HSV-tk + Valacyclovir + SBRT + Chemotherapy for Recurrent GBM

This study is testing a new treatment approach for recurrent glioblastoma multiforme (a type of aggressive brain tumor) or anaplastic astrocytoma (another type of brain tumor). It combines an investigational gene therapy called ADV/HSV-tk, which is injected directly into the tumor, with valacyclovir (an antiviral medication), radiation therapy (SBRT), and chemotherapy. This treatment is for patients whose cancer has returned after standard treatments. The main goal is to see how long patients live after receiving the study treatment. Researchers will also look at how safe the treatment is and how well it works by checking your neurological health, thinking abilities, and imaging scans. You can join if you are 18 or older and have biopsy-proven recurrent anaplastic astrocytoma or glioblastoma multiforme without certain widespread disease.

Study design: This is a prospective phase I-II study involving 62 participants. It is designed to assess the efficacy and toxicity of the combined treatment.
What's involved: You would receive the ADV/HSV-tk gene therapy, followed by valacyclovir, radiotherapy, and chemotherapy. You will have neurological evaluations, neuropsychological testing, imaging studies, and blood tests. If a re-operation is needed, tissue will be examined.
Compensation: Not stated in the trial record.
Follow-up: You will be followed for up to 60 months (5 years) after receiving the study drug to measure survival.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

HSV-tk + Valacyclovir + SBRT + Chemotherapy for Recurrent GBM

Recruiting

PHASE1Ages 18+InterventionalTreatment

David Baskin MD

~62 participants

Updated 2026-03-30 on ClinicalTrials.gov

What's tested:ADV/HSV-tk (gene therapy)

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Survival in months from Study drug administration (Day 0)

Measured over Up to 60 months as measured in months.

Conditions

Glioblastoma Multiforme

Astrocytoma, Grade III

Where it's being run

1 sites across 1 states

Texas1

Study leadership

David S Baskin, MD · PRINCIPAL_INVESTIGATOR · Houston Methodist Neurological Institute

Who to contact

David S Baskin, MD

[email protected]

713-441-3803 or 713-201-5792

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

All patients must have biopsy proven recurrent anaplastic astrocytoma or glioblastoma multiforme without evidence of multifocal tumor or brainstem involvement. Multifocal disease does not exist if enhancing areas are connected by abnormal T2 FLAIR on the MRI scan.

Radiographic evidence of recurrence/progression by iRANO criteria

≥ 3 weeks since any major surgery, completion of RT, or completion of all prior systemic anticancer therapy (adequately recovered from the acute toxicities of any prior therapy).

Life expectancy ≥ 12 weeks.

Patient can receive second treatment of HSV-tk after 6 months

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.

Patients with leptomeningeal disease may be considered for enrollment into the study.

No evidence of other active malignancy (except squamous or basal cell skin cancers).

Signed informed consent to participate in the study must be obtained from patients after they have been fully informed of the nature and potential risks of the study by the investigator (or his/her designee) with the aid of written information.

Willing to provide biopsies as required by the study.

WOCBP must have a negative serum pregnancy test within 7 days prior to the administration of the first study treatment. Women must not be lactating.

WOCBP and men must practice an effective method of birth control

Patients must have adequate baseline organ function as assessed by the following laboratory values before initiating the protocol:

serum creatinine \< 1.5 mg/dL

T. bilirubin \< 2.5 mg/dL, ALT, AST, GGT and AP \< 2 x normal

Platelet count. \> 100,000/ml , ANC\> 1500/ml , Hgb\> 10 gm/dL

Normal partial thromboplastin time (PTT) and Pro-Thrombin Time (PT)

Non English speaking patients can participate in this study

Exclusion

Prior treatment with immunomodulatory therapy, immunotherapy, and/or gene vector therapy in the past 3 months.

Any cytotoxic chemotherapy, RT, or immunotherapy or any investigational drug for this brain tumor within 3 weeks of study treatment start.

Evidence of multifocal disease, brainstem involvement

Patients on immunosuppressive drugs (other than steroids for brain edema).

In patients with leptomeningeal disease, no evidence of diffuse disease or spread to the spine.

In patients with leptomeningeal disease, no bulky leptomeningeal metastases with potential to obstruct CSF flow will not be enrolled.

Liver disease, such as cirrhosis or active/chronic hepatitis B or C.

History of or current alcohol misuse/abuse within the past 12 months.

Known or suspected allergy or hypersensitivity to any component of the proposed regimen (gene vector-HSV-tk, Valacyclovir).

Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications (Valacyclovir).

No active malignancy except for non-melanoma skin cancer or in situ cervical cancer or treated cancer from which the patient has been continuously disease free for more than 5 years.

Pregnant or breastfeeding women or women/men able to conceive and unwilling to practice an effective method of birth control. WOCBP must have a negative serum pregnancy test within 7 days prior to the administration of the first study treatment.

Presence of active or suspected acute or chronic uncontrolled infection or history of immunocompromise, including a positive HIV test result.

Patients \< 18 years of age

Unwilling or unable to comply with the study protocol.

The presence of active CNS toxoplasmosis infection or Progressive Multifocal Leukoencephalopathy demonstrated on CT or MRI imaging.

Active IV drug abuse or severe opioid abuse

What this trial measures

Survival in months from Study drug administration (Day 0)Up to 60 months as measured in months.
The overall survival in months of recurrent GBM patients drug administration up to five years

Trialytics