NCT00004129

Phosphorus 32 in Treating Patients With Glioblastoma Multiforme

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Center for Molecular Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Brain and Central Nervous System Tumors

Interventions

Type	Name	Description
RADIATION	brachytherapy
RADIATION	phosphorus P32

Timeline

• Start date: 1999-09-01
• First posted: 2003-01-27
• Last updated: 2013-09-17

Locations

1 site across 1 country: United States