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A P1 Ascending Dose Trial of the Safety and Tolerability of Toca 511, a Retroviral Replicating Vector, Administered to Subjects at the Time of Resection for Recurrent High Grade Glioma and Followed by Treatment With Toca FC, Extended-Release 5-FC


Phase 1
18 Years
80 Years
Open (Enrolling)
Both
Glioblastoma Multiforme, Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, Anaplastic Oligoastrocytoma

Thank you

Trial Information

A P1 Ascending Dose Trial of the Safety and Tolerability of Toca 511, a Retroviral Replicating Vector, Administered to Subjects at the Time of Resection for Recurrent High Grade Glioma and Followed by Treatment With Toca FC, Extended-Release 5-FC

Inclusion Criteria


Inclusion Criteria (must all be answered "Yes"):

- Has the subject given written informed consent?

- Is the subject between 18 and 80 years old inclusive?

- Has the subject undergone at least one prior surgical gross-total or subtotal tumor
resection and a course of postoperative radiation therapy with concurrent
temozolomide?

- Does the subject have a single tumor recurrence/progression that is < or = 6 cm in
its greatest dimension?

- Based on pre-operative evaluation, is the tumor recurrence/progression a candidate
for a resection of at least 80%?

- Has the subject elected not to undergo treatment with the Gliadel wafer?

- Does the subject have a Karnofsky performance status of at least 70%?

- Does the subjet have an absolute neutrophil count of at least 1500/mm^3?

- Does the subject have an absolute lymphocyte count of at least 500/mm^3?

- Does the subject have a platelet count of at least 100,000/mm^3?

- Does the subject have a Hgb of at least 10 g/dL?

- Does the subject have a normal PT/PTT?

- Does the subject have an estimated glomerular filtration rate of at least 50 mL/min
by the Cockcroft-Gault formula?

- Does the subject have an ALT/AST < 3 times the upper limit of the lab reference range
and a total bilirubin < 1.5 mg/dL?

- If the subject is a female of childbearing potential, has she had a negative serum
pregnancy test within the past 21 days?

- For males and females, is the subject willing to use condoms for contraception for 6
months or until vector is no longer detected, whichever is longer?

- Is the subject willing and able to abide by the protocol?

Exclusion Criteria (must all be answered "No"):

- Has the subject received cytotoxic chemotherapy within the past 3 weeks (6 weeks for
nitrosoureas) of the planned surgery date?

- Does the subject have, or has the subject had, within the past 4 weeks an infection
requiring antibiotic, antifungal or antiviral therapy?

- Does the subject have any bleeding diathesis, or must the subject take any
anticoagulants, or antiplatelet agents, including NSAIDs, that cannot be stopped for
surgery?

- Does the subject have a history of allergy or intolerance to flucytosine?

- Is the subject HIV positive?

- Does the subject have any gastrointestinal disease that would prevent him/her from
bing able to ingest or absorb flucytosine?

- Has the subject received any investigational treatment within the past 30 days?

- Is the subject breast feeding?

- Has the subject received Avastin (bevacizumab) for this recurrence/progression,
within the past 5 weeks?

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Dose Limiting Toxicities

Outcome Description:

Excluding nausea, vomiting and fatigue, 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 511/5-FC combination.

Outcome Time Frame:

2 months

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

Tg 511-11-01

NCT ID:

NCT01470794

Start Date:

January 2012

Completion Date:

December 2013

Related Keywords:

  • Glioblastoma Multiforme
  • Anaplastic Astrocytoma
  • Anaplastic Oligodendroglioma
  • Anaplastic Oligoastrocytoma
  • GBM
  • HGG
  • High grade glioma
  • Malignant glioma
  • Grade III glioma
  • Grad IV glioma
  • Astrocytoma
  • Brain Neoplasms
  • Glioblastoma
  • Oligodendroglioma

Name

Location

Cleveland Clinic Foundation Cleveland, Ohio  44195
Henry Ford Hospital Detroit, Michigan  48202
University of California at San Diego La Jolla, California  92093
Ohio State University Columbus, Ohio  43210
UCLA Los Angeles, California  90095
JFK Medical Center Edison, New Jersey  08818
Swedish Neuroscience Institute Seattle, Washington  98122