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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Brain and Central Nervous System Tumors

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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 MedicineGarden City, New York  11530