County | Recruiting | ||||
Orange, California, United States, 92868 | |||||
Contact: Violet Shen 714-532-8636 | |||||
Stanford Cancer Center | Recruiting | ||||
Stanford, California, United States, 94305-5824 | |||||
Contact: Clinical Trials Office - Stanford Cancer Center 650-498-7061 cctoffice@stanford.edu | |||||
United States, Colorado | |||||
Children's Hospital Center for Cancer and Blood Disorders | Recruiting | ||||
Aurora, Colorado, United States, 80045 | |||||
Contact: Kelly Maloney 720-777-6673 | |||||
United States, Connecticut | |||||
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center | Recruiting | ||||
Farmington, Connecticut, United States, 06360-2875 | |||||
Contact: Clinical Trials Office - Carole and Ray Neag Comprehensive Can 800-579-7822 | |||||
United States, District of Columbia | |||||
Children's National Medical Center | Recruiting | ||||
Washington, District of Columbia, United States, 20010-2970 | |||||
Contact: Clinical Trials Office - Children's National Medical Center 202-884-2549 | |||||
United States, Indiana | |||||
Indiana University Melvin and Bren Simon Cancer Center | Recruiting | ||||
Indianapolis, Indiana, United States, 46202-5289 | |||||
Contact: Clinical Trials Office - Indiana University Cancer Center 317-274-2552 | |||||
United States, Maryland | |||||
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting | ||||
Baltimore, Maryland, United States, 21231-2410 | |||||
Contact: Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce 410-955-8804 jhcccro@jhmi.edu | |||||
United States, Missouri | |||||
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | Recruiting | ||||
St. Louis, Missouri, United States, 63110 | |||||
Contact: Robert J. Hayashi 314-454-4118 | |||||
United States, Oregon | |||||
Oregon Health and Science University Cancer Institute | Recruiting | ||||
Portland, Oregon, United States, 97239-3098 | |||||
Contact: Clinical Trials Office - Oregon Health and Science University 503-494-1080 trials@ohsu.edu | |||||
United States, Pennsylvania | |||||
Children's Hospital of Pittsburgh | Recruiting | ||||
Pittsburgh, Pennsylvania, United States, 15213 | |||||
Contact: Clinical Trials Office - Children's Hospital of Pittsburgh 412-692-5573 |
Children's Oncology Group |
National Cancer Institute (NCI) |
Study Chair: | Anne Angiolillo, MD | Childrens Research Institute |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000594340, COG-AALL07P4 |
First Received: | May 1, 2008 |
Last Updated: | October 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00671034 |
Health Authority: | Unspecified |
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