FTS Study in Patients With Advanced Hematologic Malignancies

Leukemia Clinical Trial

Official title: A Phase I Open-Label Study of S-Trans, Trans-Farnesylthiosalicylic Acid (FTS) Administered on Days 1 to 21 of a 28 Day Cycle in Patients With Advanced Hematologic Malignancies

Status Completed

Clinical Trial Summary

Primary Objective:

Determining the maximum tolerated dose (MTD) and pharmacokinetics (PK) of FTS (S-Trans, Trans-Farnesylthiosalicylic Acid) after daily oral administration on Days 1 through 21 of a 28-Day cycle to patients with advanced hematologic malignancies that have progressed following effective therapy or for which no effective therapy exists.

Clinical Trial Description

FTS is designed to interfere with a cancer cell's ability to reproduce.

Before you can start receiving the drug on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. Your complete medical history will be recorded, and you will have a physical exam. You will be asked about any side effects that you are having and about any medications that you are taking. Your weight and vital signs (blood pressure, heart rate, breathing rate, and temperature) will be measured. Blood (about 2 tablespoons) and urine will be collected for routine tests. You will be asked about your ability to perform everyday tasks. You will have an electrocardiogram (ECG - test to measure the electrical activity of the heart). A bone marrow aspirate and/or biopsy will be collected to check the status of the disease. To collect a bone marrow aspirate and/or biopsy, an area of the hip or chest bone is numbed with anesthetic and a small amount (about 1 teaspoon) of bone marrow and bone is withdrawn through a large needle. Women who are able to have children must have a negative blood (about 1 tablespoon) or urine pregnancy test.

If you are found to be eligible for this study, you will take FTS by mouth, morning and night with food, on Days 1-21 of a 28-day study "cycle."

The amount of study drug you will receive will be based on when you enter the study. At least 3 participants will be taking FTS at the same dose level. Doses will be increased for the next group of 3 participants based on the side effects seen in the previous group. Each new group of participants will receive a higher dose level than the previous group, until a level is reached where side effects are considered to be intolerable.

After each cycle, your doctor may decide to increase your dose if you are not having intolerable side effects and you are benefitting from the study drug. If you experience intolerable side effects during any of the cycles of therapy with FTS, your dose may be reduced, delayed, or you may be taken off the study.

On Day 1 of the study, your weight and vital signs will be measured. Blood (about 1 tablespoon) will be collected for routine tests. You will not take your evening dose of FTS on Day 1.

On Days 8,15, and 22 of the first cycle, your weight and vital signs will be measured. You will be asked about any side effects that you are having, and about any medications that you are taking. On Day 15 of Cycle 1, blood (about 1 tablespoon) will also be drawn for routine tests.

During Cycle 1, on Days 1, 8, and 15, blood (about 1 tablespoon per draw) will be drawn to find out how much drug there is in your blood at different time points. This will help researchers to learn how FTS is processed by your body. This is called pharmacokinetic (PK) testing. Blood will be drawn before your morning dose of FTS, at 30, 60, and 90 minutes after taking the morning dose, and at 2, 4, 6, 8 and 24 hours after taking the morning dose. During Cycle 1, on Days 1 and 15, blood (about 3 tablespoons per draw) will be drawn to determine how FTS works against leukemia cells. This blood will be drawn before and 24 hours, after taking the morning dose on Day 1 and before you take the dose on Day 15.

On Day 1 of each cycle after Cycle 1, your weight and vital signs will be measured. Blood (about 2 tablespoons) and urine will be collected for routine tests. You will be asked about your ability to perform everyday tasks. You will be asked about any side effects that you are having, and about any medications that you are taking.

On Days 8, 15, and 22 of every cycle after Cycle 1, you will be asked about any side effects that you are having and about any medications that you are taking. On Day 15, blood (about 1 tablespoon) will also be drawn for routine tests, and your weight and vital signs will be measured.

You may remain on study for as long as you are benefiting. You will be taken off study if you are not benefitting or if you are experiencing intolerable side effects.

Thirty (30) days after you are no longer taking the study drug, you will have an end-of-study visit. Blood (about 2 tablespoons) and urine will be collected for routine tests. Your weight and vital signs will be measured. You will be asked about your ability to perform everyday tasks. You will be asked about any side effects that you are having, and about any medications that you are taking. You will have an ECG and an evaluation of your disease, which may include a bone marrow aspiration and/or biopsy.

This is an investigational study. FTS is not FDA approved or commercially available, and it has been authorized for use in research only. Up to 30 patients will take part in this multicenter study. Up to 20 patients will be enrolled at M. D. Anderson. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Preleukemia

• NCT number: NCT00867230
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Completed
• Phase: Phase 1
• Start date: May 2006
• Completion date: February 2009