HSV-tk and XRT and Chemotherapy for Newly Diagnosed GBM (NCT03603405) | Clinical Trial Compass
RecruitingPhase 1/2
HSV-tk and XRT and Chemotherapy for Newly Diagnosed GBM
United States62 participantsStarted 2018-02-28
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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.
* 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 contro…
What they're measuring
1
Overall Survival in months up to 5 years from Study drug administration (Day 0)