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Virus Therapy
Gene Therapy + Chemoradiotherapy for Glioblastoma
Phase 1 & 2
Recruiting
Led By David S Baskin, MD
Research Sponsored by David Baskin MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have biopsy proven recurrent anaplastic astrocytoma or glioblastoma multiforme without evidence of multifocal tumor or brainstem involvement
Patients should have the following characteristics: recurrent glioblastoma or AA demonstrated by biopsy or imaging study, ECOG performance status of 0-1, has had prior surgery and radiotherapy/chemotherapy for the glioblastoma
Must not have
Presence of active or suspected acute or chronic uncontrolled infection or history of immunocompromise, including a positive HIV test result
Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications (Valacyclovir)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 60 months as measured in months
Awards & highlights
No Placebo-Only Group
Summary
This trial is studying if a combination of HSV-tk gene therapy, valacyclovir, radiotherapy, and temozolomide is effective in treating patients with glioblastoma multiforme that has come back.
Who is the study for?
This trial is for adults with recurrent anaplastic astrocytoma or glioblastoma multiforme, confirmed by biopsy. Participants must have a life expectancy of at least 12 weeks, be recovered from previous treatments, and not have multifocal disease or brainstem involvement. They should use effective birth control and agree to provide biopsies. Those with other active cancers (except certain skin cancers), pregnant or breastfeeding women, and individuals unable to take oral medications are excluded.
What is being tested?
The study tests the combination of HSV-tk gene therapy with valacyclovir medication, stereotactic body radiotherapy (SBRT), and chemotherapy in patients who have had their glioblastoma return. It aims to evaluate the safety and effectiveness of this approach.
What are the potential side effects?
Potential side effects may include reactions related to gene therapy such as flu-like symptoms, issues from valacyclovir like headache or nausea, complications from radiotherapy including fatigue or skin irritation, and typical chemotherapy side effects like hair loss, nausea/vomiting, low blood counts leading to increased infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a confirmed diagnosis of recurrent anaplastic astrocytoma or glioblastoma without multiple tumor locations or brainstem involvement.
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I have recurrent glioblastoma, can mostly care for myself, and had surgery and treatment before.
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I am not pregnant or breastfeeding and have a recent negative pregnancy test.
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I am using effective birth control methods.
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My recent blood tests show my organs are functioning well.
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I have no active cancer except for skin cancer.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have an active infection or a compromised immune system.
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I cannot swallow pills due to a condition in my upper GI tract.
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I am under 18 years old.
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I have an active brain infection shown on brain scans.
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My cancer has spread to multiple areas including the brainstem.
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I am taking immunosuppressive drugs, not including steroids for brain swelling.
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My cancer has not spread widely in my brain or spine.
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I have liver disease, like cirrhosis or hepatitis B/C.
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I am not allergic to the medications used in this study.
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I haven't had immunotherapy or gene therapy in the last 3 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 60 months as measured in months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 60 months as measured in months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Survival in months from Study drug administration (Day 0)
Secondary study objectives
Progression Free Survival assessments will be done every 6-8 weeks for 1st year thereafter every 12-14 weeks until disease progression or death
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: ADV/HSV-tk (gene therapy)Experimental Treatment1 Intervention
The gene therapy investigational product, HSV-tk will be injected during the surgery. Within 24 hours valacyclovir will be given for 14 days. Radiotherapy will be administered over 10 sessions (over 2 weeks) starting within 9 days of surgery. Standard of care/routine chemotherapy will be started concurrent or after completion of the radiotherapy dependent on patient status based on best clinical judgment.
Patient can receive second treatment of HSV-tk after 6 months
Find a Location
Who is running the clinical trial?
Center for Cell and Gene Therapy, Baylor College of MedicineOTHER
112 Previous Clinical Trials
2,793 Total Patients Enrolled
2 Trials studying Glioblastoma
18 Patients Enrolled for Glioblastoma
David Baskin MDLead Sponsor
David S Baskin, MDPrincipal InvestigatorHouston Methodist Neurological Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had chemotherapy, radiation, immunotherapy, or experimental drugs for my brain tumor in the last 3 weeks.I have no active cancer except for certain skin cancers or treated cancers that have been clear for over 5 years.I have a confirmed diagnosis of recurrent anaplastic astrocytoma or glioblastoma without multiple tumor locations or brainstem involvement.I may have cancer cells in the fluid around my brain and spinal cord.I have signed and understand the consent form for this study.I do not have an active infection or a compromised immune system.I cannot swallow pills due to a condition in my upper GI tract.I am under 18 years old.I have an active brain infection shown on brain scans.I do not have any active, untreated skin infections or wounds.I can get a second HSV-tk treatment after 6 months.I have recurrent glioblastoma, can mostly care for myself, and had surgery and treatment before.I am not pregnant or breastfeeding and have a recent negative pregnancy test.I am using effective birth control methods.My recent blood tests show my organs are functioning well.My cancer has spread to multiple areas including the brainstem.I am taking immunosuppressive drugs, not including steroids for brain swelling.My cancer has not spread widely in my brain or spine.I do not have large leptomeningeal metastases that could block the flow of brain fluid.I have liver disease, like cirrhosis or hepatitis B/C.It's been over 3 weeks since my last major surgery, radiation, or cancer treatment.I am willing to undergo biopsies for the study.I have no active cancer except for skin cancer.I am not allergic to the medications used in this study.I haven't had immunotherapy or gene therapy in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: ADV/HSV-tk (gene therapy)
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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