Status:
COMPLETED
α-TEA in Advanced Cancer
Lead Sponsor:
Providence Health & Services
Conditions:
Metastatic Carcinoma
Metastatic Sarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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. A...
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 ch...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
- QTc greater than 450 msec at baseline (calculated using Bazett's formula), sick-sinus syndrome or other active cardiac disease.
Key Trial Info
Start Date :
August 4 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 8 2018
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT02192346
Start Date
August 4 2014
End Date
May 8 2018
Last Update
August 17 2018
Active Locations (5)
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1
Providence Oncology & Hematology Care Clinic- Southeast
Clackamas, Oregon, United States, 97015
2
Providence Oncology & Hematoloty Care Clinic- Newberg
Newberg, Oregon, United States, 97132
3
Providence Oncology & Hematology Care Clinic- Willamette Falls
Oregon City, Oregon, United States, 97045
4
Providence Oncology & Hematology Care Clinic- Eastside
Portland, Oregon, United States, 97213