HSV-tk + Valacyclovir + SBRT + Chemotherapy for Recurrent GBM
Phase I-II Study Evaluating HSV-tk + Valacyclovir Gene Therapy Combination With Radiotherapy and Chemotherapy for Recurrent Glioblastoma Multiforme
Houston Methodist Hospital is conducting a trial of an experimental treatment for recurrent glioblastoma multiforme (GBM) or anaplastic astrocytoma (AA) that involves using a virus to deliver a cancer suicide gene called HSV-tK to their tumor. In combination with valocyclovir medicine, this gene may cause the cancer to self-detonate by incorporating a molecule that stops their replication. This experimental treatment will be delivered along with standard radiation and chemotherapy.
The investigational treatment will be delivered during a surgery and be followed by radiation and chemotherapy, as determined appropriate by the managing physicians. Follow up with involve MRI or CT every 6 to 8 weeks after surgery, then every 12 to 14 weeks for 5 years.
- Be 18 years of age or older
- Have a diagnosis of glioblastoma multiforme (GBM) or anaplastic astrocytoma (AA) confirmed by biopsy, which has not responded to prior standard treatment
- Have a life expectancy ≥ 12 weeks
- Be willing to use birth control, if sexually active
THE STUDY INVOLVES:
- Prescreening tests to confirm eligibility of the patient to participate.
- Surgery to inject the viral genetic therapy.
- Within 24 hours valacyclovir will be given for 14 days.
- Within 9 days of surgery, radiation therapy will begin (30 visits over 6 weeks).
- Depending on the treating team’s judgement, the patient may also receive chemotherapy.
- Follow up with involve MRI or CT every 6 to 8 weeks after surgery, then every 12 to 14 weeks for 5 years.
LOCATIONS AND CONTACTS:
The study sites are at the Houston Methodist Neurological Institute. Map.
David S. Baskin, MD | 713-441-3803 or 713-201-5792 | [email protected]
Helga M. Jones | 713-363-9388 | [email protected]
David Baskin MD
Center for Cell and Gene Therapy, Baylor College of Medicine
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