Chronic CED of TPT for Recurrent Malignant Glioma

The primary goal of this study is to establish the safety of chronic Convection Enhanced Delivery (CED) of the chemotherapeutic drug Topotecan for patients with recurrent malignant glioma that harbors the Isocitrate Dehydrogenase mutation (IDH-mut). The secondary goal of the study is to study drug distribution and assess the tumor response to prolonged continuous CED of Topotecan. Convection Enhanced Delivery is a novel method of drug delivery that allows administration of a drug directly to the brain. In CED, a drug pump is placed under the skin in the chest or abdominal region. The pump is

Trial Details

NCT ID
NCT06666712
Phase
PHASE1
Sponsor
Jeffrey N. Bruce
Status
RECRUITING
Cancer Type
Glioblastoma (GBM) Brain Cancer
Locations (sample)
  • New York, New York, United States|40.71427,-74.00597

Key Eligibility Criteria

  • Patients must have recurrent malignant glioma with a history of WHO grade 3-4 IDH-mutant status and evidence of radiographic progression and suspic…
  • Patients with recurrent malignant glioma, IDH-mutant, who have failed standard of care treatment are eligible.
  • An MRI scan must be obtained within 30 days of enrollment and must demonstrate an enhancing mass without significant mass effect. Tumors must be le…
  • Karnofsky performance score must be greater than or equal to 70.

For full eligibility, visit ClinicalTrials.gov.

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