NCT02192346

α-TEA in Advanced Cancer

Phase I Study of Alpha-tocopheryloxyacetic Acid (α-TEA) in Patients With Advanced Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Providence Health & Services · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to find the highest dose of α-TEA that can be given to patients safely, to identify potential side effects of α-TEA, and to measure the amount of α-TEA in patients' blood. Additional goals of this study are to monitor the effect on tumors, to check for specific immune cells circulating in the blood, and to see if there are certain features of tumors that make it possible to predict the response to α-TEA.

Detailed description

This is a dose-escalation study in which doses ranging from 2.4 mg/kg to 26.8 mg/kg of α-TEA will be tested. The main clinical objectives of this phase I two-stage dose-escalation trial will be to characterize α-TEA related toxicity, determine the maximum tolerated dose, and pharmacokinetics of α-TEA in humans. Tumor response and exploratory immunological monitoring will also be performed. Specifically, we will determine the frequency of circulating peripheral T cell subset populations including CD4+, CD8+ T cells and their activation status (central memory, effector cells) and regulatory T cells (CD4/CD25/Foxp3). Exploratory monitoring to assess tumor apoptosis and serum cytokine levels will also be performed to gain additional insight on the influence of α-TEA on the immune response and tumor. An assessment of the immunoscore in patients with tumor amenable to biopsy will also provide hypothesis-generating data on the influence of α-TEA on the tumor microenvironment.

Conditions

• Metastatic Carcinoma
• Metastatic Sarcoma
• Metastatic Lymphoma

Interventions

Type	Name	Description
DRUG	2.4 mg/kg α-TEA	Patients receive oral α-TEA 2.4 mg/kg daily for the first 14 days of a 28 day cycle.
DRUG	4.8 mg/kg α-TEA	Patients will receive oral α-TEA 4.8 mg/kg daily for the first 14 days of a 28 day cycle.
DRUG	8.0 mg/kg α-TEA	Patients will receive oral α-TEA 8.0 mg/kg daily for the first 14 days of a 28 day cycle.
DRUG	9.6 mg/kg α-TEA	Patients will receive oral α-TEA 9.6 mg/kg daily for the first 14 days of a 28 day cycle.
DRUG	12 mg/kg α-TEA	Patients will receive oral α-TEA 12 mg/kg daily for the first 14 days of a 28 day cycle.
DRUG	16.8 mg/kg α-TEA	Patients will receive oral α-TEA 16.8 mg/kg daily for the first 14 days of a 28 day cycle.
DRUG	19.2 mg/kg α-TEA	Patients will receive oral α-TEA 19.2 mg/kg daily for the first 14 days of a 28 day cycle.
DRUG	22.3 mg/kg α-TEA	Patients will receive oral α-TEA 22.3 mg/kg daily for the first 14 days of a 28 day cycle.
DRUG	26.8 mg/kg α-TEA	Patients will receive oral α-TEA 26.8 mg/kg daily for the first 14 days of a 28 day cycle.

Timeline

• Start date: 2014-08-04
• Primary completion: 2017-12-11
• Completion: 2018-05-08
• First posted: 2014-07-16
• Last updated: 2018-08-17

Locations

5 sites across 1 country: United States