α-TEA in Advanced Cancer

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

Interventions

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.

Sponsors & Collaborators

• Providence Health & Services

  lead OTHER

Principal Investigators

• Brendan Curti, MD · Providence Cancer Center, Earle A. Chiles Reserach Institute at the Robert W. Franz Cancer Center

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-08-04

Primary Completion

2017-12-11

Completion

2018-05-08

Countries

• United States

Study Locations