HSV-tk and XRT and Chemotherapy for Newly Diagnosed GBM
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Methodist Hospital Research Institute
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
ADV/HSV-tk (gene therapy)
DrugThe investigational adenovirus gene therapy injected at tumor site followed by valacyclovir, radiotherapy, and chemotherapy
Treatment groups
62 Participants
are divided into 1 treatment groupGroup A: Experimental: ADV/HSV-tk (gene therapy)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to 60 months measured in monthsSecondary 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.
Time frame
Up to 60 months measured in monthsSponsors and contacts
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Source ClinicalTrials.gov