Phosphorus 32 in Treating Patients With Glioblastoma Multiforme
Recruitment status was: Recruiting
RATIONALE: Radioactive drugs such as phosphorus 32 may be able to kill tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of phosphorus 32 in treating patients with glioblastoma multiforme.
Brain and Central Nervous System Tumors
Radiation: phosphorus P32
|Study Design:||Primary Purpose: Treatment|
|Official Title:||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|
|Study Start Date:||September 1999|
- 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 these patients.
- Determine the maximum tolerated fractionated dose of interstitial C P32 in these patients.
- 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 dose-limiting toxicity.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004129
|United States, New York|
|Center for Molecular Medicine|
|Garden City, New York, United States, 11530|
|Study Chair:||Stanley E. Order, MD, ScD, FACR||Center for Molecular Medicine|