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Virus Therapy
Gene Therapy + Radiotherapy for Brain Tumor
Phase 1
Recruiting
Led By Tobias Walbert, MD, PhD
Research Sponsored by Henry Ford Health System
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 pre-surgery (day 0), 3, 7, 14, 21, 30, 90 days.
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a therapy combo for recurrent brain tumors to find the best dose to use.
Who is the study for?
Adults with recurrent high-grade astrocytoma eligible for tumor resection, not previously treated with certain gene/immunotherapies or implants. Must have good organ function, no immune disorders, and agree to birth control. Excludes those with serious illnesses that could interfere with the trial, pregnant/lactating women, allergy to protocol products, impaired immunity, inability to undergo MRI, acute infections or liver disease.
What is being tested?
The study tests a maximum tolerated dose of Ad5-yCD/mutTKSR39rep-ADP adenovirus combined with fractionated stereotactic radiosurgery in patients undergoing surgery for recurrent high-grade astrocytoma. It's a Phase I trial focused on safety and dosage levels.
What are the potential side effects?
Potential side effects may include typical reactions related to gene therapy such as flu-like symptoms (fever, fatigue), injection site pain/swelling/redness; complications from radiosurgery like headaches or nausea; and risks associated with brain surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-surgery (day 0), 3, 7, 14, 21, 30, 90 days.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-surgery (day 0), 3, 7, 14, 21, 30, 90 days.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Maximum Tolerated Dose
Secondary study objectives
1. Assessment of antitumor immune response
2. Assessment of change in antitumor immune response by peripheral blood monoclonal cell (PBMC) counts
Assessment of antitumor immune response by using antibodies against surface markers
Other study objectives
Quality of life as assessed using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-BN20
Quality of life as assessed using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Ad5-yCD/mutTKSR39rep-ADP adenovirus and fSRS ArmExperimental Treatment1 Intervention
Subjects will receive a single intratumoral injection of the Ad5-yCD/mutTKSR39rep-ADP adenovirus at one of three dose levels beginning at 1 x 1011 vp and escalating in half-log (3-fold) increments to 1 x 1012 vp, along with the same dose of fractionated stereotactic radiosurgery until unacceptable toxicity, disease progression, or withdrawal of consent.
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Who is running the clinical trial?
Henry Ford Health SystemLead Sponsor
311 Previous Clinical Trials
2,176,348 Total Patients Enrolled
1 Trials studying Astrocytoma
55 Patients Enrolled for Astrocytoma
Tobias Walbert, MD, PhDPrincipal InvestigatorHenry Ford Health System
1 Previous Clinical Trials
55 Total Patients Enrolled
1 Trials studying Astrocytoma
55 Patients Enrolled for Astrocytoma
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I can care for myself but may need occasional help.My immune system is weak and I easily get serious viral infections.I am not on immunosuppressive therapy, except for corticosteroids.It has been over 4 weeks since my last non-nitrosourea chemotherapy.My recurrent tumor can be partially or completely surgically removed.It has been over 6 weeks since I finished chemotherapy that included nitrosourea.My brain tumor has shown signs of growing or returning on scans.I am not a candidate for surgery to remove my cancer.I do not have an immune disorder or take immunosuppressive drugs.I currently have an infection.My brain tumor is confirmed and suspected to have grown before surgery.It has been over 3 months since my last radiation treatment.I don't have any health or mental conditions that would stop me from safely participating in the trial.I have had liver disease, such as autoimmune or viral hepatitis.I have recovered from major side effects of my previous treatment.I will use barrier protection during and for 3 months after my virus treatment.I haven't had gene, virus, immunotherapy, or certain other treatments for my tumor.My organ functions are normal.I am considered a candidate for surgery to remove tumor regrowth, as agreed by a team of cancer specialists.I will use birth control during and for 3 months after my treatment.My brain surgery won’t open into the brain’s fluid spaces.My kidneys work well enough (creatinine clearance ≥ 50 mL/min).I am 18 or older, can give consent, and agree to follow the study rules.
Research Study Groups:
This trial has the following groups:- Group 1: Ad5-yCD/mutTKSR39rep-ADP adenovirus and fSRS Arm
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.
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