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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 below

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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:

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 months as measured in months for reporting.

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

0 / 16Eligibility criteria met