DB107-Retroviral Replicating Vector (RRV) Combined With DB107-Flucytosine (FC) in Patients With Recurrent Glioblastoma or Anaplastic Astrocytoma

Part of paid clinical trials in Miami, Florida.

Sponsor
Ashish Shah
Study ID
NCT06264388
Phase
PHASE2
Status
Recruiting
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Conditions

  • Anaplastic Astrocytoma
  • High Grade Glioma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • DB107-RRV — DRUG
    Patients will undergo surgery to remove as much of the high-grade glioma (HHG) tumor as possible and will receive combination intravenous (IV) and adaptive repeat intratumoral delivery of DB107-RRV in the vein (IV) and in the walls of the cavity that remains where tumor is removed.
  • DB107-FC — DRUG
    Patients will start taking DB107-FC three times by mouth every day for a period of seven days, which is one cycle of treatment. A cycle of treatment is medication taken on a set schedule with periods of rest in between. Patients will wait five weeks before taking the next seven day course of DB107-FC. The first dose of DB107-FC will be taken at the hospital or clinic; afterward, patients will take the doses of DB107-FC at home. Patients will take DB107-FC for up to 12 months after surgery.

Study Details

The purpose of this study is to determine if the investigational products, DB107-RRV and DB107-FC, as a combination treatment will shrink high-grade glioma (HGG) in patients with recurrent/progressive, resectable or unresectable disease and increase the time that disease is controlled.

Key Dates

Start date
May 1, 2024
Status verified
May 2026
Primary completion
May 1, 2034
Completion
May 1, 2034

Study Design

Enrollment
33 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: DB107-RRV and DB107-FC Group
    Patients will receive DB107-RRV during the tumor resection/biopsy procedure. Approximately 6 weeks after surgery, patients will start drug therapy with a 7-day oral regimen of 220 mg/kg/day DB107-FC, which is to be self-administered. This 7-day regimen, which is considered one cycle of treatment, is to be repeated every 6 weeks for up to 12 months. Patients will undergo follow up procedures for at least 5 years after last DB107-RRV treatment.

Primary Outcome Measure

Progression Free Survival [ Time Frame: Up to 24 Months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Miami HospitalMiamiFlorida33136
Leonela Wright, MSN, RN
[email protected]
305-243-0864
Ashish Shah, MD
[email protected]
305-243-6946
Ashish Shah, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Miami, FL

By research site
University of Miami Hospital· Miami, FL

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