Phosphorus 32 in Treating Patients With Glioblastoma Mult... | NCT00004129

Studies
Phosphorus 32 in Treating Patients With Glioblastoma Multiforme

NCT00004129

Sponsor

Center for Molecular Medicine

Status

Unknown status

Last Update Posted

Sep 17, 2013Estimated

Enrollment

12Estimated

Phase

Phase 1

Conditions

Brain and Central Nervous System Tumors

Interventions

brachytherapy
phosphorus P32

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1999

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Dec 10, 1999

First Submission Date that Met QC Criteria

Jan 26, 2003

First Posted Date

Jan 27, 2003Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 16, 2013

Last Update Posted Date

Sep 17, 2013Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

12Estimated

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Type	Description	Arm Group Labels	Other Names
brachytherapy	Radiation
phosphorus P32	Radiation

ID	Term
D016543	Central Nervous System Neoplasms
D001932	Brain Neoplasms
D005909	Glioblastoma
D018316	Gliosarcoma

ID	Term
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D009422	Nervous System Diseases

ID	Term
D001918	Brachytherapy
C000615311	Phosphorus-32

ID	Term
D011878	Radiotherapy
D013812	Therapeutics

ID	Type	Description	Link
CMM-2
NCI-V99-1575