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Glioma HSV-1 - Healing Genes
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Glioma HSV-1

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Genetically Engineered HSV-1 Phase 1 Study for the Treatment of Recurrent Malignant Glioma (M032-HSV-1)

A Phase 1 Study of M032 (NSC 733972), a Genetically Engineered HSV-1 Expressing IL-12, in Patients With Recurrent/Progressive Glioblastoma Multiforme, Anaplastic Astrocytoma, or Gliosarcoma


Phase 1

DESCRIPTION:

The University of Alabama at Birmingham is conducting a trial of an experimental treatment for

  • Recurrent Glioblastoma Multiforme
  • Progressive Glioblastoma Multiforme
  • Anaplastic Astrocytoma or Gliosarcoma

The investigatory drug uses a virus to deliver a cancer suicide gene called HSV-tK to their tumor. The virus is oncolytic, meaning it can replicate in and kill cancer cells, but it cannot replicate in normal cells. It causes cancer cells, before their death, to produce anti-tumor interleukin 12 (IL-12) which recruits the immune system’s anti-tumor response and also slows the growth of blood vessels that could feed the tumor.

The investigational treatment will be delivered as a single dose of the therapy infused through catheters into portions of tumor defined by MRI, with follow up for 12 months.


PATIENT MUST:

  • Be 19 years of age or older
  • Have a diagnosis of an eligible cancer that has not responded to standard therapy
  • Have a life expectancy ≥ 4 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. MRI-guided injections of the investigatory drug into the tumor(s).
  3. Follow up from post-injection through a 12 month period.

LOCATIONS AND CONTACTS:
The study site is at the University of Alabama at Birmingham. Map.
 
Contacts:
Kristen O. Riley, MD  |  205-996-2461  |  [email protected]
Burt Nabors, MD  |  205-934-1813  |  [email protected]
 
SPONSOR INFORMATION:
University of Alabama at Birmingham
 
Or go online:
https://clinicaltrials.gov/ct2/show/NCT02062827

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