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Virus Therapy
Therapeutic Conventional Surgery for Anaplastic Astrocytoma
Phase 1
Recruiting
Led By Frederick F Lang
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study Summary
This trial is testing a new virus treatment for brain cancer. The virus is made to only attack cancer cells, and not healthy cells.
Who is the study for?
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.Check my eligibility
What is being tested?
The trial is testing the safety and optimal dose of DNX-2401, an altered cold virus targeting brain cancer cells. It's given after conventional surgery to see if it can help treat recurrent high-grade gliomas more effectively than current treatments.See study design
What are the potential side effects?
Potential side effects may include typical cold symptoms due to the viral nature of DNX-2401 but modified not to cause infection. There could also be inflammation around the injection site in the brain and general immune reactions as the body responds to the virus attacking cancer cells.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events (AEs)
Maximum-tolerated dose (MTD)
Secondary outcome measures
Immunogenicity based on adenoviral (AdV) antibodies
Time to progression
Tumor response
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Part II (oncolytic adenovirus Ad5-DNX-2401, surgery)Experimental Treatment2 Interventions
Patients receive oncolytic adenovirus Ad5-DNX-2401 as in part I. After 2 weeks, patients undergo surgery, then receive oncolytic adenovirus Ad5-DNX-2401 IA over 20-30 minutes.
Group II: Part I (oncolytic adenovirus Ad5-DNX-2401)Experimental Treatment1 Intervention
Patients receive oncolytic adenovirus Ad5-DNX-2401 IA over 20-30 minutes on day 0.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9850
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,281 Total Patients Enrolled
DNAtrix, Inc.Industry Sponsor
7 Previous Clinical Trials
212 Total Patients Enrolled
Frederick F LangPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My tumor can be removed surgically, and I need a surgery to remove part of my skull to access it.My recurrent brain tumor does not have IDH-1 mutation and shows a significant mass on MRI.It has been at least 8 weeks since my last radiotherapy session.My IDH-mutant astrocytoma has progressed to grade 4 at recurrence with a significant mass visible on MRI.My tumor is between 1.0 cm and 5.0 cm in size.My cancer has spread to the lining of my brain and spinal cord.I have trouble getting IV lines placed for procedures.I haven't had biologic or immunotherapy in the last 2 weeks.My tumor is located in the back part of my brain.My brain tumor is not classified as GBM, gliosarcoma, IDH wild-type grade III, or IDH-mutant grade 4 astrocytoma.My cancer has spread to the lower part of my brain or outside my skull.I have a health condition that prevents me from having surgery.I agree not to take other cancer treatments while in this study.I do not have any severe infections or unstable health conditions.I don't have any health or mental conditions that would stop me from joining.I have a brain infection or condition like encephalitis or multiple sclerosis.I haven't received blood transfusions or medications for blood disorders in the last 28 days.I am mostly independent and can care for myself.My artery is less than 50% blocked and can be treated with a procedure.My cancer has returned or worsened after treatment, confirmed by an MRI.My bone marrow, liver, and kidneys are working well.I have Li-Fraumeni Syndrome or a genetic issue related to the retinoblastoma gene.My condition is recurrent GBM or gliosarcoma.I am 18 years old or older.I can follow the study's requirements and stick to the treatment plan.I have a blood clotting disorder or a primary blood disease.I have a bleeding disorder or am taking blood thinners.I've finished certain chemotherapies and recovered from major side effects.I have a weakened immune system or an autoimmune condition.I have signs of an inflammatory or autoimmune condition.
Research Study Groups:
This trial has the following groups:- Group 1: Part II (oncolytic adenovirus Ad5-DNX-2401, surgery)
- Group 2: Part I (oncolytic adenovirus Ad5-DNX-2401)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA given sign-off to Therapeutic Conventional Surgery?
"The safety of Therapeutic Conventional Surgery is estimated to be a 1 given the limited evidence currently available. This is supported by its Phase 1 trial status, which suggests few studies have been conducted on efficacy and safety."
Answered by AI
Are there any spots open to join this research endeavor?
"Affirmative. According to the information found on clinicaltrials.gov, this medical study is actively recruiting participants since its posting date on February 12th 2019 and latest update on August 11th 2022. This clinical trial seeks 36 patients from one location specifically."
Answered by AI
How many individuals can enrol in this clinical experiment?
"Affirmative. As reported on clinicaltrials.gov, this medical trial is presently recruiting participants and was first posted on February 12th 2019 with the most recent edit being made on August 11th 2022. The research team needs to enroll 36 patients from one centre."
Answered by AI
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