Is NCT06389591 recruiting in Gainesville, FL?

Yes, NCT06389591 is currently recruiting participants at its Gainesville, FL location. This recurrent glioblastoma clinical trial is actively enrolling qualified participants.

How do I join the recurrent glioblastoma clinical trial in Gainesville?

To join this clinical trial in Gainesville, 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 Gainesville 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.

Recurrent Glioblastoma Clinical Trial in Gainesville, FL

Who Can Participate

Inclusion Criteria

Age \>/= 18years

Histopathologically proven GBM using the 2021 WHO Classification of Tumors of the CNS (WHO CNS5).

Unequivocal evidence of tumor progression as documented by brain MRI scan per RANO criteria.

Tumor must have a primary supratentorial component at the time of disease progression.

Patients must have received surgery and completed Fractionated Radiation therapy as frontline treatment for primary disease, either alone or with concurrent therapy (including temozolomide or another systemic chemotherapy agent). Patients must be at least 12 weeks post chemoradiation completion.

Patient must be at least 90 days from completion of prior radiation

Any adverse events patient has experienced from prior therapy must have resolved to ≤ Gr. 1 according to CTCAE (NCI Common Terminology Criteria for Adverse Events) v5.0 prior to enrollment

Patient must be either weaned off steroids or weaned onto physiologic dosing at the time of enrollment.

Patient must be a candidate for surgery/biopsy as acceptable standard of care for sterile collection of tumor material in a manner suitable for RNA extraction, amplification, and loading of lipid particles (LPs).

A diagnostic contrast-enhanced MRI of the brain must be performed preoperatively and postoperatively. Pre-op MRI must be performed within 28 days prior to study enrollment.

Performance Score: (KPS) ≥ 60. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.

Bone Marrow:

ANC (Absolute neutrophil count) ≥ 1,500µl (unsupported)

Platelets ≥ 100/µl (unsupported for at least 3 days)

Hemoglobin \> 8 g/dL

BUN ≤ 25 mg/dl

Creatinine ≤ 1.7 mg/dl

Bilirubin ≤ 2.0 mg/dl

ALT ≤ 5 times institutional upper limits of normal for age

AST ≤ 5 times institutional upper limits of normal for age

Patient must be able to give consent.

For women of childbearing potential (WOCBP), negative serum/urine pregnancy test at enrollment.

WOCBP must be willing to use acceptable contraceptive methods to avoid pregnancy throughout the study and for at least 24 weeks after the last dose of study drug.

Males with female partners of childbearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for 24 weeks following the last dose of study drug.

Exclusion Criteria

Patients who received prior treatment with bevacizumab.

Known active infection (requiring treatment by antiviral or antibiotics) or immunosuppressive disease.

Patients with multifocal recurrent disease characterized by more than one enhancing lesion separated by noncontiguous T2/FLAIR signal abnormality. Patients with recurrence outside of the original tumor site are eligible if there is stability at the original site of disease.

Patients with uncontrolled seizure disorders

Any patients that have received any live vaccines within 30 days prior to enrollment

Tumors with primary localization to the brainstem or spinal cord

Severe, active co-morbidity, defined as follows:

Unstable angina and/or congestive heart failure requiring hospitalization.

Unstable cardiac arrhythmias, abnormalities, or transmural myocardial infarction within the last 6 months.

Acute bacterial or fungal infection requiring intravenous treatment at study treatment.

Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at study treatment

Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects.

Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.

Patients with autoimmune disease requiring medical management with immunosuppressants.

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

Pregnancy or women of childbearing potential and men who are sexually active and who are unwilling or unable to use an acceptable method of contraception for the entire study period; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.

Women of childbearing potential must not be pregnant or breast-feeding.

Participants who are receiving any other investigational agents or who have been treated on any other therapeutic clinical protocols within 30 days prior to projected first dose of study treatment.

Participants who are unwilling or unable to receive treatment and undergo follow-up evaluations

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 Gainesville?

Yes, this clinical trial (NCT06389591) has an active research site in Gainesville, FL 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.

Recurrent Glioblastoma Treatment Options in Gainesville, FL

If you're searching for recurrent glioblastoma treatment options in Gainesville, FL, this clinical trial (NCT06389591) 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 Gainesville research site is actively enrolling participants for this clinical trial. You'll receive care from experienced recurrent 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 recurrent glioblastoma clinical trials near you to find additional studies recruiting in your area.

Recurrent Glioblastoma Clinical Trial in Gainesville, FL

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About This Recurrent Glioblastoma Study in Gainesville