Phosphorus 32 in Treating Patients With Glioblastoma Multiforme - Tabular View

Tracking Information

First Received Date ^ICMJE

December 10, 1999

Last Updated Date

February 6, 2009

Start Date ^ICMJE

September 1999

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00004129 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Phosphorus 32 in Treating Patients With Glioblastoma Multiforme

Official Title ^ICMJE

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

Brief Summary

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.

Detailed 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.

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment

Condition ^ICMJE

Brain and Central Nervous System Tumors

Intervention ^ICMJE

Radiation: brachytherapy
Radiation: phosphorus P32

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00004129

Responsible Party

Study ID Numbers ^ICMJE

CDR0000067357, CMM-2, NCI-V99-1575

Study Sponsor ^ICMJE

Center for Molecular Medicine

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Stanley E. Order, MD, ScD, FACR

Center for Molecular Medicine

Information Provided By

National Cancer Institute (NCI)

Verification Date

April 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP