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Combination Chemotherapy and Radiation Therapy in Treating Children With Acute Lymphoblastic Leukemia
This study is ongoing, but not recruiting participants.
First Received: December 10, 1999   Last Updated: May 9, 2009   History of Changes
Sponsors and Collaborators: Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004034
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. It is not yet known which treatment regimen is more effective for acute lymphoblastic leukemia.

PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of combination chemotherapy and radiation therapy in treating children who have acute lymphoblastic leukemia.


Condition Intervention Phase
Cardiac Toxicity
Leukemia
Quality of Life
Drug: asparaginase
Drug: cytarabine
Drug: dexrazoxane hydrochloride
Drug: doxorubicin hydrochloride
Drug: leucovorin calcium
Drug: mercaptopurine
Drug: methotrexate
Drug: methylprednisolone
Drug: prednisolone
Drug: prednisone
Drug: therapeutic hydrocortisone
Drug: vincristine sulfate
Procedure: quality-of-life assessment
Radiation: radiation therapy
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized
Official Title: Treatment of Childhood Acute Lymphoblastic Leukemia: Grant Application Title: Erwinia Asparaginase in Childhood Acute Leukemia

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 420
Study Start Date: January 1996
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   1 Year to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically proven acute lymphoblastic leukemia (ALL) No mature B-cell ALL (i.e., surface immunoglobulin present and L3 morphology) Standard risk disease at diagnosis defined as: 1 to 9 years at diagnosis Highest pretreatment WBC less than 50,000/mm3 No blasts on CSF cytospin No T-cell markers on lymphoblasts No anterior mediastinal mass No cranial nerve palsy High risk disease defined as any patient who fails to meet all standard risk criteria at either diagnosis or at end of induction No t(8;14) (q24;q32), t(8;22), or t(2;8) T-cell surface markers and t(8;14) (q24;q11) allowed Investigational Window eligibility: At least 30 days since prior steroid therapy No concurrent emergent mediastinal radiotherapy or intubation No septic shock No concurrent intracranial hemorrhage No clinical evidence of CNS or lung leukostasis Bilirubin less than 1.4 mg/dL

PATIENT CHARACTERISTICS: Age: 1 to 17 Performance status: Not specified Hematopoietic: See Disease Characteristics Hepatic: See Disease Characteristics Renal: Not specified Other: HIV negative

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: No prior chemotherapy Endocrine therapy: See Disease Characteristics No more than 1 week of steroids Radiotherapy: See Disease Characteristics Prior emergent radiotherapy to the mediastinum allowed Surgery: Not specified Other: Prior leukapheresis or exchange transfusion allowed, but must be completed before study

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004034

Locations
United States, Louisiana
Ochsner Clinic
New Orleans, Louisiana, United States, 70121
United States, Maine
Maine Children's Cancer Program
Portland, Maine, United States, 04101
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
University of Rochester Cancer Center
Rochester, New York, United States, 14642
Canada, Ontario
McMaster Division
Hamilton, Ontario, Canada, L8N 3Z5
Canada, Quebec
Hopital Sainte Justine
Montreal, Quebec, Canada, H3T 1C5
Laval University Medical Center
Sainte-Foy, Quebec, Canada, G1V 4G2
Puerto Rico
San Jorge Childrens Hospital
Santurce, Puerto Rico, 00912
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Study Chair: Stephen E. Sallan, MD Dana-Farber Cancer Institute
  More Information

Additional Information:
Publications:
Moghrabi A, Levy DE, Asselin B, Barr R, Clavell L, Hurwitz C, Samson Y, Schorin M, Dalton VK, Lipshultz SE, Neuberg DS, Gelber RD, Cohen HJ, Sallan SE, Silverman LB. Results of the Dana-Farber Cancer Institute ALL Consortium Protocol 95-01 for children with acute lymphoblastic leukemia. Blood. 2007 Feb 1;109(3):896-904. Epub 2006 Sep 26.
Zhou J, Goldwasser MA, Li A, Dahlberg SE, Neuberg D, Wang H, Dalton V, McBride KD, Sallan SE, Silverman LB, Gribben JG. Quantitative analysis of minimal residual disease predicts relapse in children with B-lineage acute lymphoblastic leukemia in DFCI ALL consortium protocol 95-01. Blood. 2007 May 7; [Epub ahead of print]
Loh ML, Goldwasser MA, Silverman LB, Poon WM, Vattikuti S, Cardoso A, Neuberg DS, Shannon KM, Sallan SE, Gilliland DG. Prospective analysis of TEL/AML1-positive patients treated on Dana-Farber Cancer Institute Consortium Protocol 95-01. Blood. 2006 Jun 1;107(11):4508-13. Epub 2006 Feb 21.
Li A, Goldwasser MA, Zhou J, Armstrong SA, Wang H, Dalton V, Fletcher JA, Sallan SE, Silverman LB, Gribben JG. Distinctive IGH gene segment usage and minimal residual disease detection in infant acute lymphoblastic leukaemias. Br J Haematol. 2005 Oct;131(2):185-92.
Li A, Zhou J, Wang H, et al.: Molecular analysis of T-cell receptor gene rearrangements in children with T-cell acute lymphoblast leukemia on DFCI ALL Consortium Protocol 95-01. [Abstract] Blood 104 (11): A-1084, 2004.
Silverman LB, Levy DE, Dalton VK, et al.: Outcome of Dana-Farber Cancer Institute (DFCI) Consortium protocol 95-01 for children with newly diagnosed acute lymphoblastic leukemia (ALL). [Abstract] Blood 104 (11): A-679, 2004.
Zhou J, Li A, Goldwasser MA, et al.: Quantitative analysis of minimal residual disease at the completion of induction therapy predicts relapse in children with B-lineage acute lymphoblastic leukemia in DFCI ALL Consortium protocol 95-01. [Abstract] Blood 104 (11): A-323, 2004.
Barry E, DeAngelo DJ, Neuberg D, Stevenson K, Loh ML, Asselin BL, Barr RD, Clavell LA, Hurwitz CA, Moghrabi A, Samson Y, Schorin M, Cohen HJ, Sallan SE, Silverman LB. Favorable outcome for adolescents with acute lymphoblastic leukemia treated on Dana-Farber Cancer Institute Acute Lymphoblastic Leukemia Consortium Protocols. J Clin Oncol. 2007 Mar 1;25(7):813-9.

Study ID Numbers: CDR0000066202, DFCI-95001, DFCI-FDR001197, NCI-G99-1651
Study First Received: December 10, 1999
Last Updated: May 9, 2009
ClinicalTrials.gov Identifier: NCT00004034     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
untreated childhood acute lymphoblastic leukemia
L1 childhood acute lymphoblastic leukemia
L2 childhood acute lymphoblastic leukemia
cardiac toxicity
quality of life

Study placed in the following topic categories:
Anti-Inflammatory Agents
Prednisone
Hydrocortisone
Methylprednisolone
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
6-Mercaptopurine
Hormones
Razoxane
Methotrexate
Methylprednisolone Hemisuccinate
Asparaginase
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Antineoplastic Agents, Hormonal
Vincristine
Glucocorticoids
Doxorubicin
Folic Acid
Chelating Agents
Hydrocortisone acetate
Antineoplastic Agents, Phytogenic
Acute Lymphoblastic Leukemia, Childhood
Antimetabolites
Leukemia, Lymphoid
Immunologic Factors
Folate
Quality of Life
Leucovorin

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Prednisone
Anti-Infective Agents
Hydrocortisone
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Methylprednisolone
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
6-Mercaptopurine
Hormones
Razoxane
Therapeutic Uses
Abortifacient Agents
Methotrexate
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Methylprednisolone Hemisuccinate
Asparaginase
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Antineoplastic Agents, Hormonal
Immune System Diseases
Vincristine
Abortifacient Agents, Nonsteroidal
Glucocorticoids
Doxorubicin
Neoplasms
Chelating Agents

ClinicalTrials.gov processed this record on July 02, 2009