Phosphorus 32 in Treating Patients With Glioblastoma Multiforme

Brain and Central Nervous System Tumors Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Nervous System Neoplasms

• NCT number: NCT00004129
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Recruiting
• Phase: Phase 1
• Start date: September 1999