Status:
UNKNOWN
Combination Chemotherapy and Radiation Therapy With or Without Methotrexate in Treating Young Patients With Newly Diagnosed Gliomas
Lead Sponsor:
German Society for Pediatric Oncology and Hematology GPOH gGmbH
Conditions:
Brain and Central Nervous System Tumors
Eligibility:
All Genders
3-18 years
Phase:
PHASE3
Brief Summary
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 ch...
Detailed Description
OBJECTIVES: Primary * Determine if the addition of high-dose methotrexate prior to standard treatment improves survival of patients with malignant high-grade glioma or diffuse intrinsic pontine glio...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00278278
Start Date
September 1 2003
Last Update
December 19 2013
Active Locations (1)
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1
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009