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A Study of a Retroviral Replicating Vector Administered to Subjects With Recurrent Malignant Glioma

Study:

A Phase 1 Ascending Dose Trial of the Safety and Tolerability of Toca 511 in Patients With Recurrent High Grade Glioma

Rationale:

n/a

Purpose:

This is a multicenter, open-label, ascending-dose trial of the safety and tolerability of increasing, single doses of Toca 511, a Retroviral Replicating Vector (RRV), administered transcranially to subjects with recurrent high grade glioma (rHGG) who have undergone surgery, radiation therapy and chemotherapy with temozolomide. Approximately 3-4 weeks following injection of the RRV, treatment with oral 5-FC will commence and will be repeated monthly for up to 6 cycles.

Study Status: Recruiting

Recruiting:
Cathy Brewer, RN 216-444-7937 BrewerC1@ccf.org

Condition Intervention Phase
Glioblastoma
Anaplastic Astrocytoma
Anaplastic Oligodendroglioma
Anaplastic Oligoastrocytoma
Biological: Toca 511
Drug: 5-FC
Phase 1/Phase 2

Verified by Tocagen Inc. November, 2012

Sponsored by: Tocagen Inc.
Information provided by: Tocagen Inc.
ClinicalTrials.gov identifier: NCT01156584

Study Type: Interventional

Study Design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States

n/a

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
  Information obtained from ClinicalTrials.gov on
Link to the current ClinicalTrials.gov record.

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