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Phosphorus 32 in Treating Patients With Glioblastoma Multiforme



Phosphorus 32 in Treating Patients With Glioblastoma Multiforme

For Condition: recurrent adult brain tumor,adult glioblastoma multiforme
Status: Recruiting
Sponsor(s): Center for Molecular Medicine ,
Synopsis: RATIONALE: Radioactive drugs such as phosphorus 32 may be able to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of phosphorus 32 in treating patients who have glioblastoma multiforme.
Details: 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.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol 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) 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
StanleyOrder,  Study Chair,  Center for Molecular Medicine

Center for Molecular Medicine *Recruiting*
Garden City,  New York,  11530
United States
Recruiting Mitchell  Levine 516-222-2727


Additional Information:
Study ID Numbers:
  CDR0000067357;  CMM-2,NCI-V99-1575
Study Start Date: 
Record last reviewed: June 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004129

Other Adult Glioblastoma Multiforme Studies:
1. Radiation Therapy Followed by Bleomycin in Treating Adult Patients With Newly Diagnosed Supratentorial Glioblastoma Multiforme

2. Boron Neutron Capture Therapy in Treating Patients With Glioblastoma Multiforme or Melanoma Metastatic to the Brain

3. High-Dose Methotrexate and Leucovorin Followed By Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

4. Vaccine Therapy in Treating Patients With Malignant Glioma

5. CCI-779 in Treating Patients With Malignant Glioma

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