Garden City, New York 11530


Purpose:

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.


Study summary:

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.


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) 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


NCT ID:

NCT00004129


Primary Contact:

Study Chair
Stanley E. Order, MD, ScD, FACR
Center for Molecular Medicine


Backup Contact:

N/A


Location Contact:

Garden City, New York 11530
United States

Stanley E. Order, MD, ScD, FACR
Phone: 516-222-5190

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: October 22, 2017

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