Phosphorus 32 in Treating Patients With Glioblastoma Multiforme
NCT ID: NCT00004129
Last Updated: 2013-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
12 participants
INTERVENTIONAL
1999-09-30
Brief Summary
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PURPOSE: This phase I trial is studying the side effects and best dose of phosphorus 32 in treating patients with glioblastoma multiforme.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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brachytherapy
phosphorus P32
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Center for Molecular Medicine
OTHER
Principal Investigators
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Stanley E. Order, MD, ScD, FACR
Role: STUDY_CHAIR
Center for Molecular Medicine
Locations
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Center for Molecular Medicine
Garden City, New York, United States
Countries
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Facility Contacts
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Stanley E. Order, MD, ScD, FACR
Role: primary
Other Identifiers
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CMM-2
Identifier Type: -
Identifier Source: secondary_id
NCI-V99-1575
Identifier Type: -
Identifier Source: secondary_id
CDR0000067357
Identifier Type: -
Identifier Source: org_study_id