HSV-tk + Valacyclovir + SBRT + Chemotherapy for Recurrent GBM
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|ClinicalTrials.gov Identifier: NCT03596086|
Recruitment Status : Recruiting
First Posted : July 23, 2018
Last Update Posted : July 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Multiforme Astrocytoma, Grade III||Drug: ADV/HSV-tk (gene therapy)||Phase 1 Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||62 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I-II Study Evaluating HSV-tk + Valacyclovir Gene Therapy Combination With Radiotherapy and Chemotherapy for Recurrent Glioblastoma Multiforme|
|Actual Study Start Date :||December 11, 2017|
|Estimated Primary Completion Date :||December 30, 2023|
|Estimated Study Completion Date :||December 30, 2025|
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 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.
Drug: ADV/HSV-tk (gene therapy)
The investigational adenovirus gene therapy injected at tumor site followed by valacyclovir, radiotherapy, and chemotherapy
- 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
- 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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03596086
|Contact: David S Baskin, MD||713-441-3803 or 713-201-5792||DBaskin@houstonmethodist.org|
|Contact: Helga M Jones||713-363-9388||HMJones@houstonmethodist.org|
|United States, Texas|
|Houston Methodist Neurological Institute||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: David S Baskin, MD 713-441-3800 DBaskin@houstonmethodist.org|
|Contact: Helga M Jones 713-363-9388 HMJones@houstonmethodist.org|
|Principal Investigator:||David S Baskin, MD||Houston Methodist Neurological Institute|