HSV-tk and XRT and Chemotherapy for Newly Diagnosed GBM
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03603405|
Recruitment Status : Recruiting
First Posted : July 27, 2018
Last Update Posted : August 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Anaplastic Astrocytoma||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 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 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 Newly Diagnosed Anaplastic Astrocytoma and Glioblastoma Multiforme.|
|Actual Study Start Date :||February 28, 2018|
|Estimated Primary Completion Date :||December 31, 2023|
|Estimated Study Completion Date :||December 31, 2025|
Experimental: Experimental: 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.
Drug: ADV/HSV-tk (gene therapy)
The investigational adenovirus gene therapy injected at tumor site followed by valacyclovir, radiotherapy, and chemotherapy
- 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.
- 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 ]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): NCT03603405
|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|