We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Combination Chemotherapy and Radiation Therapy With or Without Methotrexate in Treating Young Patients With Newly Diagnosed Gliomas

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2008 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00278278
First Posted: January 18, 2006
Last Update Posted: December 19, 2013
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.
Information provided by:
National Cancer Institute (NCI)
  Purpose

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether giving methotrexate together with combination chemotherapy and radiation therapy is more effective than combination chemotherapy and radiation therapy alone in treating gliomas.

PURPOSE: This randomized phase III trial is studying giving methotrexate together with combination chemotherapy and radiation therapy to see how well it works compared to combination chemotherapy and radiation therapy alone in treating young patients with newly diagnosed gliomas.


Condition Intervention Phase
Brain and Central Nervous System Tumors Drug: cisplatin Drug: etoposide Drug: ifosfamide Drug: lomustine Drug: methotrexate Drug: prednisone Drug: vincristine sulfate Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Children and Adolescents With Diffuse Intrinsic Pontine Glioma and High Grade Glioma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Overall survival (OS) rate at 5.5 years

Secondary Outcome Measures:
  • Comparison of OS, progression-free survival, and event-free survival with historical control annually
  • Long-term sequelae annually
  • Tumor response
  • Progression-free survival
  • Event-free survival
  • Health status

Estimated Enrollment: 150
Study Start Date: September 2003
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I

Patients receive high-dose methotrexate IV over 24 hours on days 1 and 15 and leucovorin calcium IV every 6 hours on days 2-3 an 16-17. Four weeks later, patients undergo external beam radiotherapy once daily, 5 days a week, for approximately 6 weeks.

Beginning on the first day of radiotherapy, patients receive cisplatin IV over 1 hour on days 1-5, etoposide IV over 2 hours on days 1-3, and vincristine IV on days 5, 12, 19, 26, and 33. Beginning seven days prior to completion of radiotherapy, patients receive ifosfamide IV over 1 hour and cisplatin IV over 1 hour on days 1-5, etoposide IV over 2 hours on days 1-3, and vincristine IV on day 5.

Drug: cisplatin
Given IV
Drug: etoposide
Given IV
Drug: ifosfamide
Given IV
Drug: lomustine
Given IV
Drug: methotrexate
Given IV
Drug: prednisone
Given IV
Drug: vincristine sulfate
Given IV
Active Comparator: Arm II

Patients undergo external beam radiotherapy once daily, 5 days a week, for approximately 6 weeks.

Beginning on the first day of radiotherapy, patients receive cisplatin IV over 1 hour on days 1-5, etoposide IV over 2 hours on days 1-3, and vincristine IV on days 5, 12, 19, 26, and 33. Beginning seven days prior to completion of radiotherapy, patients receive ifosfamide IV over 1 hour and cisplatin IV over 1 hour on days 1-5, etoposide IV over 2 hours on days 1-3, and vincristine IV on day 5.

Drug: cisplatin
Given IV
Drug: etoposide
Given IV
Drug: ifosfamide
Given IV
Drug: lomustine
Given IV
Drug: prednisone
Given IV
Drug: vincristine sulfate
Given IV

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Newly diagnosed tumors of the brain or spinal cord, meeting one of the following criteria:

    • Histologically* confirmed diagnosis of 1 of the following high-grade gliomas:

      • Glioblastoma (WHOº IV)
      • Anaplastic astrocytoma (WHOº III)
      • Gliosarcoma (WHOº III or IV)
      • Anaplastic oligo-astrocytoma NOTE: *Histological requirement may be waived for other types of brainstem glioma
    • Radiologically proven diffuse intrinsic pontine glioma
  • Second malignancy or disseminate metastases or multifocal tumors are allowed if the field of irradiation is not too large

    • No diffuse metastases making craniospinal irradiation necessary

PATIENT CHARACTERISTICS:

  • No cardiorespiratory insufficiency requiring medical respiration
  • No low blood pressure requiring systemic catecholamines
  • No severe neurological damage (e.g., coma)
  • No tetraplegia without possibility to communicate
  • No other poor clinical condition
  • Not pregnant
  • Fertile patients must use effective contraception
  • No hypersensitivity to methotrexate, cisplatin, vincristine, lomustine, or ifosfamide
  • No other malignancy preceding radiotherapy that does not allow further radiation

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy for brain tumor
  • The following prior therapies are allowed:

    • Mistletoe
    • H15 (extract of Boswellia serrata)
    • Homeopathy therapy with dilution > 4D
    • Alternative medicine without proven efficacy
  • No prior radiotherapy for brain tumor
  • No concurrent alcohol or tobacco consumption
  • No concurrent participation in another study
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00278278


Locations
United States, Texas
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
Gesellschaft fur Padiatrische Onkologie und Hamatologie - Germany
Investigators
Study Chair: Christoph Kramm, MD University Children's Hospital
  More Information

Publications:
Responsible Party: Christoph Kramm, University Children's Hospital
ClinicalTrials.gov Identifier: NCT00278278     History of Changes
Other Study ID Numbers: CDR0000454723
GPOH-HIT-GBM-D
EU-205100
First Submitted: January 16, 2006
First Posted: January 18, 2006
Last Update Posted: December 19, 2013
Last Verified: November 2008

Keywords provided by National Cancer Institute (NCI):
untreated childhood brain stem glioma
untreated childhood cerebellar astrocytoma
childhood high-grade cerebral astrocytoma
childhood spinal cord neoplasm

Additional relevant MeSH terms:
Glioma
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Etoposide phosphate
Isophosphamide mustard
Cisplatin
Methotrexate
Prednisone
Etoposide
Vincristine
Ifosfamide
Lomustine
Antineoplastic Agents
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents