Brain Tumors
A Trial Of Intensive Chemotherapy And Autologous
Stem Cell Reconstitution For Patients Between 6 And 60
Years Of Age With Non-Progressive Glioblastoma Multiforme
Or Diffuse Intrinsic Brain Stem Tumors, Following Initial
Local-Field Irradiation.
In collaboration with Memorial Sloan-Kettering
Cancer Center.
Objectives:
- To estimate the overall survival, progression-free
survival, and time to progression in patients with
nondisseminated glioblastoma multiforme or diffuse
intrinsic brain stem tumors treated with intensive
chemotherapy followed by autologous stem cell
reconstitution following local field irradiation.
- To assess the toxicity of this treatment in newly
diagnosed patients previously treated with local
radiation therapy.
Eligibility:
- Patients between the ages of 6 and 60 with
biopsy-proven glioblastoma multiforme or patients with
unbiopsied diffuse intrinsic brain stem tumors are
eligible.
- Patients between the ages of 6 and 60 with
biopsy-proven anaplastic astrocytoma of which 90% or less
of the tumor is excised at surgery are eligible.
- Patients must not have evidence of spinal
leptomeningeal dissemination by radiographic evaluation,
but may have positive cerebrospinal fluid cytology in the
absence of radiographic evidence of spinal leptomeningeal
dissemination.
- Patients with extraneural metastases at diagnosis
will be ineligible.
- Patients with disease progression following radical
surgery and local radiotherapy are not eligible. Patients
with stable disease or better will be eligible and
patients with residual tumor mass following radiotherapy
should be strongly considered for second surgical
debulking prior to high-dose chemotherapy.
- Patients must have a Karnofsky performance status of
at least 60%.
- Patients must have adequate hepatic, renal, cardiac,
and coagulation function.
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