Phosphorus 32 in Treating Patients With Glioblastoma Multiforme
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|ClinicalTrials.gov Identifier: NCT00004129|
Recruitment Status : Unknown
Verified April 2008 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : January 27, 2003
Last Update Posted : September 17, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors||Radiation: brachytherapy Radiation: phosphorus P32||Phase 1|
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|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|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004129
|United States, New York|
|Center for Molecular Medicine||Recruiting|
|Garden City, New York, United States, 11530|
|Contact: Stanley E. Order, MD, ScD, FACR 516-222-5190|
|Study Chair:||Stanley E. Order, MD, ScD, FACR||Center for Molecular Medicine|