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
18 Years
N/A
Both
Brain and Central Nervous System Tumors
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Stanley E. Order, MD, ScD, FACR
Investigator Role:
Study Chair
Investigator Affiliation:
Center for Molecular Medicine
Authority:
Unspecified
Study ID:
CDR0000067357
NCT ID:
NCT00004129
Start Date:
September 1999
Completion Date:
Related Keywords:
- Brain and Central Nervous System Tumors
- recurrent adult brain tumor
- adult glioblastoma
- adult giant cell glioblastoma
- adult gliosarcoma
- Glioblastoma
- Nervous System Neoplasms
- Central Nervous System Neoplasms
Name | Location |
|---|---|
| Center for Molecular Medicine | Garden City, New York 11530 |
