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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
Must not have
Chemotherapy, cytotoxic therapy, immunotherapy within 4 weeks prior to study entry (6 weeks for nitrosoureas), surgical resection within 4 weeks prior to study entry, or experimental viral therapy or gene therapy at any time
Prior history of specific CNS conditions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My diagnosis is glioblastoma, anaplastic astrocytoma, or gliosarcoma.
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I've had brain radiation and temozolomide chemotherapy, but they didn't work, and it's been over 4 weeks since my last treatment.
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My blood tests show normal organ function and healthy blood cell counts.
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My tumor is between 1.0 cm and 5.5 cm and hasn't spread across the brain's midline.
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I am able to care for myself and perform normal activities.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't had chemotherapy, immunotherapy, or surgery in the last 4 weeks.
Select...
I have a history of certain brain or nerve conditions.
Select...
My tumor needs specific treatment due to its location or characteristics.
Select...
I am allergic to certain medications similar to M032 or IL-12.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,924 Previous Clinical Trials
41,017,922 Total Patients Enrolled
330 Trials studying Glioblastoma
23,347 Patients Enrolled for Glioblastoma
University of Alabama at BirminghamLead Sponsor
1,646 Previous Clinical Trials
2,342,744 Total Patients Enrolled
10 Trials studying Glioblastoma
228 Patients Enrolled for Glioblastoma
James M. Markert, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had chemotherapy, immunotherapy, or surgery in the last 4 weeks.I have a history of certain brain or nerve conditions.I haven't needed more steroids, don't have an active oral herpes lesion, and am not on drugs for HSV.My tumor needs specific treatment due to its location or characteristics.I am a woman who can have children and I have a negative pregnancy test from the last 14 days.I have been on a stable dose of steroids for at least 2 weeks.I still have side effects from treatments I received over a month ago.I am allergic to certain medications similar to M032 or IL-12.My diagnosis is glioblastoma, anaplastic astrocytoma, or gliosarcoma.I am 18 years old or older.I am able to care for myself and perform normal activities.My blood tests show normal organ function and healthy blood cell counts.My tumor is between 1.0 cm and 5.5 cm and hasn't spread across the brain's midline.I am not pregnant, breastfeeding, HIV positive, allergic to IV contrast, have specific medical devices, or received Gliadel or Avastin therapy recently.I've had brain radiation and temozolomide chemotherapy, but they didn't work, and it's been over 4 weeks since my last treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Group A single dose of HSV-1 (M032)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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