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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gesellschaft fur Padiatrische Onkologie und Hamatologie - Germany
• Treatments: Cisplatin; Etoposide; Etoposide phosphate; Ifosfamide; Isophosphamide mustard; Lomustine; Methotrexate; Prednisone; Vincristine

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