Phosphorus 32 in Treating Patients With Glioblastoma Multiforme

Center for Molecular Medicine

Status and phase: Unknown; Phase 1

Conditions: Brain and Central Nervous System Tumors

Treatments: Radiation: brachytherapy; Radiation: phosphorus P32

Study type: Interventional

Funder types: Other

Identifiers

NCT00004129

NCI-V99-1575

CMM-2

CDR0000067357

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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