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Virus Therapy

Genetically Engineered HSV-1 for Brain Cancer (M032-HSV-1 Trial)

Phase 1

Waitlist Available

Led By James M. Markert, MD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have histologically or cytologically confirmed glioblastoma multiforme, anaplastic astrocytoma, or gliosarcoma

Patients must have failed external beam radiotherapy to the brain, and if eligible and tolerated, undergone appropriate treatment with temozolomide chemotherapy. All radiation and additional chemotherapies must have been completed at least 4 weeks prior to enrollment. Prior therapy with nitrosoureas must have been completed at least 6 weeks prior to enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to12 months

Awards & highlights

M032-HSV-1 Trial Summary

This trial is testing a potential treatment for brain cancer that uses a laboratory-engineered virus. The goal is to see if it is safe and tolerable for patients who are not eligible for surgery.

Who is the study for?

Adults over 18 with certain types of brain tumors (glioblastoma, astrocytoma, gliosarcoma) that have recurred. They must have tried radiotherapy and chemotherapy already, be in good health otherwise, not pregnant or breastfeeding, willing to use contraception and avoid contact with vulnerable individuals post-treatment. Tumors should be a specific size and location for local treatment.Check my eligibility

What is being tested?

The trial is testing M032 (NSC 733972), a genetically engineered Herpes Simplex Virus-1 designed to treat recurrent malignant gliomas. It's given directly into the tumor site to see if it's safe at its highest dose and how well patients tolerate it.See study design

What are the potential side effects?

While specific side effects are not listed here, similar treatments can cause flu-like symptoms, headache, fatigue, injection site reactions. There may also be risks associated with herpes virus infection since M032 is based on HSV-1.

M032-HSV-1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My diagnosis is glioblastoma, anaplastic astrocytoma, or gliosarcoma.

Select...

I've had brain radiation and temozolomide chemotherapy, but they didn't work, and it's been over 4 weeks since my last treatment.

Select...

My blood tests show normal organ function and healthy blood cell counts.

Select...

My tumor is between 1.0 cm and 5.5 cm and hasn't spread across the brain's midline.

Select...

I am able to care for myself and perform normal activities.

M032-HSV-1 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum Tolerated Dose (MTD) of M032

Secondary outcome measures

The Time of Biologic Assessment

The Time of Survival Assessment

Time to Progression Assessment

M032-HSV-1 Trial Design

1Treatment groups

Experimental Treatment

Group I: Group A single dose of HSV-1 (M032)Experimental Treatment1 Intervention

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

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,124 Total Patients Enrolled

University of Alabama at BirminghamLead Sponsor

1,581 Previous Clinical Trials

2,278,000 Total Patients Enrolled

James M. Markert, MDPrincipal InvestigatorUniversity of Alabama at Birmingham

Media Library

M032 (NSC 733972) (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02062827 — Phase 1

Brain Tumor Research Study Groups: Group A single dose of HSV-1 (M032)

Brain Tumor Clinical Trial 2023: M032 (NSC 733972) Highlights & Side Effects. Trial Name: NCT02062827 — Phase 1

M032 (NSC 733972) (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02062827 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA officially sanctioned M032 (NSC 733972) for use?

"In light of the limited clinical evidence regarding M032's (NSC 733972) efficacy and safety, we have assigned it a score of 1."

Answered by AI

Is enrollment into this trial actively being sought out?

"Contrary to what is seen on clinicaltrials.gov, this particular medical trial is not presently seeking participants; while it had been posted in November 2013 and updated last September 14th 2022, there are currently 1,411 other studies that have recruitment ongoing."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

James Markert, MD 2013. "Genetically Engineered HSV-1 Phase 1 Study for the Treatment of Recurrent Malignant Glioma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02062827.

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