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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Patients receive oral α-TEA 2.4 mg/kg daily for the first 14 days of a 28 day cycle.
Patients will receive oral α-TEA 4.8 mg/kg daily for the first 14 days of a 28 day cycle.
Patients will receive oral α-TEA 8.0 mg/kg daily for the first 14 days of a 28 day cycle.
Providence Oncology & Hematology Care Clinic- Southeast
Clackamas, Oregon, United States
Providence Oncology & Hematoloty Care Clinic- Newberg
Newberg, Oregon, United States
Providence Oncology & Hematology Care Clinic- Willamette Falls
Oregon City, Oregon, United States
Providence Oncology & Hematology Care Clinic- Eastside
Portland, Oregon, United States
Number of Participants with Adverse Events
Patients are seen in clinic 7 times over a 28-day period. Patients will have 6 physical exams and meet with a research nurse 5 times for evaluation of any potential drug-related toxicities. In addition, blood will be drawn 7 times for complete blood counts and metabolic panel to check for hematological toxicities. After 28 days, a review of all safety data will determine whether the dose will be increased for subsequent patients.
Time frame: 28 Days
Number of Adverse Events Possibly Caused by α-TEA
Patients are seen in clinic 7 times over a 28-day period. Patients will have 6 physical exams and meet with a research nurse 5 times for evaluation of any potential drug-related toxicities. In addition, blood will be drawn 7 times for complete blood counts and metabolic panel to check for hematological toxicities. This information will be used to identify toxicities of α-TEA and characterize the safety profile.
Time frame: 28 days
Blood serum levels of α-TEA
Patients will have 11 blood draws over 28 days for evaluation of pharmacokinetics. High-performance liquid chromatography (HPLC) and mass spectrometry detection (MSD) will be used to determine serum drug levels of α-TEA using blood samples collected just before the first dose of α-TEA and 1, 4, 8, and 24 hours after the first dose. Additional samples will be drawn just before the α-TEA dose on Days 2, 5, 8, 15, 22, and 29.
Time frame: 28 days
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Patients will receive oral α-TEA 9.6 mg/kg daily for the first 14 days of a 28 day cycle.
Patients will receive oral α-TEA 12 mg/kg daily for the first 14 days of a 28 day cycle.
Patients will receive oral α-TEA 16.8 mg/kg daily for the first 14 days of a 28 day cycle.
Patients will receive oral α-TEA 19.2 mg/kg daily for the first 14 days of a 28 day cycle.
Patients will receive oral α-TEA 22.3 mg/kg daily for the first 14 days of a 28 day cycle.
Patients will receive oral α-TEA 26.8 mg/kg daily for the first 14 days of a 28 day cycle.
Providence Oncology & Hematology Care Clinic- Westside
Portland, Oregon, United States