Last updated on February 2018

A Study of Toca 511 a Retroviral Replicating Vector Combined With Toca FC in Patients With Solid Tumors or Lymphoma (Toca 6)

Brief description of study

The purpose of this trial is to evaluate changes in immune activity relative to baseline following treatment with Toca 511 and Toca FC in patients with solid tumors (including recurrent high grade glioma [rHGG]) or lymphoma. This is a multicenter, open-label study of Toca 511 and Toca FC. Patients with advanced solid tumors or lymphoma, for whom curative options are not available, will be enrolled into the study, subject to all entry criteria. Tumors must be accessible to biopsy and/or resection. Patients will be qualified based on the presence of specific molecular characteristics, documented by Foundation Medicine (or equivalent) genomic profile report, and specific tumor types.

Toca 511 will be administered by IV injection followed by (1) intratumoral injection following biopsy or (2) injection into the resection cavity wall following planned resection in the case of rHGG or brain metastases. Toca FC will be administered orally in cycles of therapy.

Patients not undergoing resection of brain tumors will undergo 2 biopsies to allow assessment of baseline and follow-up immune activity in the tumor. Changes in immune activity in peripheral blood will be measured in all patients.

Clinical Study Identifier: NCT02576665

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Jamie Merchan, MD

University of Miami
Miami, FL United States
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Gerald Falchook, MD

Sarah Cannon Research Institute
Denver, CO United States
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Tarak Bhatt, MHA, PT

MD Anderson Cancer Center
Houston, TX United States
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