Phosphorus 32 in Treating Patients With Glioblastoma Multiforme

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
National Cancer Institute (NCI)

December 10, 1999
January 27, 2003
September 17, 2013
September 1999
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Complete list of historical versions of study NCT00004129 on Archive Site
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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

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.


  • 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.

Phase 1
Primary Purpose: Treatment
Brain and Central Nervous System Tumors
  • Radiation: brachytherapy
  • Radiation: phosphorus P32
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
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  • Histologically proven grade 4 astrocytoma (glioblastoma)

    • Failed external beam radiotherapy and/or surgery OR
    • Poor prognosis disease
  • No clinical evidence of metastatic disease within the CNS other than the primary tumor site
  • Stereotactic biopsy or gross total excision with residual tumor
  • Lesion 3 to 5 cm in size
  • No spinal cord tumor(s)



  • 18 and over

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • Not specified


  • WBC at least 3,000/mm3
  • Neutrophil count at least 1,900/mm3
  • Platelet count at least 100,000/mm3
  • Hemoglobin at least 9 g/dL (transfusion allowed)


  • Not specified


  • Creatinine no greater than 1.5 mg/dL
  • BUN less than 25 mg/dL


  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy:

  • Not specified


  • Not specified

Endocrine therapy:

  • Not specified


  • See Disease Characteristics


  • See Disease Characteristics
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Center for Molecular Medicine
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Study Chair: Stanley E. Order, MD, ScD, FACR Center for Molecular Medicine
National Cancer Institute (NCI)
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP