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
brachytherapy
+ phosphorus P32
Astrocytoma+15
+ Brain Diseases
+ Central Nervous System Diseases
Treatment Study
Summary
Study start date: September 1, 1999
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.12 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Center for Molecular Medicine
Garden City, United StatesOpen Center for Molecular Medicine in Google Maps