Is NCT05698524 recruiting in Omaha, NE?

Yes, NCT05698524 is currently recruiting participants at its Omaha, NE location. This recurrent high grade glioma clinical trial is actively enrolling qualified participants.

How do I join the recurrent high grade glioma clinical trial in Omaha?

To join this clinical trial in Omaha, 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 Omaha 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 High Grade Glioma Clinical Trial in Omaha, NE

About This Recurrent High Grade Glioma Study in Omaha

Glioblastoma (GBM), WHO grade IV glioma, represents the majority of adult malignant primary brain tumors, with an incidence of 2-3 per 100,000 person-years. The survival for GBM has increased in the last decade but is still low with a median survival of 15-18 months. Recurrence after initial standard therapy, radiation therapy and chemotherapy with temozolomide, few options are available. Even with further therapy, median progression free survival at 6 months after first relapse (PFS-6) is only 15%. Similarly, anaplastic astrocytoma and anaplastic oligodendroglioma, grade III gliomas, once recurrent after radiation therapy and first-line chemotherapy, have identical therapeutic options and poor outcomes with PFS-6 of 31%. Temozolomide (TMZ) has a favorable side effect profile and is available orally, however, cytotoxicity occurs. Metronomic temozolomide at low doses on a continuous schedule, have demonstrated better survival in studies. This study will determine the recommended dose and the side effects of PCI-24781/Abexinostat with metronomic temozolomide.

Sponsor: University of Nebraska

Who Can Participate

Inclusion Criteria

Pathologically proven diagnosis of high grade (aka grade III or IV) glioma (anaplastic astrocytoma, anaplastic oligodendroglioma, glioblastoma, gliosarcoma)

Prior radiation therapy and standard temozolomide; additional therapies for previous progressions are eligible (prior bevacizumab and Optune are allowed)

Three or more months from the end of chemoradiotherapy or have biopsy or imaging consistent with disease progression

19 years of age or older (the age of consent in Nebraska)

Fully recovered from any toxicity of prior therapy that, in the opinion of the investigator, could impact tolerance to the study drug

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2

Adequate bone marrow reserve (ANC count ≥1,500/mm3, hemoglobin \> 8 g/dL, platelet count ≥100,000/mm3)

Adequate renal function (a serum creatinine that is at or below 2.0 mg/dL)

Adequate hepatic function (serum AST and ALT less than 1.5 times the upper limits of normal, serum alkaline phosphatase less than 2.5 times the upper limits of normal)

Able to provide written, informed consent

Females of child-bearing potential must have a negative pregnancy test within 7 days of initiating study (non-child bearing potential is defined as age 55 years or older and no menses for two years or any age with surgical removal of the uterus and/or both ovaries)

Females of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and up to 6 months following treatment

Exclusion Criteria

Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of oral PCI-24781/Abexinostat, or put the study outcomes at undue risk

Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmia, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification

Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction

Immunotherapy, chemotherapy, radiotherapy, corticosteroids (at dosages equivalent to prednisone \> 20 mg/day) or experimental therapy (other than PCI-24781/Abexinostat PO) within 4 weeks before first dose of study drug

Concurrent use of enzyme-inducing antiepileptic drugs (phenytoin, phenobarbital, carbamazepine, felbamate, topiramate and oxcarbazepine)

Any other active malignancy other than nonmelanoma skin cancer or controlled prostate cancer

Known history of Human Immunodeficiency Virus (HIV) or active infection with Hepatitis C Virus (HCV) or Hepatitis B Virus (HBV) or any uncontrolled active systemic infection (no testing is required for eligibility)

Creatinine \> 1.5 x institutional upper limit of normal (ULN); total bilirubin \> 1.5 x ULN (unless from Gilbert's disease), and aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2.5 x ULN

Pregnant or breast-feeding

Baseline ECG duration of the ventricular action potential corrected for heart rate (QTc interval) prolongation based on Fridericia's formula is \> 450 ms in males and \> 470 ms in females

Concomitant valproic acid use, or another histone deacetylases (HDAC) inhibitor

Receiving treatment with following medications and unable to discontinue treatment or switch medications prior to study enrollment:

Amiodarone (Cordarone, Pacerone)

Arsenic trioxide (Trisenox)

Chlorpromazine (Aralen)

Cisapride (Propulsid)

Clarithromycin (Biaxin)

Disopyramide (Norpace)

Dofetilide (Tikosyn)

Doperidol (Inapsine)

Erythromycin (EryTab, Erythrocin)

Flecanide (Tambocor)

Haloperidol (Haldol)

Ibutilide (Corvert)

Methadone (Methadose, Dolophine)

Moxifloxacin (Avelox)

Pentamidine (Pentam, Nebupent)

Pimozide (Orap)

Procainamide (Procan, Pronestyl)

Quinidine (Cardioquin, Quinaglute)

Sotalol (Betapace)

Thioridazine (Mellaril)

Vandetanib (Zactima)

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 Omaha?

Yes, this clinical trial (NCT05698524) has an active research site in Omaha, NE 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 High Grade Glioma Treatment Options in Omaha, NE

If you're searching for recurrent high grade glioma treatment options in Omaha, NE, this clinical trial (NCT05698524) 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 Omaha research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced recurrent high grade 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 recurrent high grade glioma clinical trials near you to find additional studies recruiting in your area.

Recurrent High Grade Glioma Clinical Trial in Omaha, NE

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