NCT00004129

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1999

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 10, 1999

Completed
3.1 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

September 17, 2013

Status Verified

April 1, 2008

First QC Date

December 10, 1999

Last Update Submit

September 16, 2013

Conditions

Brain and Central Nervous System Tumors

Keywords

recurrent adult brain tumoradult glioblastomaadult giant cell glioblastomaadult gliosarcoma

Interventions

brachytherapyRADIATION
phosphorus P32RADIATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Center for Molecular Medicine

Garden City, New York, 11530, United States

RECRUITING

MeSH Terms

Conditions

Central Nervous System NeoplasmsBrain NeoplasmsGlioblastomaGliosarcoma

Interventions

BrachytherapyPhosphorus-32

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesBrain DiseasesCentral Nervous System DiseasesAstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeutics

Study Officials

  • Stanley E. Order, MD, ScD, FACR

    Center for Molecular Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 10, 1999

First Posted

January 27, 2003

Study Start

September 1, 1999

Last Updated

September 17, 2013

Record last verified: 2008-04

Locations

US(1)