NCT02654964

Cancer Stem Cell High-Throughput Drug Screening Study

A Phase 0/1 Study of Combination Drug Therapy For Glioblastoma Based on Personalized Cancer Stem Cell (CSC) High-Throughput Drug Screening (HTS)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Swedish Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A study to determine the safety of CSC/ HTS-based combination drug therapy in subjects who have GBM that has recurred or progressed following prior radiation therapy and TMZ.

Detailed description

This protocol describes a prospective single-center Phase 0/1 open-label study to evaluate the safety and efficacy of a high-throughput drug sensitivity assay to predict targeted therapies for patients who have GBM that has recurred or progressed following prior radiation therapy and TMZ. The underlying hypothesis is that treatment of patients with up to 3 lead candidates identified from individualized CSC/ HTS assays will safely (1) delay disease progression, and (2) increase survival. There is an abundance of literature strongly supporting the importance of a regimen for targeting CSCs and preventing tumor recurrence, as an additional strategy to improve the overall prognosis of cancer patients.

Conditions

• Glioblastoma Multiforme

Interventions

Type	Name	Description
DRUG	Combination Drug Therapy	Up to 3 of 73 possible interventions from the drug classes listed below will be selected based on their potency against CSCs, potential for synergy without cross-reactive toxicities, drug safety profiles, pharmacokinetics, and drug-drug interactions. Those patients that have GBM that has recurred (as defined by RANO (45)), and for whom HTS was successfully completed, will be eligible to continue to the treatment component of the study to receive the drug cocktail comprised from the following drug classes: Antineoplastic Anti-infective Antiemetic Antihyperlipidemic Anti-inflammatory Antihistamine Antihypertensive Antidepressant Cardiotonic Alcohol antagonist Diuretic Antipsychotic NMDA receptor antagonist Antidiabetic Immunosuppressant Anticonvulsant Antimethemoglobinemic Sclerosing agent

Timeline

• Start date: 2015-12-01
• Primary completion: 2021-11-01
• Completion: 2023-06-01
• First posted: 2016-01-13
• Last updated: 2024-04-10

Locations

1 site across 1 country: United States