Phase 2 Study of Sitagliptin for Patients with Advanced Brain Tumors (Grade 4 Gliomas)

Sponsor: Case Comprehensive Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT07003542

Provider View

This study is testing if the drug sitagliptin can help the immune system fight against aggressive brain tumors called glioblastomas by targeting specific immune cells that weaken the body's natural defenses against cancer.

Patient Parameters

Program Overview

The study aims to see if sitagliptin, a drug usually used for diabetes, can help the immune system fight glioblastoma, a type of aggressive brain tumor. Sitagliptin works by blocking an enzyme that certain immune cells need to enter the brain and suppress the immune response. While sitagliptin is approved for diabetes, its use in brain cancer is experimental.

Description

Glioblastoma is a type of brain cancer that makes it hard for the immune system to fight back. This is partly because of special immune cells called myeloid-derived suppressor cells (MDSCs) that stop the immune system from attacking the tumor. Patients with glioblastoma have more of these cells compared to those with less aggressive brain tumors. Research has shown that reducing these cells can help the immune system work better against the tumor. Sitagliptin, a drug that blocks an enzyme these cells need, might help reduce their numbers and improve the immune response. This study will test sitagliptin in patients with recurrent grade 4 glioma who are having surgery to remove the tumor. 48 patients will participate: 36 will receive sitagliptin before surgery, and 12 will not. All patients will receive sitagliptin and chemotherapy after surgery until the disease progresses.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of grade 4 glioma and be scheduled for tumor removal surgery.
  • Must not have taken sitagliptin or similar drugs before.
  • Must be able to tolerate a specific dose of the steroid dexamethasone.
  • Must be over 18 years old.
  • Must have a performance status score of 60% or higher, meaning they can carry out most daily activities.
  • Must have adequate organ function and meet specific blood test criteria.
  • Women of childbearing age must have a negative pregnancy test and agree to use birth control during the study.
  • Must be able to swallow tablets.
  • Must have waited a certain amount of time after previous treatments before starting the study.
  • HIV-positive participants must have an undetectable viral load and be on stable treatment.
  • Participants with hepatitis C or B must have an undetectable viral load if on treatment.
  • Must be eligible for chemotherapy after surgery.
  • Must understand and agree to the study requirements.

Exclusion Criteria

  • Must not have unresolved side effects from previous treatments, except for hair loss or mild nerve damage.
  • Must not be taking other experimental drugs.
  • Must not have allergies to sitagliptin or similar drugs.
  • Must not have uncontrolled diabetes or need insulin or certain diabetes medications.
  • Must not have a history of severe low blood sugar.
  • Must not have other serious health conditions that could interfere with the study.
  • Must not have other cancers that could affect the study results.
  • Must not have significant digestive issues causing diarrhea.
  • Must not be pregnant or breastfeeding.
  • Must be able to swallow tablets.
  • Must not have any medical or psychiatric conditions that would make participation inappropriate.

Locations

FACILITYZIPCITYSTATE
Case Comprehensive Cancer Center, Cleveland Clinic Foundation Taussig Cancer Institute44195ClevelandOhio

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