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Trial record 11 of 15 for:    "Ependymoma" | "Methotrexate"

High-Dose Methotrexate in Treating Young Patients With Solid Tumors

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: NCT00513981
Recruitment Status : Completed
First Posted : August 9, 2007
Last Update Posted : June 26, 2013
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE August 8, 2007
First Posted Date  ICMJE August 9, 2007
Last Update Posted Date June 26, 2013
Study Start Date  ICMJE March 2007
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2007)
Maximum tolerated infusion time for high-dose methotrexate
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00513981 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2007)
Plasma biochemical evidence of the systemic effect of methotrexate in terms of changes in plasma homocysteine and methionine
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE High-Dose Methotrexate in Treating Young Patients With Solid Tumors
Official Title  ICMJE Study to Determine the Maximum Tolerated Time of Infusion for High-Dose Methotrexate, Administered as a Continuous Intravenous Infusion at a Dose of 6g/m² Per 24 Hours of Infusion Time
Brief Summary

RATIONALE: Drugs used in chemotherapy, such as high-dose methotrexate work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Chemoprotective drugs, such as leucovorin calcium, may protect normal cells from the side effects of chemotherapy.

PURPOSE: This phase I trial is studying the side effects, best way to give, and best dose of high-dose methotrexate in treating patients with solid tumors.

Detailed Description


  • To determine the maximum tolerated time to exposure to high-dose methotrexate when administered as a continuous infusion at a dose of 6 g/m² per 24 hours.
  • To relate the methotrexate schedules investigated to the magnitude and duration of changes in plasma homocysteine and methionine.
  • To relate evidence of the systemic effect of methotrexate through changes in plasma homocysteine and methionine to any hepatic, neurological, or antiproliferative toxicity observed in the study group.

OUTLINE: Patients receive a continuous infusion of high-dose methotrexate IV over 24, 30, 36, or 42 hours depending on time of study entry. Beginning at hour 42 or 48, patients receive leucovorin calcium IV every 6 hours for 3 days or until plasma methotrexate concentration is < 0.2 µM. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.

Blood samples are collected at baseline and periodically during study and analyzed for pharmacodynamic effects on plasma homocysteine and methionine by gas chromatography/mass spectrometry techniques.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Brain and Central Nervous System Tumors
  • Sarcoma
  • Unspecified Childhood Solid Tumor, Protocol Specific
Intervention  ICMJE
  • Drug: leucovorin calcium
  • Drug: methotrexate
  • Other: mass spectrometry
  • Other: pharmacological study
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: August 8, 2007)
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2009
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE


  • Histologically proven malignancy, including but not limited to, any of the following:

    • Patients with MRI findings in keeping with a diffuse intrinsic pontine glioma will be eligible without histological confirmation of tumor type

      • Patients with a diagnosis of diffuse intrinsic pontine glioma who are not eligible for the erlotinib hydrochloride phase I study (CCLG-NAG-2005-09)
    • Patients with relapsed ependymoma following the CCLG phase II study of intravenous etoposide (CCLG-CNS-2001-4) or prior to this are eligible at the discretion of the physician
    • Patients with relapsed osteogenic sarcoma, other soft tissue sarcomas, or other solid tumors may be suitable for this study at the discretion of the physician
  • Radiologically evaluable disease without bone marrow involvement


Inclusion criteria:

  • Lansky performance status (PS) 30-100% (for patients ≤ 12 years of age)
  • ECOG PS ≤ 2 (for patients ≥ 13 years of age)
  • Life expectancy ≥ 9 weeks
  • ANC > 1,000/mm³
  • Platelet count > 100,000/mm³
  • Hemoglobin > 9 g/dL
  • Serum creatinine ≤ 1.5 times upper limit of normal (ULN) for age
  • Serum total bilirubin normal
  • AST or ALT ≤ 2 times ULN
  • Glomerular filtration rate ≥ 60 mL/min
  • Negative pregnancy test
  • Fertile patients must use effective contraception

Exclusion criteria:

  • Poor medical risk because of nonmalignant systemic disease or uncontrolled infection
  • Concurrent malignancies at other sites


Inclusion criteria:

  • Prophylactic trimethoprim-sulfamethoxazole must be stopped 1 week prior to methotrexate administration

Exclusion criteria:

  • Received chemotherapy or biologic therapy within the past 4 weeks
  • Received radiotherapy within the past 6 weeks
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Ireland,   United Kingdom
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00513981
Other Study ID Numbers  ICMJE CCLG-NAG-2005-13
CDR0000560133 ( Registry Identifier: PDQ (Physician Data Query) )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Children's Cancer and Leukaemia Group
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eddy J. Estlin Royal Manchester Children's Hospital
PRS Account National Cancer Institute (NCI)
Verification Date June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP