Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Phosphorus 32 in Treating Patients With Glioblastoma Multiforme

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Active	18 and over	Other	CMM-2 NCI-V99-1575, NCT00004129

Objectives

1. Determine the dosimetry toxicity of interstitial colloidal phosphorus P32 (C P32) in patients with recurrent or poor prognosis grade 4 astrocytoma.
2. Determine the maximum tolerated dose of C P32 administered directly into the tumor of these patients.
3. Determine the maximum tolerated fractionated dose of interstitial C P32 in these patients.
4. Determine the therapeutic response rate to the acceptable single and fractionated doses of C P32 in these patients.

Entry Criteria

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)

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics

Surgery:

• See Disease Characteristics

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

Expected Enrollment

A minimum of 12 patients will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

Center for Molecular Medicine

Stanley Order, MD, ScD, FACR, Protocol chair		Ph: 516-222-5190

U.S.A.
New York
	Garden City
	Center for Molecular Medicine
		Stanley Order, MD, ScD, FACR	Ph:  516-222-5190

Registry Information
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
Trial Start Date		1999-09-01
Registered in ClinicalTrials.gov		NCT00004129
Date Submitted to PDQ		1999-09-20
Information Last Verified		2008-04-04

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