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α-TEA in Advanced Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1

α-TEA in Advanced Cancer

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

NCT02192346•Providence Health & Services

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients with measurable or evaluable metastatic carcinoma, sarcoma or lymphoma who have malignancy refractory or progressed after therapy and for whom no other standard (non-experimental) therapy exists or who have declined available standard therapy, with potential to induce cure, remission or enhanced survival. Either histologic or cytologic diagnosis is acceptable of the primary cancer, or clinical evidence of metastasis.
•Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
•Age 18 years or above.
•Laboratory values (performed within 28 days prior to enrollment) within protocol specified range.
•Confirmed radiographic and/or serum marker showing cancer progression after at least one systemic therapy for metastatic disease.
•Ability to give informed consent and comply with the protocol. Patients with a history of psychiatric illness must be judged able to understand the investigational nature of the study and the risks associated with the therapy.
•No active bleeding.
•No coagulopathy (INR \<1.5, PT \<16 seconds, PTT \< 38 seconds) at baseline.
•Anticipated lifespan greater than 12 weeks.
•Ability to swallow capsules
+1 more criteria

Exclusion Criteria

•Active serious infection that could affect treatment.
•Coagulopathy or need for anti-coagulation therapy.
•Malabsorbtion state such as ulcerative colitis, previous surgical resection of \> 20% of intestine or stomach.
•History of or active atrial fibrilliationfibrillation or supraventricular tachycardia
•Cardiac ejection fraction less than the lower limit of normal on echocardiography
•Right atrial enlargement on echocardiography
•Active cardiac ischemia. Patients with a history of ischemia ameliorated with stent placement or coronary artery bypass grafting and who have no evidence of ischemia by exercise or physiological stress testing are eligible.
•History of or active congestive heart failure
•Patients with tumor that has invaded vagal nerve, carotid bodies, mediastinal structures, pericardium or myocardium.
•Abnormal thyroid function, or euthyroid, but are on medication for thyroid disorders
+5 more criteria

Locations (5)

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

Providence Oncology & Hematology Care Clinic- Westside

Portland, Oregon, United States

Key Dates

Start Date

August 4, 2014

Primary Completion Date

December 11, 2017

Completion Date

May 8, 2018

Last Updated

August 17, 2018

Enrollment

ACTUAL participants

Conditions

Metastatic CarcinomaMetastatic SarcomaMetastatic Lymphoma

Interventions

2.4 mg/kg α-TEA

DRUG

4.8 mg/kg α-TEA

DRUG

8.0 mg/kg α-TEA

DRUG

9.6 mg/kg α-TEA

DRUG

12 mg/kg α-TEA

DRUG

16.8 mg/kg α-TEA

DRUG

19.2 mg/kg α-TEA

DRUG

22.3 mg/kg α-TEA

DRUG

26.8 mg/kg α-TEA

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 17, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

α-TEA in Advanced Cancer

Inclusion Criteria

Exclusion Criteria

Targeted Oligometastatic Radiation in Pediatric and Young Adult Patients With Soft Tissue and Bone Sarcoma

Testing the Anti-cancer Drug, Rogaratinib (BAY 1163877), for Treatment of Advanced Sarcoma With Alteration in Fibroblast Growth Factor Receptor (FGFR 1-4), and in Patients With SDH-deficient Gastrointestinal Stromal Tumor (GIST)

CBM588 in Combination With Nivolumab and Cabozantinib for the Treatment of Advanced or Metastatic Kidney Cancer

BMS-986156, Ipilimumab, and Nivolumab With or Without Stereotactic Body Radiation Therapy in Treating Patients With Advanced or Metastatic Lung/Chest or Liver Cancers

Stereotactic MRI-guided Adaptive Radiation Therapy (SMART) in One Fraction

Multi-Arm Study to Test the Efficacy of Immunotherapeutic Agents in Multiple Sarcoma Subtypes