α-TEA in Advanced Cancer

NCT02192346 | Completed Phase 1

• 1 other identifier: 14-043A
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Metastatic Carcinoma; Metastatic Sarcoma; Metastatic Lymphoma

Keywords

metastatic; refractory; progressive

Outcome Measures

Primary Outcomes (1)

• 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.

  28 Days

Secondary Outcomes (2)

• Number of Adverse Events Possibly Caused by α-TEA

  28 days

• Blood serum levels of α-TEA

  28 days

Other Outcomes (3)

• Change in Tumor burden from baseline to 28 days

  28 Days

• Change in Activity and Proliferation of Circulating T cell Sub-Populations

  28 days

• Change in the Number of Tumor-Infiltrating T cells from Baseline to 35 days

  35 days

Study Arms (9)

2.4 mg/kg α-TEA

EXPERIMENTAL

Patients will receive oral α-TEA 2.4 mg/kg daily for the first 14 days of a 28 day cycle.

Drug: 2.4 mg/kg α-TEA

4.8 mg/kg α-TEA

EXPERIMENTAL

Patients will receive oral α-TEA 4.8 mg/kg daily for the first 14 days of a 28 day cycle.

Drug: 4.8 mg/kg α-TEA

8.0 mg/kg α-TEA

EXPERIMENTAL

Patients will receive oral α-TEA 8.0 mg/kg daily for the first 14 days of a 28 day cycle.

Drug: 8.0 mg/kg α-TEA

9.6 mg/kg α-TEA

EXPERIMENTAL

Patients will receive oral α-TEA 9.6 mg/kg daily for the first 14 days of a 28 day cycle.

Drug: 9.6 mg/kg α-TEA

12 mg/kg α-TEA

EXPERIMENTAL

Patients will receive oral α-TEA 12 mg/kg daily for the first 14 days of a 28 day cycle.

Drug: 12 mg/kg α-TEA

16.8 mg/kg α-TEA

EXPERIMENTAL

Patients will receive oral α-TEA 16.8 mg/kg daily for the first 14 days of a 28 day cycle.

Drug: 16.8 mg/kg α-TEA

19.2 mg/kg α-TEA

EXPERIMENTAL

Patients will receive oral α-TEA 19.2 mg/kg daily for the first 14 days of a 28 day cycle.

Drug: 19.2 mg/kg α-TEA

22.3 mg/kg α-TEA

EXPERIMENTAL

Patients will receive oral α-TEA 22.3 mg/kg daily for the first 14 days of a 28 day cycle.

Drug: 22.3 mg/kg α-TEA

26.8 mg/kg α-TEA

EXPERIMENTAL

Patients will receive oral α-TEA 26.8 mg/kg daily for the first 14 days of a 28 day cycle.

Drug: 26.8 mg/kg α-TEA

Interventions

2.4 mg/kg α-TEA DRUG

Patients receive oral α-TEA 2.4 mg/kg daily for the first 14 days of a 28 day cycle.

2.4 mg/kg α-TEA

4.8 mg/kg α-TEA DRUG

Patients will receive oral α-TEA 4.8 mg/kg daily for the first 14 days of a 28 day cycle.

4.8 mg/kg α-TEA

8.0 mg/kg α-TEA DRUG

Patients will receive oral α-TEA 8.0 mg/kg daily for the first 14 days of a 28 day cycle.

8.0 mg/kg α-TEA

9.6 mg/kg α-TEA DRUG

Patients will receive oral α-TEA 9.6 mg/kg daily for the first 14 days of a 28 day cycle.

9.6 mg/kg α-TEA

12 mg/kg α-TEA DRUG

Patients will receive oral α-TEA 12 mg/kg daily for the first 14 days of a 28 day cycle.

12 mg/kg α-TEA

16.8 mg/kg α-TEA DRUG

Patients will receive oral α-TEA 16.8 mg/kg daily for the first 14 days of a 28 day cycle.

16.8 mg/kg α-TEA

19.2 mg/kg α-TEA DRUG

Patients will receive oral α-TEA 19.2 mg/kg daily for the first 14 days of a 28 day cycle.

19.2 mg/kg α-TEA

22.3 mg/kg α-TEA DRUG

Patients will receive oral α-TEA 22.3 mg/kg daily for the first 14 days of a 28 day cycle.

22.3 mg/kg α-TEA

26.8 mg/kg α-TEA DRUG

Patients will receive oral α-TEA 26.8 mg/kg daily for the first 14 days of a 28 day cycle.

26.8 mg/kg α-TEA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Women of childbearing potential must have a negative pregnancy test and must avoid becoming pregnant while on α-TEA and for 4 weeks after the last dose of α-TEA. Men must avoid fathering a child while on α-TEA and for 4 weeks after the last dose of α-TEA.

You may not qualify if:

• 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
• Need for chronic high dose maintenance oral steroids. Stable treatment with prednisone ≤ 10 mg daily (or a biologically-equivalent dose of another steroid) is allowed. Patients who require brief courses of steroids to manage allergic reaction to intravenous contrast used in radiographic studies are eligible. Patients requiring steroids for management of CNS metastatic disease are not eligible.
• Surgery or severe trauma within 4 weeks of study entry (minimally invasive procedures acceptable).
• Active brain metastatic disease. Patients with brain metastases who have been treated with surgery, gamma-knife radiosurgery or radiation and no radiographic progression for at least 4 weeks and off steroids are eligible.
• Any medical or psychiatric condition that in the opinion of the PI would preclude compliance with study procedures.
• Vitamin E supplements

Sponsors & Collaborators

• Providence Health & Services: lead

Study Sites (5)

Providence Oncology & Hematology Care Clinic- Southeast

Clackamas, Oregon, 97015, United States

Location

Providence Oncology & Hematoloty Care Clinic- Newberg

Newberg, Oregon, 97132, United States

Location

Providence Oncology & Hematology Care Clinic- Willamette Falls

Oregon City, Oregon, 97045, United States

Location

Providence Oncology & Hematology Care Clinic- Eastside

Portland, Oregon, 97213, United States

Location

Providence Oncology & Hematology Care Clinic- Westside

Portland, Oregon, 97225, United States

Location

Related Links

• Providence Cancer Center

MeSH Terms

Conditions

Carcinoma; Sarcoma; Lymphoma; Neoplasm Metastasis

Interventions

2,5,7,8-tetramethyl-2R-(4R,8R,12-trimethyltridecyl)chroman-6-yloxy acetic acid

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Connective and Soft Tissue; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Brendan Curti, MD

  Providence Cancer Center, Earle A. Chiles Reserach Institute at the Robert W. Franz Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2014
• First Posted: July 16, 2014
• Study Start: August 4, 2014
• Primary Completion: December 11, 2017
• Study Completion: May 8, 2018
• Last Updated: August 17, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)