Glioblastoma MultiformePhase 1/2NCT03596086
HSV-tk + Valacyclovir + SBRT + Chemotherapy for Recurrent GBM
A Phase 1/2 study testing ADV/HSV-tk (gene therapy) in people with Glioblastoma Multiforme and Astrocytoma, Grade III, run by David Baskin MD at 1 site in United States.
Trial summary
Study to assess the safety and efficacy of HSV-tk (gene therapy), valacyclovir, radiotherapy and chemotherapy in recurrent glioblastoma multiforme. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma Multiforme, Astrocytoma, Grade III
- What is being tested?
- ADV/HSV-tk (gene therapy)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Dec 2017to 30 Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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.
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Houston Methodist Neurological Institute
Houston, Texas, 77030
David S Baskin, MD, 713-441-3800, DBaskin@houstonmethodist.org
Helga M Jones, 713-363-9388, HMJones@houstonmethodist.org
About this study
Official title: Phase I-II Study Evaluating HSV-tk + Valacyclovir Gene Therapy Combination With Radiotherapy and Chemotherapy for Recurrent Glioblastoma Multiforme
Study to assess the safety and efficacy of HSV-tk (gene therapy), valacyclovir, radiotherapy and chemotherapy in recurrent glioblastoma multiforme.
Read the detailed description
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.
- Conditions
- Glioblastoma Multiforme, Astrocytoma, Grade III
- Being tested
- ADV/HSV-tk (gene therapy)
- Keywords
- GBM, glioblastoma, Astrocytoma
- Medical subject headings
- Glioblastoma, Astrocytoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADV/HSV-tk (gene therapy)Drug
Also called gene transfer, gene therapy, HSV-tk
The investigational adenovirus gene therapy injected at tumor site followed by valacyclovir, radiotherapy, and chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| ADV/HSV-tk (gene therapy) | Experimental | 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 Receives: Drug: ADV/HSV-tk (gene therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival in months from Study drug administration (Day 0)
The overall survival in months of recurrent GBM patients drug administration up to five years
Measured: Up to 60 months as measured in months.
Secondary outcomes (1)
Progression Free Survival assessments will be done every 6-8 weeks for 1st year thereafter every 12-14 weeks until disease progression or death
Patients will have MRI or CT every 6-8 weeks for the first year post surgery. Thereafter patient will have MRI or CT every 12-14 weeks until completion of the protocol study specific treatment. Progression free survival will be assessed by RANO response criteria.
Measured: Up to 60 months as measured in months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start11 Dec 2017
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- David Baskin MD
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Cell and Gene Therapy, Baylor College of Medicine, The Methodist Hospital Research Institute
- Responsible party
- Sponsor-investigator, David Baskin MD, The Methodist Hospital Research Institute
- Investigators
- David S Baskin, MD, Principal investigator, Houston Methodist Neurological Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03596086
- Sponsor's protocol ID
- Pro00016414
- Status last verified
- Mar 2026
- First submitted
- 20 Mar 2018
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: To be determined
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I-II Study Evaluating HSV-tk + Valacyclovir Gene Therapy Combination With Radiotherapy and Chemotherapy for Recurrent Glioblastoma Multiforme
- ClinicalTrials.gov ID
- NCT03596086
- Acronym / sponsor ID
- Pro00016414
- Conditions
- Glioblastoma Multiforme, Astrocytoma, Grade III
- Keywords
- GBM, glioblastoma, Astrocytoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- David Baskin MDUniversity, hospital or other
- Collaborators
- Center for Cell and Gene Therapy, Baylor College of Medicine, The Methodist Hospital Research Institute
- Study start
- 11 Dec 2017 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 23 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to assess the safety and efficacy of HSV-tk (gene therapy), valacyclovir, radiotherapy and chemotherapy in recurrent glioblastoma multiforme.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADV/HSV-tk (gene therapy) | Experimental | Drug: ADV/HSV-tk (gene therapy)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADV/HSV-tk (gene therapy)Also: gene transfer, gene therapy, HSV-tkThe investigational adenovirus gene therapy injected at tumor site followed by valacyclovir, radiotherapy, and chemotherapy | Drug | ADV/HSV-tk (gene therapy) |
Primary outcome
Survival in months from Study drug administration (Day 0)
Time frame: Up to 60 months as measured in months.
The overall survival in months of recurrent GBM patients drug administration up to five years
1 secondary outcome
Progression Free Survival assessments will be done every 6-8 weeks for 1st year thereafter every 12-14 weeks until disease progression or death
Time frame: Up to 60 months as measured in months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: Undecided. To be determined
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David S Baskin, MD principal investigator
Houston Methodist Neurological Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ADV/HSV-tk (gene therapy) in people with Glioblastoma Multiforme and Astrocytoma, Grade III, run by David Baskin MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David S Baskin, MD (713-441-3803 or 713-201-5792, DBaskin@houstonmethodist.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival in months from Study drug administration (Day 0) (time frame: Up to 60 months as measured in months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.