Phase I/II Study of Interstitial Colloidal 32P for the Treatment of Recurrent Malignant Central Nervous System Tumors and Primary Central Nervous System Tumors With Poor Prognostic Factors
- Determine the dosimetry toxicity of interstitial colloidal phosphorus P32 (C P32) in
patients with recurrent or poor prognosis grade 4 astrocytoma.
- Determine the maximum tolerated dose of C P32 administered directly into the tumor of
- Determine the maximum tolerated fractionated dose of interstitial C P32 in these
- Determine the therapeutic response rate to the acceptable single and fractionated doses
of C P32 in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive interstitial colloidal phosphorus P32 (C P32) on day 0. Courses repeat
every 4-6 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 patients receive escalating doses of C P32 until the maximum tolerated dose
(MTD) is determined. The MTD is defined the dose at which 2 of 3 patients experience
Patients are followed at 1, 2, 4, 6, 9, 15, and 24 weeks.
PROJECTED ACCRUAL: A minimum of 12 patients will be accrued for this study.
Primary Purpose: Treatment
Stanley E. Order, MD, ScD, FACR
Center for Molecular Medicine
|Center for Molecular Medicine||Garden City, New York 11530|