A Phase 2 and Pharmacodynamic Study of Sitagliptin in Patients With Progressive Grade 4 Gliomas
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCase Comprehensive Cancer Center
About this trial
The purpose of this study is to evaluate whether treating glioblastoma patients with sitagliptin can improve immune response against the tumor by targeting specific immune cells called myeloid-derived suppressor cells (MDSCs) that suppress your body's natural immune response against cancer.
Sitagliptin is an investigational drug for this condition that works by inhibiting an enzyme called dipeptidyl peptidase 4 (DPP-4), which MDSCs rely on to enter the brain and function. While sitagliptin is FDA-approved for diabetes treatment, its use in glioblastoma is investigational (experimental).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants must have histologically or cytologically confirmed WHO grade 4 glioma (including tumors with molecularly defined grade 4 astrocytoma) for whom a clinically-indicated tumor resection is planned.
Participants must not have received sitagliptin or other gliptins.
Participants must, in the opinion of the investigator be able to tolerate a pre-operative dexamethasone dose of 4 mg/d or the equivalent dose of an alternate glucocorticoid.
Age >18 years
Disqualifiers
Prior treatment toxicities not resolved to ≤ Grade 1 according to NCI CTCAE Version 5.0 except alopecia and neuropathy.
Participants receiving any other investigational agents.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to sitagliptin.
Participants with uncontrolled diabetes mellitus
Trial design
Design model
Parallel
Treatments tested in this trial
Sitagliptin
DrugSitagliptin will be self-administered orally by participants. Dose level - sitagliptin * 1 100 mg daily * -1 50 mg daily * -2 25 mg daily
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: Group 1: Presurgical and post surgical treatment with sitagliptinExperimental treatment 1 intervention
Group B: Group 2: Post surgical treatment with sitagliptinExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Difference in tumor CD8+ T cell count between the participants randomized to pre-surgical sitagliptin versus the participants randomized to no pre-surgical treatment.
Time frame
Up to day 1 postsurgicalSecondary outcomes
1
Progression-free survival rate at 6 months
Time frame
6 months post intervention2
Overall survival at 12 months
Time frame
12 months post intervention3
Overall survival rate after sitagliptin administration concurrent with chemotherapy for progressive GBM.
Time frame
12 months post intervention4
Number of adverse events
CTCAEv5.0 adverse events observed with standard dose Sitagliptin administration concurrent with chemotherapy for progressive GBM.
Time frame
Up to 30 days after treatment has been discontinued or until death, whichever occurs first.Sponsors and contacts
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Source ClinicalTrials.gov