Phosphorus 32 in Treating Patients With Glioblastoma Multiforme
- Conditions
- Brain and Central Nervous System Tumors
- Registration Number
- NCT00004129
- Lead Sponsor
- Center for Molecular Medicine
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
* 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 12
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Center for Molecular Medicine
🇺🇸Garden City, New York, United States
Center for Molecular Medicine🇺🇸Garden City, New York, United StatesStanley E. Order, MD, ScD, FACRContact516-222-5190