Clinical Trial: Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of Nelarabine in Patients With Relapsed/Refractory Lymphoid Malignancies

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Pharmacokinetic and Pharmacodynamic Study to Evaluate the Safety and Feasibility of Continuous Infusion Nelarabine in Patients With Relapsed / Refractory Lymphoid Malignancies

Brief Summary: The goal of the clinical research study is to find the highest tolerable dose of nelarabine when given as a continuous infusion to patients with a lymphoid malignancy that has not responded to, or has come back after treatment with chemotherapy. The safety of this drug will also be studied.

Detailed Summary:

The Study Drug:

Nelarabine is designed to interfere with DNA (the genetic material of cells) and stop the growth of rapidly dividing cells, such as cancer cells.

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to a dose level of nelarabine based on when you joined this study. Up to 8 dose levels of nelarabine will be tested. Three (3) to 6 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 nelarabine is found.

Study Drug Administration:

You will receive nelarabine as a non-stop infusion through a needle or catheter in your vein on Days 1-5 of each 4 - 6 week cycle. You will remain in the hospital for this infusion.

You may receive ondansetron or a similar drug by vein over about 30 minutes before you receive nelarabine. This is given to help prevent nausea. You will also take ondansetron or a similar drug by mouth every 12 hours for the next 7 days as needed. If you are still having nausea, you will be given additional drugs.

If you are not allergic, you may receive allopurinol by mouth on Days 1-10 of Cycles 1. Allopurinol is given to help reduce the risk of too much uric acid in the blood. If the level of uric acid in the blood is too high, you may receive additional drugs.

You may also be given drugs to help reduce the risk of infection.

MTD defined as the highest dose that no more than 1 dose limiting toxicity (DLT) occurs among 6 patients. Dose-limiting toxicity (DLT) defined based on drug related events only. DLT in the first treatment cycle used for the dose escalation.