Symptoms and General Pathology

All Conditions

Neoplasms

Nervous System Diseases

Infections

Rare Diseases

Recurrence

Glioblastoma

Glioma

Brain Neoplasms

Virus Diseases

Astrocytoma

Gliosarcoma

Disease Attributes

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Anaplastic Astrocytoma

Neuroepithelioma

All Drugs and Chemicals

Antineoplastic Agents

Immunomodulating Agents

Interleukin-12

single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI

A single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI

M032 (NSC 733972)

James M. Markert, MD

To determine the safety and tolerability of the maximum dose for laboratory engineered Herpes Simplex Virus-1 in patients who would not be eligible for surgical resection of recurrent glioma To determine the safety and tolerability of the maximum dose for laboratory engineered Herpes Simples Virus-1 in patients who would benefit from surgical resection of recurrent glioma

M032 is a second-generation oncolytic herpes simplex virus (oHSV) that is conditionally replication competent; that is, similar to G207, a first generation oHSV, it can replicate in tumor cells, but not in normal cells, thus killing the tumor cells directly through this process. Replication of M032 in the tumor itself not only kills the infected tumor cells, but causes the tumor cell to act as a factory to produce new virus. These virus particles are released as the tumor cell dies, and can then proceed to infect other tumor cells in the vicinity, and continue the process of tumor kill. In addition to this direct oncolytic activity, the virus carries a therapeutic payload--acting as a gene therapy vector, too--and causes the tumor cell to synthesize and secrete an immunity-stimulating protein called Interleukin-12 (IL-12) before it is killed. This IL-12 is released and promotes an immune response against surviving tumor cells, which increases the antitumor effect of the therapy. The IL-12 that is expressed can also produce an anti-angiogenic effect, by interfering with the production of new tumor blood vessels necessary to allow tumor growth. Anti-angiogenic therapies potentially starve the tumor of necessary oxygen and nutrients. Thus, the M032 oHSV produces three different potential mechanisms for antitumor effects. The virus has also been genetically-engineered to minimize the production of any toxic effects for the patient receiving the therapy.

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

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

National Cancer Institute (NCI)

University of Alabama at Birmingham

Principal Investigator

Participants were administered 10\^5 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI

10^5 Single Dose of HSV-1 (M032)

Participants were administered 10\^6 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI

10^6 Single Dose of HSV-1 (M032)

Participants were administered 10\^7 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI

10^7 Single Dose of HSV-1 (M032)

Participants were administered 10\^7.5 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI

10^7.5 Single Dose of HSV-1 (M032)

Participants were administered 10\^8 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI

10^8 Single Dose of HSV-1 (M032)

Participants were administered 10\^8.5 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI

10^8.5 Single Dose of HSV-1 (M032)

Participants were administered 10\^9 single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI

10^9 Single Dose of HSV-1 (M032)

Participants who consented, but became ineligible prior to receiving M032

Screen Fails

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

James Markert, MD

Participants were administered 10\^5, 10\^6, 10\^7, 10\^7.5, 10\^8, 10\^8.5, or 10\^9 pfu of single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI

Single Dose of HSV-1 (M032)

Maximum Tolerated Dose (MTD) of M032

Time to Progression Assessment

The Time of Survival Assessment

The Time of Biologic Assessment

Participants that consented to the study, but ended up becoming ineligible before they were given M032

Overall Study

Spots Global Cancer Trial Database for anaplastic astrocytoma or gliosarcoma