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Trial record 11 of 55 for:    "Anaplastic oligoastrocytoma"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01156584
Recruitment Status : Completed
First Posted : July 5, 2010
Last Update Posted : May 21, 2018
Information provided by (Responsible Party):
Tocagen Inc.

Tracking Information
First Submitted Date  ICMJE July 1, 2010
First Posted Date  ICMJE July 5, 2010
Last Update Posted Date May 21, 2018
Study Start Date  ICMJE July 2010
Actual Primary Completion Date August 18, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2018)
Maximum Feasible, Safe and Well Tolerated Dose of Toca 511 [ Time Frame: 8-10 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 2, 2010)
Determine the Maximum Tolerated Dose of Toca 511 [ Time Frame: 7 weeks ]
Change History Complete list of historical versions of study NCT01156584 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2018)
  • Safety and tolerability of repeated treatment with Toca FC following administration of Toca 511 [ Time Frame: 6 months ]
    Review of adverse events including laboratory safety data (specifically any Grade 3 or higher non-hematologic toxicity or any Grade 4 or higher hematologic toxicity, felt to be related to Toca 511 or the Toca 511/Toca FC combination)
  • Overall survival of Subjects [ Time Frame: Overall survivial, Overall survivial at 6 months (OS6), 9 months (OS9), and 12 months (OS12) ]
  • Evaluate progression free survival (PFS) at 6 months [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2010)
  • Determine Response Rate at MTD [ Time Frame: 6 months ]
  • Determine the PFS-6 at MTD [ Time Frame: 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE A Study of a Retroviral Replicating Vector Combined With a Prodrug Administered to Patients With Recurrent Malignant Glioma
Official Title  ICMJE A Phase 1 Ascending Dose Trial of the Safety and Tolerability of Toca 511 in Patients With Recurrent High Grade Glioma
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Glioblastoma
  • Anaplastic Astrocytoma
  • Anaplastic Oligodendroglioma
  • Anaplastic Oligoastrocytoma
Intervention  ICMJE
  • Biological: Toca 511 vector
    Single, stereotactic, transcranial, intratumoral injection or intravenous injection
    Other Names:
    • Retroviral Replicating Vector (RRV)
    • Gene Therapy
    • Gene Transfer
  • 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.
    Other Name: flucytosine, 5-FC, 5-FC XR, Toca FC (extended release flucytosine)
Study Arms  ICMJE Experimental: Single arm
Toca 511 vector/ Toca FC prodrug
  • Biological: Toca 511 vector
  • Drug: Toca FC
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 16, 2018)
Original Estimated Enrollment  ICMJE
 (submitted: July 2, 2010)
Actual Study Completion Date  ICMJE August 18, 2016
Actual Primary Completion Date August 18, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01156584
Other Study ID Numbers  ICMJE Tg 511-08-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tocagen Inc.
Study Sponsor  ICMJE Tocagen Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Asha Das, MD Tocagen Inc.
Principal Investigator: Manish Aghi, MD, NS University of California, San Francisco
PRS Account Tocagen Inc.
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP