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Newly Diagnosed Glioblastoma Multiforme - Healing Genes
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Newly Diagnosed Glioblastoma Multiforme

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HSV-tk and XRT and Chemotherapy for Newly Diagnosed GBM

Phase I-II Study Evaluating HSV-tK + VALACYCLOVIR GENE THERAPY Combination With Radiotherapy and Chemotherapy for Newly Diagnosed Anaplastic Astrocytoma and Glioblastoma Multiforme


Phase 1 / 2

DESCRIPTION:

Houston Methodist Hospital is conducting a trial of an experimental treatment for newly diagnosed 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.


PATIENT MUST:

  • Be 18 years of age or older
  • Have a diagnosis of glioblastoma multiforme (GBM) or anaplastic astrocytoma (AA) confirmed by biopsy
  • Have a life expectancy ≥ 12 weeks
  • Be willing to use birth control, if sexually active

THE STUDY INVOLVES:

  1. Prescreening tests to confirm eligibility of the patient to participate.
  2. Surgery to inject the viral genetic therapy.
  3. Within 24 hours valacyclovir will be given for 14 days.
  4. Within 9 days of surgery, radiation therapy will begin (30 visits over 6 weeks).
  5. Depending on the treating team’s judgement, the patient may also receive chemotherapy.
  6. 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 site is at the Houston Methodist Neurological Institute. Map.

Contacts:

David S. Baskin, MD  |  713-441-3803 or 713-201-5792  |  [email protected]

Helga M. Jones  |  713-363-9388  |  [email protected]

SPONSOR INFORMATION:

The Methodist Hospital System

Or go online:

https://clinicaltrials.gov/ct2/show/NCT03603405

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