ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
Combination Chemotherapy in Treating Children With Acute Lymphoblastic Leukemia, Osteosarcoma, or Non-Hodgkin's Lymphoma

This study is ongoing, but not recruiting participants.

Sponsored by: Memorial Sloan-Kettering Cancer Center
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002738
  Purpose

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
Leukemia
Lymphoma
Sarcoma
Drug: leucovorin calcium
Drug: trimetrexate glucuronate
Phase II

MedlinePlus related topics:   Cancer    Leukemia, Adult Acute    Leukemia, Adult Chronic    Leukemia, Childhood    Lymphoma    Soft Tissue Sarcoma   

ChemIDplus related topics:   Leucovorin Calcium    Citrovorum factor    Folinic acid calcium salt pentahydrate    Leucovorin    Calcium gluconate    Trimetrexate    Trimetrexate glucuronate   

U.S. FDA Resources

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

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

Estimated Enrollment:   25
Study Start Date:   January 1996

Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility
Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 21 and under at diagnosis

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 8 weeks

Hematopoietic:

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

Hepatic:

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

Renal:

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

Other:

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Prior bone marrow transplantation allowed

Chemotherapy:

  • 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

Radiotherapy:

  • Prior radiotherapy allowed and recovered
  • No concurrent radiotherapy

Surgery:

  • Not specified
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002738

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center    
      New York, New York, United States, 10021

Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center

Investigators
Study Chair:     Tanya Trippett, MD     Memorial Sloan-Kettering Cancer Center    
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000064649, MSKCC-95093, NCI-V96-0840
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00002738
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent childhood acute lymphoblastic leukemia  
recurrent childhood lymphoblastic lymphoma  
recurrent osteosarcoma  
recurrent childhood small noncleaved cell lymphoma  
recurrent childhood large cell lymphoma  

Study placed in the following topic categories:
Leukemia, Lymphoid
Clotrimazole
Malignant mesenchymal tumor
Miconazole
Lymphoma, small cleaved-cell, diffuse
Leucovorin
Osteogenic sarcoma
Small non-cleaved cell lymphoma
Soft tissue sarcomas
Lymphoma, large-cell
Leukemia
Lymphoma
Trimetrexate
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Tioconazole
Osteosarcoma
Lymphoblastic lymphoma
Recurrence
Folic Acid
Lymphatic Diseases
Sarcoma
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Neoplasms by Histologic Type
Vitamin B Complex
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors
Folic Acid Antagonists
Pharmacologic Actions
Neoplasms
Vitamins
Antifungal Agents
Therapeutic Uses
Micronutrients

ClinicalTrials.gov processed this record on August 20, 2008




Links to all studies - primarily for crawlers