Clinical trial NCT00918931
Conditions: Leukemia Systemic Mastocytosis
Keywords: Leukemia Systemic Mastocytosis SM Obatoclax mesylate GX15-070MS
Sponsor: M.D. Anderson Cancer Center
Start date: 2009-06-01; Completion date: 2010-10-01
Enrollment: 3 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The goal of this clinical research study is to learn if obatoclax mesylate can help to control systemic mastocytosis. The safety of this drug will also be tested.

Detailed description:
The Study Drug:

Obatoclax mesylate is designed to block the growth of malignant mast cells. This may cause cancer cells to die.

Study Drug Administration:

If you are found to be eligible to take part in this study, you will receive obatoclax mesylate through a peripheral intravenous catheter (a needle in the vein of your arm). The drug will be given over 3 hours each day on Days 1-3 of each 14-day study cycle.

If the study doctor thinks it is needed, you might receive the study drug though a silicone-based central venous catheter (CVC). A central venous catheter is a sterile flexible tube that will be placed into a large vein while you are under local anesthesia. Some catheters cannot be used with the study drug. If you already have one of these catheters in your body, it may need to be replaced before you can begin receiving the study drug. You will sign a separate consent that will describe the procedure and its risks in detail.

Study Visits:

One (1) time during each study cycle, the following tests and procedures will be performed:

* You will be asked about any side effects you may be having and about any other drugs you may be taking.
* Blood (about 2 tablespoons) will be drawn for routine tests.

Every 3 months while you are taking the study drug, you will have a bone marrow biopsy/aspirate to check the status of the disease.

Length of Study:

You will be able to continue receiving the study drug for as long as you are benefitting. You will be taken off study if you have intolerable side effects or if the disease gets worse.

Follow-Up:

Three months after your last dose of study drug, your doctor will call you to ask you how you are feeling. This call should take about 10 minutes.

Additional Information:

* You must tell your doctor about any drug allergies you may have.
* You must tell your doctor about how much alcohol you consume and about any other drugs you may be taking, including vitamins, herbal remedies, and over-the-counter, prescription, and/or illegal drugs. Some of these will interact with the study drug.
* You must arrange to have someone drive you home after each treatment. You must not drive or operate machinery (including kitchen appliances) after you have received the study drug until any possible side effects have gone away.
* If you feel you any side effects or symptoms while you are on study, you must contact your doctor right away.

This is an investigational study. Obatoclax mesylate is not FDA approved or commercially available. At this time, obatoclax mesylate is only being used in research.

Up to 25 patients will take part in this study. All will be enrolled at M. D. Anderson.

Arms: arm 1: 30 mg by vein over 3 hours Days 1-3, 14-day cycle
Interventions: intervention 1: Obatoclax Mesylate
Intervention descriptions: intervention 1: 30 mg given by vein over 3 hours on Days 1-3 of each 14-day study cycle.

Protocol documents: