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New treatment option for Glioma
Official title Engineered HSV-1 M032 for the Treatment of Children and Adults With Newly Diagnosed Diffuse Midline Glioma After Standard of Care Radiation
ClinicalTrials.gov ID: NCT07076498
What this study is testing
What is M032?
M032 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for glioma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical research study is to learn about the safety and effects of M032 given directly into the tumor in children and adults with DMG and who have received standard-of-care radiation therapy.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 36 and older
You may be able to join if
- Age ≥ 36 months
- Newly diagnosed pathologically proven diffuse midline glioma (DMG) (H3 K27M mutant) or radiographic and/or pathologically proven pontine DMG (tumors...
- Patient must have received standard of care radiation ≥ 4 but ≤ 8 weeks prior to study enrollment Note: The eligibility determination, enrollment...
- The tumor characteristics for enrollment are as follows:
- The lesion must be ≥ 1.0 cm and ≤ 4.0 cm in diameter and surgically accessible as determined by MRI
You likely can't join if
- Patients who previously received other investigational agents
- Patients with untreated symptomatic hydrocephalus
- Patients with a radiographic atypical pontine DMG or exophytic glioma, unless biopsy confirmed H3K27M alteration
- Patients with a primary spinal cord tumor
- Acute infection, granulocytopenia, or medical condition precluding surgery
- Pregnant or lactating females: Pregnant women are excluded from this study due to the unknown potential of M032 to cause teratogenic or abortifacient...
See the full eligibility criteria
Who can join
- Age ≥ 36 months
- Newly diagnosed pathologically proven diffuse midline glioma (DMG) (H3 K27M mutant) or radiographic and/or pathologically proven pontine DMG (tumors with an epicenter in the pontine and diffuse involvement in at least...
- Patient must have received standard of care radiation ≥ 4 but ≤ 8 weeks prior to study enrollment Note: The eligibility determination, enrollment, pre-surgical planning, and M032 administration must be completed within...
- The tumor characteristics for enrollment are as follows:
- The lesion must be ≥ 1.0 cm and ≤ 4.0 cm in diameter and surgically accessible as determined by MRI
- For patients diagnosed with supratentorial DMG, tumors larger than 4.0 cm may be eligible if they can be surgically debulked to ≤ 4.0 cm
- Patients must have fully recovered from acute treatment-related toxicities prior to entering this study. The study entry timepoint is defined as the time of consent
- Previous treatment guidelines (if applicable):
- Monoclonal antibody (i.e., bevacizumab): patient must have received last dose ≥ 21 days prior
- Radiation: Patients must have received their last fraction of radiation ≥ 4 weeks and ≤ 8 weeks prior to study entry
- Temozolomide: Patients must have received their last dose of chemotherapy ≥ 4 weeks prior Normal hematological, renal, and liver function as defined below:
- Hemoglobin \> 9g/dL
- White blood cell ≥ 3,000/μL
- Absolute neutrophil count ≥ 1000/mm3
- Platelets ≥ 100,000/mm3
- PT or PTT ≤ 1.3 x control
- Creatinine within normal institutional limits OR creatinine clearance ≥ 60 mL/min/1.73 m2 (cystatin C preferred) for patients with creatinine levels above institutional normal
- Total Bilirubin ≤ 1.5 mg/dl
- Transaminases \< 3 times above the upper limits of the institutional norm
- Patients \< 16 years, Modified Lansky score ≥ 60; patients ≥ 16 years, Karnofsky score ≥ 60
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to...
- Postmenopausal (no menses in greater than or equal to 12 consecutive months).
- History of hysterectomy or bilateral salpingo-oophorectomy.
- Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
- History of bilateral tubal ligation or another surgical sterilization procedure.
- Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy...
- Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of study agent administration.
- Written informed consent in accordance with institutional and FDA guidelines must be obtained from the patient or legal guardian
What rules you out
- Patients who previously received other investigational agents
- Patients with untreated symptomatic hydrocephalus
- Patients with a radiographic atypical pontine DMG or exophytic glioma, unless biopsy confirmed H3K27M alteration
- Patients with a primary spinal cord tumor
- Acute infection, granulocytopenia, or medical condition precluding surgery
- Pregnant or lactating females: Pregnant women are excluded from this study due to the unknown potential of M032 to cause teratogenic or abortifacient effects. Lactating females are excluded from this study due to the...
- Diagnosis of encephalitis or CNS infection \< 12 weeks prior
- Receiving ongoing treatment for encephalitis, CNS infection, or multiple sclerosis
- Tumor involvement which would require ventricular inoculation or would require access through a ventricle to deliver treatment
- Patients may not be on immunosuppressive therapy (for at least 1 week), including corticosteroids at the time of enrollment. Physiological replacement of corticosteroids, intermittent use of bronchodilators, or topical...
- Known HIV seropositivity or known immune deficiency
- Patient with an active herpes infection with clinical symptomology
- Concurrent therapy with any drug active against HSV (acyclovir, valacyclovir, penciclovir, famciclovir, ganciclovir, foscarnet, cidofovir) or any systemic immunosuppressive drug therapy (except physiological replacement...
- Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or how well it works assessment of the investigational regimen for this trial.
- Concurrent anticancer or investigational drug
- Patients with medical contraindications for MRI or MRI contrast agents.
- Patients who have received a live vaccine within 30 days prior to planned M032 treatment.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 36 months and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.