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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00004129
• Other study ID #: CDR0000067357
• Secondary ID: CMM-2NCI-V99-157
• Status: Recruiting
• Phase: Phase 1
• First received: December 10, 1999
• Last updated: September 16, 2013
• Start date: September 1999

Study information

• Verified date: April 2008
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Radiation:
• brachytherapy

• phosphorus P32

Locations

Country	Name	City	State
United States	Center for Molecular Medicine	Garden City	New York

Sponsors (1)

Lead Sponsor	Collaborator
Center for Molecular Medicine

Country where clinical trial is conducted

United States,