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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
Karnofsky performance status (KPS) ≥ 60 at time of surgery
Patients must be ≥ 18 years of age, able to provide informed consent and express a willingness to meet all the expected requirements of the protocol for the duration of the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-surgery (day 0), 3, 7, 14, 21, 30, 90 days.
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can care for myself but may need occasional help.
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I am 18 or older, can give consent, and agree to follow the study rules.
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My recurrent tumor can be partially or completely surgically removed.
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It has been over 6 weeks since I finished chemotherapy that included nitrosourea.
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My brain tumor has shown signs of growing or returning on scans.
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I do not have an immune disorder or take immunosuppressive drugs.
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My brain tumor is confirmed and suspected to have grown before surgery.
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I have recovered from major side effects of my previous treatment.
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I haven't had gene, virus, immunotherapy, or certain other treatments for my tumor.
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My brain surgery won’t open into the brain’s fluid spaces.
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My organ functions are normal.
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My kidneys work well enough (creatinine clearance ≥ 50 mL/min).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-surgery (day 0), 3, 7, 14, 21, 30, 90 days.
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-surgery (day 0), 3, 7, 14, 21, 30, 90 days. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose
Secondary outcome measures
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 outcome measures
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

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.

Find a Location

Who is running the clinical trial?

Henry Ford Health SystemLead Sponsor
299 Previous Clinical Trials
2,098,729 Total Patients Enrolled
3 Trials studying Glioblastoma
186 Patients Enrolled for Glioblastoma
Tobias Walbert, MD, PhDPrincipal InvestigatorHenry Ford Health System
1 Previous Clinical Trials
55 Total Patients Enrolled
1 Trials studying Glioblastoma
55 Patients Enrolled for Glioblastoma

Media Library

Ad5-yCD/mutTKSR39rep-ADP adenovirus (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05686798 — Phase 1
Glioblastoma Research Study Groups: Ad5-yCD/mutTKSR39rep-ADP adenovirus and fSRS Arm
Glioblastoma Clinical Trial 2023: Ad5-yCD/mutTKSR39rep-ADP adenovirus Highlights & Side Effects. Trial Name: NCT05686798 — Phase 1
Ad5-yCD/mutTKSR39rep-ADP adenovirus (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05686798 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How extensive is the participant pool for this clinical research trial?

"Affirmative. Records on clinicaltrials.gov illustrate that this research is actively enrolling participants; the trial was initially published on November 29th 2022 and updated most recently on January 9th 2023. For now, 18 patients are needed at a single site."

Answered by AI

Are there any opportunities for new enrollees to join this research endeavor?

"Affirmative. According to clinicaltrials.gov, this scientific research has begun recruiting and is open for new participants. The trial was posted on November 29th 2022 with the last update occurring on January 9th 2023. 18 patients are needed at one site for the experiment's completion."

Answered by AI

Has the Ad5-yCD/mutTKSR39rep-ADP adenovirus and fSRS Arm been given official authorization by the FDA?

"Our team at Power has calculated that the safety of Ad5-yCD/mutTKSR39rep-ADP adenovirus and fSRS Arm is a 1 due to this being an early phase trial which does not have much evidence for efficacy or safety."

Answered by AI
~5 spots leftby Oct 2024