A Study of Toca 511, a Retroviral Replicating Vector, Combined With Toca FC in Patients With Solid Tumors or Lymphoma (Toca 6)
|ClinicalTrials.gov Identifier: NCT02576665|
Recruitment Status : Active, not recruiting
First Posted : October 15, 2015
Last Update Posted : August 24, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Triple Negative Breast Cancer Pancreatic Cancer Non-Small Cell Lung Cancer Head and Neck Cancer Ovarian Cancer Lymphoma Sarcoma Bladder Cancer Melanoma IDH1 Mutated Solid Tumors IDH1 Mutated or MGMT Methylated Recurrent HGG (Not Recruiting)||Biological: Toca 511 Drug: Toca FC||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1b Study of Toca 511, a Retroviral Replicating Vector, Combined With Toca FC in Patients With Solid Tumors or Lymphoma|
|Actual Study Start Date :||July 2016|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||November 2019|
Experimental: Toca 511/Toca FC
Toca 511: 14 mL intravenously daily for 3 days followed by up to 4 mL intratumorally or into resection cavity walls following biopsy or resection. Cutaneous melanoma patients may receive intralesional injections (up to 4 mL) daily for 5 days.
Toca FC: 220 mg/kg/day orally starting at Week 5-6. Cycles are 5- to 7- day courses of treatment every 4 to 6 weeks.
Biological: Toca 511
Toca 511 consists of a purified retroviral replicating vector encoding a modified yeast cytosine deaminase (CD) gene. The CD gene converts the antifungal 5-fluorocytosine (5FC) to the anticancer drug 5-FU in cells that have been infected by the Toca 511 vector
Drug: Toca FC
Toca FC is an extended-release formulation of flucytosine. Toca FC is supplied as 500 mg white, oblong tablets with "TOCA FC" embossed on one side and "500" embossed on the other side
- Changes from baseline in immune activity in tumor and peripheral blood [ Time Frame: Baseline to Weeks 9-10 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02576665
|United States, Colorado|
|Sarah Cannon Research Institute|
|Denver, Colorado, United States, 80218|
|United States, Florida|
|University of Miami|
|Miami, Florida, United States, 33136|
|United States, Texas|
|MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Jaime R Merchan, MD||University of Miami|