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A Phase 1 / 2 Dose Escalation Study of Locally-Administered OncoGel™ in Subjects With Recurrent Glioma

NCT00479765 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2022-06-22

Study results available
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Summary

OncoGel™ is a new, experimental drug delivery system that allows the slow continuous release of paclitaxel (an approved intravenous anticancer drug), from a gel (ReGel™) over a long period of time. The gel will disappear in 4 to 6 weeks as it releases the paclitaxel.

The purpose of this study is to evaluate the safety and tolerability of OncoGel when placed into the tumor resection cavity in the brain following surgical removal of the tumor. Dose escalation is conducted by gradually increasing the amount of OncoGel placed in the resection cavity in small groups of patients, and watching the patients closely for side effects before moving to the next dose level. The study will also test whether OncoGel helps to prevent or delay the tumor from regrowing.

Conditions

Interventions

DRUG

OncoGel (ReGel/Paclitaxel)

OncoGel administered into cavity after surgical resection of recurrent glioma. Each subject will receive one dose of OncoGel on the day of surgical resection.

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Maciej S Lesniak, MD · University of Chicago

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2009-10-31
Completion
2009-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00479765 on ClinicalTrials.gov