Phosphorus 32 in Treating Patients With Glioblastoma Multiforme

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00004129
First received: December 10, 1999
Last updated: September 16, 2013
Last verified: April 2008

December 10, 1999
September 16, 2013
September 1999
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Complete list of historical versions of study NCT00004129 on ClinicalTrials.gov 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.

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.

Interventional
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
12
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DISEASE CHARACTERISTICS:

  • 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)

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • Not specified

Hematopoietic:

  • 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)

Hepatic:

  • Not specified

Renal:

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

Other:

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics

Surgery:

  • See Disease Characteristics
Both
18 Years and older
No
United States
 
NCT00004129
CDR0000067357, CMM-2, NCI-V99-1575
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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