Genetically Engineered HSV-1 Phase 1 Study for the Treatment of Recurrent Malignant Glioma (NCT02062827) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Genetically Engineered HSV-1 Phase 1 Study for the Treatment of Recurrent Malignant Glioma
United States29 participantsStarted 2013-11-25
Plain-language summary
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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* Patients must have histologically or cytologically confirmed glioblastoma multiforme, anaplastic astrocytoma, or gliosarcoma.
* Prior therapy: 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.
* Age ≥18 years (age of majority for clinical trials in Alabama). Because no dosing or adverse event data are currently available on the use of M032 in patients \<18 years of age, children are excluded from this study but will be eligible for future pediatric phase 1 single-agent trials.
* Karnofsky Performance Status ≥70%
* Life expectancy of greater than 4 weeks.
* Patients must have normal organ and marrow function as defined below:
* Leukocytes: \>3,000/μl
* absolute neutrophil count: \>1,500/μl
* platelets: \>100,000/μl
* total bilirubin within normal institutional limits
* AST(SGOT)(aspartate aminotransferase)/ALT(SGPT)(alanine aminotransferase): \<2.5 X institutional upper limit of normal
* creatinine within normal institutional limits OR
* creatinine clearance: \>60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
* Residual lesion must be ≥1.0 cm and \< 5.5 cm in diameter without bilateral extension thro…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.