RecruitingPhase 2NCT06264388

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

A Biomarker-Guided Phase 2 Study of DB107-RRV (Retroviral Replicating Vector) Combined With DB107-Flucytosine Extended-Release Tablets in Patients With Recurrent Glioblastoma or Anaplastic Astrocytoma


Sponsor

Ashish Shah

Enrollment

33 participants

Start Date

May 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a two-part experimental treatment for recurrent high-grade brain tumors (glioblastoma or anaplastic astrocytoma). The approach uses a specially engineered virus injected into the tumor during surgery, followed by an antifungal drug (flucytosine) that converts into a cancer-killing agent inside the tumor cells. **You may be eligible if...** - You are between 18 and 75 years old - Your brain tumor (glioblastoma or anaplastic astrocytoma) has come back after initial treatment - Your tumor is visible and measurable on an MRI scan - You have completed your last chemotherapy treatment at least 4 weeks ago - You have received prior radiation therapy **You may NOT be eligible if...** - You have certain serious infections (e.g., HIV, hepatitis B or C) - You are pregnant - You have other active cancers - Your overall health is too poor to tolerate surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDB107-RRV

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.

DRUGDB107-FC

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.


Locations(1)

University of Miami Hospital

Miami, Florida, United States

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NCT06264388


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