Virus Therapy for Brain Tumors
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a treatment called DNX-2401, which uses a modified cold virus to target and attack brain tumor cells in individuals with recurring high-grade glioma. Researchers aim to determine the optimal dose and monitor any side effects. The trial involves two parts: administering the virus directly into the brain tumor and, in some cases, performing surgery followed by another dose of the virus. It seeks participants with brain tumors, such as glioblastoma, that have returned and are confirmed to be growing after previous treatments. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial requires participants to stop taking other cytotoxic and non-cytotoxic drugs or radiation therapy against the tumor while enrolled. Additionally, there are specific time periods that must be observed after completing certain chemotherapies before starting the trial.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that DNX-2401, the treatment under study, is safe based on earlier studies. It has been tested in people with brain tumors, and results indicate that DNX-2401 is well-tolerated and can specifically target and attack brain cancer cells.
In one study, DNX-2401 was safe and able to multiply within tumors, allowing it to fight cancer cells without causing serious side effects. Another study tested DNX-2401 alongside another treatment, and it remained safe, suggesting that DNX-2401 does not cause harmful reactions even when combined with other treatments.
Based on these studies, DNX-2401 appears safe for people with recurring high-grade glioma. However, like any treatment, there is always a chance of side effects, which is why ongoing research and clinical trials remain important.12345Why do researchers think this study treatment might be promising?
Most treatments for brain tumors involve surgery, radiation, and chemotherapy, which can harm healthy cells and tissues. However, DNX-2401 offers a unique approach by using an oncolytic adenovirus that specifically targets and destroys cancer cells without affecting normal cells. This virus therapy is exciting because it not only attacks tumors directly but also stimulates the body's immune system to recognize and fight the cancer. Researchers are hopeful that this dual action could lead to more effective treatment outcomes and fewer side effects for brain tumor patients.
What evidence suggests that DNX-2401 might be an effective treatment for brain tumors?
Research has shown that DNX-2401, a type of virus, can effectively target and destroy glioma cells, a kind of brain cancer cell. In human studies, this virus multiplied inside the tumor, leading to the breakdown of cancer cells. The trial includes two parts: in Part I, participants receive the oncolytic adenovirus Ad5-DNX-2401 alone, while in Part II, participants receive the virus followed by surgery and an additional dose of the virus. This treatment specifically targets brain cancer cells, such as those in aggressive gliomas, while leaving healthy cells unharmed. Early findings suggest that DNX-2401 may cause tumor cells to die through virus-related processes. Although the therapy is still under study, these initial results are promising for treating recurring brain tumors.12367
Who Is on the Research Team?
Frederick F Lang
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
Adults with recurrent high-grade glioma, such as glioblastoma or astrocytoma, who have tried surgery, chemotherapy, or radiation before. They must be in good enough health to undergo endovascular treatment and have a life expectancy of at least 16 weeks. Participants need a tumor size between 1-5 cm and a Karnofsky score ≥70 (able to care for themselves). Pregnant women are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part I
Patients receive one or two infusions of BM-hMSCs-DNX-2401 intra-arterially over 20-30 minutes on day 0. Dose level 1-5 will receive 1 infusion. Dose level 6 will receive 2 infusions.
Treatment Part II
Patients receive one or two infusions of BM-hMSCs-DNX-2401 IA, depending on the highest dose tolerated in Part 1. After 2 weeks, patients undergo surgery where the tumor is removed, then receive intramural injection of BM-hMSCs-DNX-2401 into the resection cavity.
Follow-up
Participants are monitored for safety and effectiveness after treatment. Follow-up occurs on days 1, 4, 7, and 14 of month 1, every 6 weeks for 6 months, then every 8 weeks for 1 year, then every 4 months for 1 year, then every 6 months until the tumor grows back.
What Are the Treatments Tested in This Trial?
Interventions
- DNX-2401
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
DNAtrix, Inc.
Industry Sponsor