Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Information provided by:
Memorial Sloan-Kettering Cancer Center Identifier:
First received: November 1, 1999
Last updated: March 6, 2013
Last verified: March 2013

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 Intervention Phase
Drug: leucovorin calcium
Drug: trimetrexate glucuronate
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Trial of Trimetrexate and Leucovorin in The Treatment of Recurrent Childhood Acute Lymphoblastic Leukemia

Resource links provided by NLM:

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Estimated Enrollment: 25
Study Start Date: January 1996
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00002738

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Study Chair: Tanya Trippett, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided Identifier: NCT00002738     History of Changes
Other Study ID Numbers: 95-093, P30CA008748, MSKCC-95093, NCI-V96-0840
Study First Received: November 1, 1999
Last Updated: March 6, 2013
Health Authority: United States: Federal Government

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:
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Anti-Infective Agents
Antifungal Agents
Antimetabolites, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses processed this record on November 27, 2014