Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Duke University
With
National Cancer Institute (NCI)
OBJECTIVES:
* Determine the activity of carmustine and O6-benzylguanine in patients with newly diagnosed supratentorial glioblastoma multiforme not requiring immediate radiotherapy.
* Determine the toxicity of this regimen in these patients.
OUTLINE: Patients receive O6-benzylguanine IV over 1 hour followed approximately 1 hour later by carmustine IV over 1 hour on day 1. Treatment repeats every 6 weeks for a maximum of 3 courses in the absence of disease progression or unacceptable toxicity. Patients are then referred for radiotherapy. Patients who demonstrate tumor response after completion of the third course of chemotherapy receive 6 additional courses after completion of radiotherapy.
PROJECTED ACCRUAL: A total of 19-36 patients will be accrued for this study.
Measurable residual disease on a contrast-enhanced MRI or CT scan (for patients with a medical contraindication for MRI) with a baseline scan obtained at the corticosteroid dose the patient is receiving on the day of treatment
PATIENT CHARACTERISTICS:
Age
18 and over
Performance status
Karnofsky 60-100%
Life expectancy
Not specified
Hematopoietic
Absolute granulocyte count at least 1,500/mm3
Platelet count at least 100,000/mm3
Hemoglobin greater than 10 g/dL
Hepatic
Bilirubin normal
SGOT no greater than 2.5 times upper limit of normal
Renal
Creatinine no greater than 1.5 mg/dL
BUN no greater than 25 mg/dL
Pulmonary
DLCO greater than 75% predicted
Other
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 2 months after study
PRIOR CONCURRENT THERAPY:
Biologic therapy
Not specified
Chemotherapy
Not specified
Endocrine therapy
See Disease Characteristics
Concurrent corticosteroids allowed if on stable dose for 3 days before study
Radiotherapy
See Disease Characteristics
Surgery
No more than 28 days since prior surgical resection or biopsy
Clareo Health | Carmustine and O(6)-Benzylguanine in Treating Patients With Newly Diagnosed Supratentorial Glioblastoma Multiforme
