Clinical Trial: Obatoclax for Systemic Mastocytosis

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Evaluation of Obatoclax Mesylate as Therapy for Patients With Systemic Mastocytosis

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 Summary:

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 abl
Sponsor: M.D. Anderson Cancer Center

Current Primary Outcome: Response Rate [ Time Frame: 3-Month Response Evaluation ]

Response rate is defined as number of participants with objective response divided by number of participants evaluated. Objective response is complete response and partial response where 'complete response' constitutes total elimination of a symptom or sign of the disease; 'partial response' constitutes at least 50% improvement in a symptom or sign of the disease. Objective response definitions of response evaluated following guidelines proposed by Valent et al. (International working group consensus criteria).


Original Primary Outcome: Response Rate [ Time Frame: 3-Month Response Evaluation ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: M.D. Anderson Cancer Center

Dates:
Date Received: June 9, 2009
Date Started: June 2009
Date Completion:
Last Updated: October 14, 2011
Last Verified: October 2011