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Combination Chemotherapy in Treating Children With Acute Lymphoblastic Leukemia, Osteosarcoma, or Non-Hodgkin's Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002738
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : March 7, 2013
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as trimetrexate glucuronate and leucovorin, use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating children with recurrent acute lymphoblastic leukemia, recurrent osteosarcoma, or refractory non-Hodgkin's lymphoma.

Condition or disease Intervention/treatment Phase
Leukemia Lymphoma Sarcoma Drug: leucovorin calcium Drug: trimetrexate glucuronate Phase 2

Detailed Description:


  • Determine the efficacy of trimetrexate glucuronate with leucovorin calcium rescue in children with recurrent acute lymphoblastic leukemia, recurrent osteogenic sarcoma, or refractory non-Hodgkin's lymphoma resistant to methotrexate.
  • Evaluate the toxicity of this treatment regimen in this patient population.

OUTLINE: Patients are stratified according to disease (acute lymphocytic leukemia, non-Hodgkin's lymphoma vs osteogenic sarcoma).

Patients receive trimetrexate glucuronate orally or IV every 12 hours on days 1-21 and oral leucovorin calcium every 12 hours on days 1-24. Treatment repeats every 4 weeks. Patients with stable or responsive disease may receive up to 4 courses of therapy.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 2 years.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Primary Purpose: Treatment
Official Title: Phase II Trial of Trimetrexate and Leucovorin in The Treatment of Recurrent Childhood Acute Lymphoblastic Leukemia
Study Start Date : January 1996
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2006

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologic evidence of one of the following malignancies that has failed conventional therapy:

    • Acute lymphoblastic leukemia
    • Non-Hodgkin's lymphoma with bone marrow involvement
    • Osteogenic sarcoma
  • In vitro transport resistance to methotrexate demonstrated by bone marrow aspirate assay



  • 21 and under at diagnosis

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 8 weeks


  • Granulocytopenia allowed with bone marrow involvement
  • Thrombocytopenia allowed with bone marrow involvement
  • Anemia allowed with bone marrow involvement


  • (unless due to disease)
  • Bilirubin no greater than 2.0 mg/dL
  • AST no greater than 100


  • Creatinine less than 1.5 mg/dL OR
  • Creatinine clearance at least 60 mL/min


  • No other serious medical illness
  • Not pregnant or nursing
  • Fertile patients must use effective contraception


Biologic therapy:

  • Prior bone marrow transplantation allowed


  • At least 1 week since prior intrathecal treatment
  • At least 2 weeks since prior systemic chemotherapy and recovered

    • At least 10 days for rapidly proliferating leukemia (i.e., WBC greater than 50,000)
  • No concurrent chemotherapy

Endocrine therapy:

  • Not specified


  • Prior radiotherapy allowed and recovered
  • No concurrent radiotherapy


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002738

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United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
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Study Chair: Tanya Trippett, MD Memorial Sloan Kettering Cancer Center
Layout table for additonal information Identifier: NCT00002738    
Other Study ID Numbers: 95-093
P30CA008748 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: March 7, 2013
Last Verified: March 2013
Keywords provided by Memorial Sloan Kettering Cancer Center:
recurrent childhood acute lymphoblastic leukemia
recurrent childhood lymphoblastic lymphoma
recurrent osteosarcoma
recurrent childhood small noncleaved cell lymphoma
recurrent childhood large cell lymphoma
Additional relevant MeSH terms:
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Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Protective Agents
Vitamin B Complex
Growth Substances
Antifungal Agents
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Folic Acid Antagonists