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Phase I Trial of Arsenic Trioxide and Stereotactic Radiotherapy for Recurrent Malignant Glioma

NCT00185861 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2009-04-09

No results posted yet for this study

Summary

To investigate the safety of delivering arsenic trioxide (ATO) in combination with stereotactic radiotherapy in recurrent malignant glioma by performing an open label, Phase I dose escalation trial. Results from this study will provide a basis for further study of ATO combined with radiation therapy as a radiosensitizer for malignant brain tumors in future Phase II studies.

Conditions

Interventions

DRUG

Arsenic Trioxide

PROCEDURE

Stereotactic radiosurgery

Sponsors & Collaborators

  • Cephalon

    collaborator INDUSTRY

  • CTI BioPharma

    collaborator INDUSTRY

  • Stanford University

    lead OTHER

Principal Investigators

  • Iris Catrice Gibbs · Stanford University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-12-31
Primary Completion
2008-01-31
Completion
2009-04-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00185861 on ClinicalTrials.gov