Investigating the effects of DFMO and AMXT 1501 on brain tumor metabolism
Intratumoral Extracellular Metabolic Impact of DFMO and AMXT 1501
EARLY_PHASE1 · Mayo Clinic · NCT05717153
This study is testing how two drugs, DFMO and AMXT 1501, can change the metabolism of brain tumors in patients after surgery.
Quick facts
| Phase | EARLY_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic (other) |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT05717153 on ClinicalTrials.gov |
What this trial studies
This early phase I trial examines how the drugs eflornithine (DFMO) and AMXT 1501 affect the metabolism of diffuse or high-grade gliomas in patients. Participants will undergo surgical resection of their tumors, followed by treatment with DFMO and AMXT 1501, while their tumor's metabolic response is monitored through microdialysis. The study aims to assess the impact of polyamine depletion on tumor metabolism and the feasibility of using microdialysis for pharmacodynamic evaluations in glioma patients. Additionally, the pharmacokinetics and adverse effects of the drugs will be evaluated in the postoperative setting.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of diffuse high-grade glioma who are undergoing planned surgical resection.
Not a fit: Patients with low-grade gliomas or those not undergoing surgical resection may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new therapeutic strategies for treating aggressive brain tumors.
How similar studies have performed: While the approach of targeting tumor metabolism is being explored, this specific combination of drugs and methodology is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \>= 18 years * Clinical and radiographic evidence suggesting a diagnosis of a diffuse high grade glioma (HGG), or a prior diagnosis of a diffuse glioma * Planned subtotal resection or biopsy due to tumor location, size, or other clinical indication deemed appropriate by the surgeon * Provide written informed consent for the current study and the Neuro-Oncology biorepository for archiving of cerebrospinal fluid (CSF) and blood samples collected on this protocol. Willing to remain in the hospital at Mayo Clinic (Rochester, MN) for three days added to their standard post-operative stay to undergo longitudinal microdialysis * Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L without transfusion within 7 days preceding the lab assessment (obtained =\< 14 days prior to registration) * Platelet \>= 100 x 10\^9/L, without transfusion within 7 days preceding the lab assessment (obtained =\< 14 days prior to registration) * Hemoglobin \>= 9 g/dL, without transfusion support within 7 days preceding the lab assessment (obtained =\< 14 days prior to registration) * Activated partial thromboplastin time or partial thromboplastin time (aPTT or PTT) =\< 1.5 x upper limit of normal (ULN) (obtained =\< 14 days prior to registration) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x ULN (obtained =\< 14 days prior to registration) * Total serum bilirubin =\< 1.5 x ULN (obtained =\< 14 days prior to registration) * The patient is clinically euthyroid \[Thyroid Stimulating Hormone (TSH)\] * Serum creatinine =\< 1.5 x ULN or creatinine clearance \>= 60 mL/min/1.73 m\^2 for patients with serum creatinine levels above 1.5 x ULN (obtained =\< 14 days prior to registration) * Negative serum or urine pregnancy test is required for female subjects of childbearing age \< 14 days prior to registration Exclusion Criteria: * Inappropriate surgical candidates due to current or past medical history or uncontrolled concurrent illness which limits safety of or compliance to study proceedings * Vulnerable populations: pregnant or nursing women, prisoners, mentally handicapped * Unable to swallow tablets or who are at risk for impaired absorption of oral medication. NOTE: This includes but not limited to, refractory vomiting, gastric resection/bypass, and duodenal/jejunal resection * Known hypersensitivity or allergy to DFMO or AMXT 1501 * Contraindication to MRI or administration of gadolinium
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (RECRUITING)
Study contacts
- Principal investigator: Terence C. Burns, MD, PhD — Mayo Clinic in Rochester
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diffuse Glioma, Malignant Glioma