GlioblastomaPhase 1/2NCT03603405
HSV-tk and XRT and Chemotherapy for Newly Diagnosed GBM
A Phase 1/2 study testing ADV/HSV-tk (gene therapy) in people with Glioblastoma and Anaplastic Astrocytoma, run by The Methodist Hospital Research Institute 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 newly diagnosed glioblastoma multiforme (GBM) or anaplastic astrocytoma (AA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, Anaplastic Astrocytoma
- 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
- 28 Feb 2018to 31 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 frozen section biopsy proven anaplastic astrocytoma or glioblastoma multiforme without evidence of multifocal disease defined as multiple lesions greater than 2 cm separate from the primary treatment target, or brainstem involvement as well as radiographic evidence consistent with these diagnoses.
- Life expectancy ≥ 12 weeks.
- Patient can receive second treatment of HSV-tk after 6 months
- Patients should have the following characteristics: newly diagnosed anaplastic astrocytoma or glioblastoma demonstrated by frozen section biopsy, prior surgery which demonstrated anaplastic astrocytoma or glioblastoma multiforme which requires repeat surgery for residual tumor, but no radiation or chemotherapy has been received, ECOG performance status of 0-1. 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.
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- 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 Alk Phos < 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)
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 within 3 weeks of study treatment start.
- Evidence of substantial multifocal disease defined as multiple lesions greater than 2cm separate from the primary treatment target, or brainstem involvement. Discrete areas of contrast enhancement connected by abnormal T2 FLAIR signal on MRI scan are not considered multifocal disease, as this represents a single tumor.
- Patients with brainstem involvement, in patients with leptomeningeal disease, no evidence of diffuse disease or spread to the spine.
- 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.
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- 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/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 3 years.
- 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
- 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.
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 Newly Diagnosed Anaplastic Astrocytoma and Glioblastoma Multiforme.
Study to assess the safety and efficacy of HSV-tk (gene therapy), valacyclovir, radiotherapy and chemotherapy in newly diagnosed glioblastoma multiforme (GBM) or anaplastic astrocytoma (AA).
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 and standard of care chemotherapy for anaplastic astrocytoma (AA) or glioblastoma multiforme (GBM). This study is comprised of newly diagnosed patients with AA or GBM.
Clinical response will be evaluated by neurological evaluation, neuropsychological testing, and imaging studies as well as by histological examination. Blood samples will be taken for systemic immunological response, blood counts, and liver functions tests. Genetic testing of tumor tissue will be performed, including genetic analysis and cell cultures. Toxicity will be graded by the Common Terminology Criteria for Adverse Events (CTCAE) v4.03 and Radiation Therapy Oncology Group (RTOG) neuro-toxicity scores (see Appendices). Patients will also be followed to assess median time to progression and median survival.
- Conditions
- Glioblastoma, Anaplastic Astrocytoma
- Being tested
- ADV/HSV-tk (gene therapy)
- Keywords
- GBM, AA, 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 therapy, 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 |
|---|---|---|
| Experimental: ADV/HSV-tk (gene therapy) | Experimental | Experimental: 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 30 sessions (over 6 weeks) starting within 9 days of surgery. Standard of care/routine chemotherapy will be started concurrent with the radiotherapy dependent on patient status based on best clinical judgment following the Stupp protocol.
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.
Overall Survival in months up to 5 years from Study drug administration (Day 0)
The overall survival rate of patients with Anaplastic Astrocytoma and Glioblastoma in months will be assessed up to 5 years from study drug administration.
Measured: Up to 60 months 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 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 posted27 Jul 2018
- Study start28 Feb 2018
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by The Methodist Hospital Research InstituteThe sponsor's other registered studies.
- 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
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal 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
- NCT03603405
- Sponsor's protocol ID
- Pro00018178
- Status last verified
- Mar 2026
- First submitted
- 1 Jul 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 Newly Diagnosed Anaplastic Astrocytoma and Glioblastoma Multiforme.
- ClinicalTrials.gov ID
- NCT03603405
- Acronym / sponsor ID
- Pro00018178
- Conditions
- Glioblastoma, Anaplastic Astrocytoma
- Keywords
- GBM, AA, Glioblastoma, Astrocytoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Study start
- 28 Feb 2018 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 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 newly diagnosed glioblastoma multiforme (GBM) or anaplastic astrocytoma (AA).
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 and standard of care chemotherapy for anaplastic astrocytoma (AA) or glioblastoma multiforme (GBM). This study is comprised of newly diagnosed patients with AA or GBM.
Clinical response will be evaluated by neurological evaluation, neuropsychological testing, and imaging studies as well as by histological examination. Blood samples will be taken for systemic immunological response, blood counts, and liver functions tests. Genetic testing of tumor tissue will be performed, including genetic analysis and cell cultures. Toxicity will be graded by the Common Terminology Criteria for Adverse Events (CTCAE) v4.03 and Radiation Therapy Oncology Group (RTOG) neuro-toxicity scores (see Appendices). 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 |
|---|---|---|
| Experimental: ADV/HSV-tk (gene therapy) | Experimental | Drug: ADV/HSV-tk (gene therapy)Experimental: 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 30 sessions (over 6 weeks) starting within 9 days of surgery. Standard of care/routine chemotherapy will be started concurrent with the radiotherapy dependent on patient status based on best clinical judgment following the Stupp protocol. 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 (14 listed)
- All patients must have frozen section biopsy proven anaplastic astrocytoma or glioblastoma multiforme without evidence of multifocal disease defined as multiple lesions greater than 2 cm separate from the primary treatment target, or brainstem involvement as well as radiographic evidence consistent with these diagnoses.
- Life expectancy ≥ 12 weeks.
- Patients should have the following characteristics: newly diagnosed anaplastic astrocytoma or glioblastoma demonstrated by frozen section biopsy, prior surgery which demonstrated anaplastic astrocytoma or glioblastoma multiforme which requires repeat surgery for residual tumor, but no radiation or chemotherapy has been received, ECOG performance status of 0-1. 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.
Key exclusion criteria (19 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 within 3 weeks of study treatment start.
- Evidence of substantial multifocal disease defined as multiple lesions greater than 2cm separate from the primary treatment target, or brainstem involvement. Discrete areas of contrast enhancement connected by abnormal T2 FLAIR signal on MRI scan are not considered multifocal disease, as this represents a single tumor.
- Patients with brainstem involvement, in patients with leptomeningeal disease, no evidence of diffuse disease or spread to the spine.
- Patients on immunosuppressive drugs (other than steroids for brain edema).
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 therapy, gene therapy, HSV-tkThe investigational adenovirus gene therapy injected at tumor site followed by valacyclovir, radiotherapy, and chemotherapy | Drug | Experimental: ADV/HSV-tk (gene therapy) |
Primary outcome
Overall Survival in months up to 5 years from Study drug administration (Day 0)
Time frame: Up to 60 months measured in months
The overall survival rate of patients with Anaplastic Astrocytoma and Glioblastoma in months will be assessed up to 5 years from study drug administration.
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 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 and Anaplastic Astrocytoma, run by The Methodist Hospital Research Institute 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 14 inclusion and 19 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?
Overall Survival in months up to 5 years from Study drug administration (Day 0) (time frame: Up to 60 months 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.