Clinical trial · Interventional

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

Treatment of Children and Adolescents With Diffuse Intrinsic Pontine Glioma and High Grade Glioma

NCT00278278CI-TRIAL-00013100unknownPhase 3ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Brain and Central Nervous System Tumors	—	UNRESOLVED	—

Interventions

Interventions (7)

Intervention	Type	Mapped drug	Match
cisplatin	Drug	Cisplatin	ALIAS
etoposide	Drug	Etoposide	ALIAS
ifosfamide	Drug	Ifosfamide	ALIAS
lomustine	Drug	Lomustine	ALIAS
methotrexate	Drug	Methotrexate	ALIAS
prednisone	Drug	Prednisone	ALIAS
vincristine sulfate	Drug	Vincristine	ALIAS

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Arm I
description
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.
interventionNames
1. Drug: cisplatin
2. Drug: etoposide
3. Drug: ifosfamide
4. Drug: lomustine
5. Drug: methotrexate
6. Drug: prednisone
7. Drug: vincristine sulfate
type
ACTIVE_COMPARATOR
label
Arm II
description
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.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 3 Years
Maximum age: 18 Years

Show eligibility criteria text

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

References

Publications (1)

RESULTWolff JE, Kortmann RD, Wolff B, Pietsch T, Peters O, Schmid HJ, Rutkowski S, Warmuth-Metz M, Kramm C. High dose methotrexate for pediatric high grade glioma: results of the HIT-GBM-D pilot study. J Neurooncol. 2011 May;102(3):433-42. doi: 10.1007/s11060-010-0334-2. Epub 2010 Aug 8. PMID 20694800

Registry

Dates and enrollment

Start: Sep 1, 2003
Primary completion: Mar 1, 2010
Completion: —
First posted: Jan 18, 2006
Last update posted: Dec 19, 2013
Enrollment: 150 (estimated)
Lead sponsor: German Society for Pediatric Oncology and Hematology GPOH gGmbH OTHER
Keywords: untreated childhood brain stem glioma, untreated childhood cerebellar astrocytoma, childhood high-grade cerebral astrocytoma, childhood spinal cord neoplasm

Data updated 22 days agoSource updated Dec 19, 2013source: clinicaltrials

Locations

Locations by country (1)

Country	Sites	Recruiting
United States	1	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.