cropped color_logo_with_background.png

Clinical Trial Finder

A Study of a Retroviral Replicating Vector Combined With a Prodrug Administered to Patients With Recurrent Malignant Glioma

Study Purpose

This is a multicenter, open-label, ascending-dose trial of the safety and tolerability of increasing doses of Toca 511, a Retroviral Replicating Vector (RRV), administered to patients with recurrent high grade glioma (rHGG) who have undergone surgery followed by adjuvant radiation therapy and chemotherapy. Patients will receive Toca 511 either via stereotactic, transcranial injection into their tumor or as an intravenous injection given daily for 3 & 5 days, depending on cohort. Approximately 3-4 weeks following injection of the RRV, treatment with Toca FC, an antifungal agent, will commence and will be repeated approximately every 6 weeks until study completion. After completion of this study, all patients will be eligible for enrollment and encouraged to enter a long-term continuation protocol that enables additional Toca FC treatment cycles to be given, as well as permits the collection of long-term safety and survival data.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - at least 18 years of age.
  • - for intratumoral cohorts, supratentorial HGG (WHO grade III or IV) - technically unresectable HGG.
  • - initial definitive therapy such as surgery with or without adjuvant radiation.
  • - subject elected not to undergo treatment with Gliadel wafer.
  • - if receiving corticosteroids, dose is stable or decreasing for past 7 days.
  • - KPS: at least 70.
  • - absolute neutrophil count > 1500/mm^3.
  • - absolute lymphocyte count > 500/mm^3.
  • - platelet count > 100,000/mm^3.
  • - hemoglobin > 10 g/dL.
  • - for intratumoral cohort, coagulation profile favorable to surgery.
  • - estimated glomerular filtration rate > 50 mL/min.
  • - ALT < 3 times ULN and bilirubin < 1.5 mg/dL.
  • - negative serum pregnancy test.

Exclusion Criteria:

  • - cytotoxic therapy within the past 4 weeks (6 weeks for BCNU/CCNU) - more than 2 recurrences including present recurrence.
  • - Gliadel wafer or wafers implanted within the past 8 weeks.
  • - taking more than 8 mg of dexamethasone per day.
  • - for intratumoral cohorts, injection of tumor would require violation of ventricular system.
  • - any infection requiring antibiotic, anticoagulant, or antiplatelet agents within the past 4 weeks.
  • - for intratumoral cohort, bleeding diathesis or use of anticoagulants/antiplatelet agents that cannot be stopped.
  • - allergy or intolerance to 5-FC.
  • - HIV positive.
  • - g.
i. condition that would prevent ingestion or absorption of 5-FC.
  • - any investigational treatment within the past 30 days.
  • - pregnant or breast feeding.
  • - received Avastin.
  • - history of prior malignancy, excluding basal or squamous cell carcinoma of the skin, with an expected survival of less than 5 years.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT01156584
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Tocagen Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Asha Das, MDManish Aghi, MD, NS
Principal Investigator Affiliation Tocagen Inc.University of California, San Francisco
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma, Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, Anaplastic Oligoastrocytoma
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Single arm

Toca 511 vector/ Toca FC prodrug

Interventions

Biological: - Toca 511 vector

Single, stereotactic, transcranial, intratumoral injection or intravenous injection

Drug: - Toca FC

4-6 week cycles of Toca FC. Doses evaluated from 120 mg/kg/day or 300 mg/kg/day. Duration of dosing evaluated: 6 days, 7 days or 14 days.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

City of Hope, Duarte, California

Status

Address

City of Hope

Duarte, California, 91010

UCLA, Los Angeles, California

Status

Address

UCLA

Los Angeles, California, 90095

UCSD, San Diego, California

Status

Address

UCSD

San Diego, California, 92093

UCSF, San Francisco, California

Status

Address

UCSF

San Francisco, California, 94143

Henry Ford Hospital, Detroit, Michigan

Status

Address

Henry Ford Hospital

Detroit, Michigan, 48202

Hackensack University Medical Center, Hackensack, New Jersey

Status

Address

Hackensack University Medical Center

Hackensack, New Jersey, 07601

Cleveland Clinic Foundation, Cleveland, Ohio

Status

Address

Cleveland Clinic Foundation

Cleveland, Ohio, 44195

The Ohio State University, Columbus, Ohio

Status

Address

The Ohio State University

Columbus, Ohio, 43210

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania

Status

Address

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232

Houston, Texas

Status

Address

The Methodist Hospital Research Institute

Houston, Texas, 77030

Powered By