Is NCT07076498 recruiting in Houston, TX?

Yes, NCT07076498 is currently recruiting participants at its Houston, TX location. This glioma clinical trial is actively enrolling qualified participants.

How do I join the glioma clinical trial in Houston?

To join this clinical trial in Houston, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Houston clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Glioma Clinical Trial in Houston, TX

Who Can Participate

Inclusion Criteria

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 50% of the axial diameter of the pons)

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 8 weeks of radiation therapy completion.

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 Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable

Exclusion Criteria

ary factor which may be one of the following:

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, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.

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 Exclusion Criteria:

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 unknown potential risk of adverse effects on both the mother and nursing infants associated with treatment using M032

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 steroids will not be excluded from the study.

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 of corticosteroids

Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy 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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Houston?

Yes, this clinical trial (NCT07076498) has an active research site in Houston, TX that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Glioma Treatment Options in Houston, TX

If you're searching for glioma treatment options in Houston, TX, this clinical trial (NCT07076498) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Houston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced glioma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all glioma clinical trials near you to find additional studies recruiting in your area.

Glioma Clinical Trial in Houston, TX

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