VB-111 in Surgically Accessible Recurrent/Progressive GBM

Part of paid clinical trials in Los Angeles, California.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT04406272
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • VB11 — DRUG
    Intravenously administered type of gene therapy that works by blocking the process of blood-vessel creation. Disrupting a cancer from growing blood vessels, might slow the growth of the cancer or shrink it.
  • Surgery — PROCEDURE
    Treatment of disease or injury by cutting, abrading, suturing, or otherwise physically changing body tissues and organs.
  • Placebo — OTHER
    Intravenous solution that has no therapeutic effect, used as a control in testing investigational drug.
  • Bevacizumab — DRUG
    A type of antibody, Bevacizumab is intravenously administered and works by binding to and disrupting the vascular endothelial growth factor (VEGF). VEGF is a signal protein produced by cells that stimulates the formation of blood vessels. By disrupting VEGF, Bevacizumab helps to prevent the growth and maintenance of tumor blood vessels.

Study Details

This research study is studying a new viral cancer therapy, ofranergene obadenovec (VB-111), for recurrent or progressive glioblastoma (GBM), a brain tumor that is growing or progressing despite earlier treatment.

Key Dates

First listed
May 28, 2020
Start date
Aug 1, 2020
Status verified
May 2025
Primary completion
Aug 1, 2024
Completion
Aug 1, 2024

Study Design

Enrollment
15 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Before and After Surgery
    VB-111 will be administered intravenously at a pre-determined dose at 14-28 days prior to surgery. Upon recovering from surgery (within 28-35 days after surgery), participants will receive intravenous VB-111 every 6 weeks. Participants evidencing disease progression may initiate bevacizumab at a pre-determined dose as needed for supportive care and will continue with VB-111 infusions every 6 weeks until tumor growth is evidenced a two consecutive time points.
  • Experimental: After Surgery
    Placebo (IV solution with no medicine) will be administered intravenously at a pre-determined dose at 14-28 days prior to surgery. Upon recovering from surgery (within 28-35 days after surgery), participants will receive intravenous VB-111 every 6 weeks. Participants evidencing disease progression may initiate bevacizumab at a pre-determined dose as needed for supportive care and will continue with VB-111 infusions every 6 weeks until tumor growth is evidenced a two consecutive time points.
  • Experimental: After Surgery Standard of Care
    Placebo (IV solution with no medicine) will be administered intravenously at a pre-determined dose at 14-28 days prior to surgery. Upon recovery from surgery, participants will receive standard of care treatment every 6 weeks until tumor growth is evidenced a two consecutive time points.

Primary Outcome Measure

Tumor Infiltrating T Cell (TIL) Density [ Time Frame: 2 years ]

Locations (4)

FacilityCityStateZIPSite coordinators
University of California, Los Angeles (UCLA)Los AngelesCalifornia90095-
Dana-Farber Cancer InstituteBostonMassachusetts02115-
UT Health San Antonio MD Anderson Cancer Center (Mays Cancer Center)San AntonioTexas78229-
Huntsman Cancer Institute (HCI), University of UtahSalt Lake CityUtah84112-

Find similar trials in Los Angeles, CA

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
University of California, Los Angeles (UCLA)· Los Angeles, CADana-Farber Cancer Institute· Boston, MAUT Health San Antonio MD Anderson Cancer Center (Mays Cancer Center)· San Antonio, TXHuntsman Cancer Institute (HCI), University of Utah· Salt Lake City, UT

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