A Phase I Study of Phenethyl Isothiocyanate (PEITC) in Patients With Lymphoproliferative Disorders Previously Treated With Fludarabine
The Study Drug:
PEITC is designed to cause build-up of specific molecules in cells, which may damage cancer
cells and cause the cells to die.
Study Drug Dose Levels:
If you are found to be eligible to take part in this study, you will be assigned to a dose
level of PEITC based on when you joined this study. Up to 9 dose levels of PEITC will be
tested. Three (3) participants will be enrolled at each dose level. The first group of
participants will receive the lowest dose level. Each new group will receive a higher dose
than the group before it, if no intolerable side effects were seen. This will continue
until the highest tolerable dose of PEITC is found.
Study Drug Administration:
Every 28 days in this study is 1 "cycle." You will take PEITC capsules by mouth, 4 times a
day, on Days 1-3 and 8-10 of each cycle. You should take each dose with a cup (8 ounces) of
water, either with or without food. The doses should be taken at the same times each day
(about 7:00 AM, 12 noon, 5:00 PM, and 10:00 PM).
Once a week, blood (about 1 tablespoon each time) will be drawn for routine tests. These
weekly blood draws will occur on Days 1, 8, 15, and 21 of each cycle, +/- 3 days.
Follow-up After Completion of Cycle 3:
Four (4) weeks after the start of the third cycle, the following tests and procedures will
- You will have a complete physical exam, including measurement of vital signs (blood
pressure, heart rate, temperature, and breathing rate).
- Blood (about 1 tablespoon) will be drawn for routine tests.
- If the doctor thinks it is needed, you will have a bone marrow aspiration, fine-needle
aspiration (FNA), and/or biopsy in order to check the status of the disease.
PK and PD Testing:
This study involves blood draws for pharmacokinetic (PK) and pharmacodynamic (PD) testing.
PK testing measures the amount of study drug in the body at different time points. PD
testing is used to look at how the level of study drug in your body may affect the disease.
Blood (about 1 tablespoon each time) will be drawn and used for both of these tests, on the
- Day 1 of Cycle 1 (or possibly the day before Day 1)
- Days 1, 2, and 3 of Cycle 1 (at 4 hours after that day's first dose of PEITC)
- Day 4 of Cycle 1 (at 12 hours after your last dose of PEITC)
Length of Study Participation:
You may receive up to 6 cycles (24 weeks) of the study drug. You will be taken off the
study drug early if the disease gets worse or you experience intolerable side effects.
At the end of your last study cycle, you will have a complete physical exam, including
measurement of your vital signs.
In addition, unless the disease has completely responded, the following tests and procedures
will be performed at the end-of-study visit:
- Blood (about 2 teaspoons) will be drawn for routine tests.
- You will have a bone marrow aspiration and/or biopsy to check the status of the
disease, if the study doctor thinks it is necessary.
Every 3 to 6 months after the end of your last study cycle, you will have a bone marrow
aspiration and/or biopsy if the study doctor thinks it is necessary to check the status of
the disease in this way.
Every 3 to 6 months after the end of your last study cycle, you will have a complete
physical exam, including measurement of vital signs.
After the follow-up visit at 24 weeks after the end of your last study cycle, the schedule
of your follow-up physical exams will be every 3 to 6 months. These visits may include a
blood draw and bone marrow aspiration. Your study doctor will decide if these tests are
needed. If the disease returns during this time, however, you will be considered off-study.
This means you will also no longer have the follow-up bone marrow samples collected as part
of this study.
This is an investigational study. PEITC is not commercially available or FDA approved. At
this time, it is only being used in research.
Up to 54 patients will take part in this study. All will be enrolled at M. D. Anderson.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose (MTD)
28 Day Cycle
Apostolia M. Tsimberidou, MD, PHD
UT MD Anderson Cancer Center
United States: Institutional Review Board