Virus-Based Drug Therapy for Brain Tumor
(rQNestin Trial)
Trial Summary
What is the purpose of this trial?
This research study is evaluating an investigational drug, an oncolytic virus called rQNestin34.5v.2. This research study is a Phase I clinical trial, which tests the safety of an investigational drug and also tries to define the appropriate dose of the investigational drug as a possible treatment for this diagnosis of recurrent or progressive brain tumor.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop all current medications, but certain medications must be stopped before participating. For example, you must stop taking dexamethasone at least 14 days before the first treatment and antiviral medications like valacyclovir, acyclovir, or ganciclovir at least 7 days before surgery.
What data supports the effectiveness of the drug rQNestin34.5v.2 for brain tumors?
Research shows that oncolytic viruses, which are viruses engineered to target and destroy cancer cells, have been promising in treating brain tumors like gliomas. Similar viruses have been tested in clinical trials and have shown safety and some effectiveness in targeting and killing tumor cells while sparing healthy brain cells.12345
How is the virus-based drug rQNestin34.5v.2 different from other brain tumor treatments?
rQNestin34.5v.2 is unique because it uses a virus to specifically target and destroy tumor cells in the brain, while leaving healthy cells unharmed. This approach, known as oncolytic virotherapy, is different from traditional treatments like surgery or chemotherapy, which can affect both cancerous and healthy cells.13467
Research Team
E. Antonio Chiocca, MD, PhD
Principal Investigator
Brigham and Women's Hospital
Eligibility Criteria
Adults over 18 with recurrent brain tumors who've had prior radiation and chemotherapy, have a Karnofsky Performance Score ≥70, and can tolerate multiple biopsies. They must not be pregnant or breastfeeding, agree to use contraception, and have no severe infections or immune disorders. Tumors must meet specific size/location criteria.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intratumoral administration of rQNestin34.5v.2, with or without Cyclophosphamide pre-treatment, following a dose escalation design
Follow-up
Participants are monitored for safety and effectiveness after treatment, including MRI evaluations and assessments of HSV1 viremia and antibody response
Treatment Details
Interventions
- rQNestin34.5v.2
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dana-Farber Cancer Institute
Lead Sponsor
National Institutes of Health (NIH)
Collaborator
Candel Therapeutics, Inc.
Industry Sponsor