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

  • End date
    Dec 30, 2025
  • participants needed
  • sponsor
    David Baskin MD
Updated on 6 September 2023
platelet count
glioblastoma multiforme
recurrent glioblastoma
anaplastic astrocytoma
astrocytoma, anaplastic


Study to assess the safety and efficacy of HSV-tk (gene therapy), valacyclovir, radiotherapy and chemotherapy in recurrent glioblastoma multiforme.


This is a prospective phase I-II study to assess the efficacy and toxicity of HSV-tk + valacyclovir gene therapy in combination with radiotherapy in recurrent glioblastoma multiforme or anaplastic astrocytoma. This study is comprised of patients who have failed standard of care treatment (maximal safe resection followed by chemoradiation).

Clinical response will be evaluated by neurological evaluation, neuropsychological testing, and imaging studies as well as by histological examination wherever a re-operation is clinically indicated. Blood samples will be taken for systemic immunological response, blood counts and liver functions tests. Toxicity will be graded by the Common Terminology Criteria for Adverse Events (CTCAE) and Radiation Therapy Oncology Group (RTOG) neuro-toxicity scores. Patients will also be followed to assess median time to progression and median survival.

Condition Glioblastoma Multiforme, Astrocytoma, Grade III
Treatment ADV/HSV-tk (gene therapy)
Clinical Study IdentifierNCT03596086
SponsorDavid Baskin MD
Last Modified on6 September 2023


Yes No Not Sure

Inclusion Criteria

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
No evidence of other active malignancy (except squamous or basal cell skin cancers)
Patients with leptomeningeal disease may be considered for enrollment into the study
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 Criteria

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
Patients on immunosuppressive drugs (other than steroids for brain edema)
Evidence of multifocal disease, brainstem involvement
Liver disease, such as cirrhosis or active/chronic hepatitis B or C
History of or current alcohol misuse/abuse within the past 12 months
In patients with leptomeningeal disease, no evidence of diffuse disease or spread to the spine
Known or suspected allergy or hypersensitivity to any component of the proposed regimen (gene vector-HSV-tk, Valacyclovir)
In patients with leptomeningeal disease, no bulky leptomeningeal metastases with potential to obstruct CSF flow will not be enrolled
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
The presence of active untreated cellulitis or untreated wound infections. Treated and resolving cellulitis and infections are not an exclusion criteria
Active IV drug abuse or severe opioid abuse
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note