Is NCT05734560 recruiting in Durham, NC?

Yes, NCT05734560 is currently recruiting participants at its Durham, NC location. This newly diagnosed mgmt unmethylated glioblastoma clinical trial is actively enrolling qualified participants.

Is participation in this Durham 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.

Newly Diagnosed MGMT Unmethylated Glioblastoma Clinical Trial in Durham, NC

Q: How do I join the newly diagnosed mgmt unmethylated glioblastoma clinical trial in Durham?

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

About This Newly Diagnosed MGMT Unmethylated Glioblastoma Study in Durham

The purpose of this research study is to determine the safety and efficacy of administering a single intracerebral (within the brain) dose of investigational compounds called D2C7-immunotoxin (IT) and 2141-V11 in residual disease (within tumor margins) after surgery, followed by later repeated injections of 2141-V11 in the subcutaneous area (under the skin) around the lymph nodes of the head and neck for adults newly diagnosed with a type of cancerous brain tumor called glioblastoma. The word "investigational" means the study drugs are still being tested in research studies and are not approved by the U.S. Food and Drug Administration (FDA).

Sponsor: Darell Bigner

Who Can Participate

Inclusion Criteria

Age ≥ 18 years of age at the time of entry into the study

Newly diagnosed supratentorial GBM, WHO grade 4, IDH wildtype, MGMT unmethylated (high grade glioma with molecular features of GBM will be eligible under WHO 4 malignant glioma) with residual radiographic non-contrast enhancing disease on the post-2 cycles of adjuvant TMZ MRI amenable to catheter placement. The residual radiographic contrast enhancing disease is ≤ 3 cm in maximal diameter in any plane.

Patient must have completed standard of care radiation therapy (typically 59.4-60 Gy over approximately 6 weeks duration if under 65 years old and a minimum of 40 Gy over 3 weeks duration if 65 years or older) in combination with TMZ and 2 cycles of post-radiation, adjuvant TMZ. For patients known to be MGMT promoter unmethylated prior to start of radiation therapy, patients are not mandated to have received TMZ in combination to radiation therapy prior to participating in this trial.

Karnofsky Performance Score (KPS) \> 70%

Able to undergo brain MRI wiht and without contrast

Hemoglobin ≥ 9 g/dl prior to catheter placement

Platelet count ≥ 100,000/µL unsupported. Because of risks of intracranial hemorrhage with catheter placement, platelet count ≥ 125,000/µl is required for the patient to undergo biopsy and catheter insertion, which can be attained with the help of platelet transfusion

Neutrophil count ≥ 1000 prior to catheter placement

Creatinine ≤ 1.5 x normal range prior to catheter placement

Total bilirubin ≤ 1.5 x upper limit of normal (ULN) prior to catheter placement (Exception: Participant has known or suspected Gilbert's Syndrome for which additional lab testing of direct and/or indirect bilirubin supports this diagnosis. In these instances, a total bilirubin of ≤ 3.0 x ULN is acceptable.)

AST/ALT ≤ 2.5 x ULN

PT and PTT ≤ 1.2 x normal prior to biopsy. Patients with prior history of thrombosis/embolism are allowed to be on anticoagulation, understanding that anticoagulation will be held in the perioperative period per the neurosurgical team's recommendations. Low molecular weight heparin (LMWH) is preferred. If a patient is on warfarin, the international normalized ratio (INR) is to be obtained and value should be below 2.0 prior to biopsy.

Patient or partner(s) meets one of the following criteria:

Non-childbearing potential (i.e. not sexually active, physiologically incapable of becoming pregnant, including any person who is post-menopausal or surgically sterile, or any person who has had a vasectomy). Surgically sterile people are defined as those with a documented hysterectomy and/or bilateral oophorectomy or tubal ligation. Postmenopausal for purposes of this study is defined as 1 year without menses.; or

Childbearing potential and agrees to use one of the following methods of birth control: approved hormonal contraceptives (e.g. birth control pills, patches, implants, or infusions), an intrauterine device, or a barrier method of contraception (e.g. a condom or diaphragm) used with spermicide

A signed ICF approved by the IRB will be required for patient enrollment into the study. Patients must be able to read and understand the informed consent document and must sign the informed consent indicating that they are aware of the investigational nature of this study

Exclusion Criteria

Patients who are pregnant or breast-feeding/chestfeeding

Patients with an impending, life-threatening cerebral herniation syndrome, based on the assessment of the study neurosurgeons or their designate

Patients with severe, active comorbidity, defined as follows:

Patients with an active infection requiring intravenous treatment or having an unexplained febrile illness (Tmax \> 99.5°F/37.5°C)

Patients with known immunosuppressive disease or known human immunodeficiency virus infection

Patients with unstable or severe medical conditions such as severe heart disease (New York Heart Association Class 3 or 4)

Patients with known lung (forced expiratory volume in the first second of expiration (FEV1) \< 50%) disease

Patients with uncontrolled diabetes mellitus

Patients with albumin allergy

Patients with known HIV or Hepatitis C positive status

Major medical illnesses or psychiatric impairments that, in the investigator's opinion, will prevent administration or completion of protocol therapy

Patients who previously received other therapeutic interventions for newly diagnosed GBM with the exception of surgical resection and standard of care concomitant radiation therapy and TMZ and 2 cycles of post-radiation, adjuvant TMZ for their brain tumor

Patients who have received concomitant radiation therapy and TMZ ≤ 11 weeks prior to start of D2C7-IT CED infusion

Patients with evidence of tumor in the brainstem, cerebellum, or spinal cord, radiological evidence of (actively growing) multifocal disease, tumor crossing the midline, extensive subependymal disease, or leptomeningeal disease

Patients on greater than 4 mg per day of dexamethasone within the 2 weeks prior to the start of D2C7-IT infusion

Patients with worsening steroid myopathy (history of gradual progression of bilateral proximal muscle weakness, and atrophy of proximal muscle groups)

Patients with prior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin

Patients with active autoimmune disease requiring systemic immunomodulatory treatment within the past 3 months

Patients who cannot undergo MRI due to obesity or to having certain metal in their bodies (i.e. pacemakers, infusion pumps, metal aneurysm clips, metal prostheses, joints, rods, or plates) or patients with any known severe allergies to contrast agents. Patients with mild allergies (i.e., rash only) are allowed to enroll and will be pretreated with acetaminophen and diphenhydramine prior to injection of the contrast agent.

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 Durham?

Yes, this clinical trial (NCT05734560) has an active research site in Durham, NC 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.

Newly Diagnosed MGMT Unmethylated Glioblastoma Treatment Options in Durham, NC

If you're searching for newly diagnosed mgmt unmethylated glioblastoma treatment options in Durham, NC, this clinical trial (NCT05734560) 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 Durham research site is actively enrolling participants for this phase 1/2 clinical trial. You'll receive care from experienced newly diagnosed mgmt unmethylated glioblastoma 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 newly diagnosed mgmt unmethylated glioblastoma clinical trials near you to find additional studies recruiting in your area.

Newly Diagnosed MGMT Unmethylated Glioblastoma Clinical Trial in Durham, NC

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