DB-67 in Myelodysplastic Syndrome (MDS)
The goal of this clinical research study is to learn if AR-67 can help to control Myelodysplastic Syndrome (MDS).
1. Evaluate the response rate of AR-67 in MDS.
- Evaluate the safety of AR-67 in patients with MDS.
- Evaluate the survival and disease-free survival of patients with MDS treated with AR-67.
- Evaluate the response duration of patients with MDS treated with AR-67.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of AR-67 (DB-67) in Myelodysplastic Syndrome (MDS)|
- Response Rate [ Time Frame: 4 cycles (approximately 16 weeks) ] [ Designated as safety issue: No ]
- Toxicity Rate [ Time Frame: 4 cycles (approximately 16 weeks) ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2009|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
AR-67 dose of 7.5 mg/m^2 IV over 1 hour daily for 5 days of each 28-day study cycle.
Drug: AR-67 (DB-67)
Dose of 7.5 mg/m^2 IV over 1 hour daily for 5 days of each 28-day study cycle
The Study Drug:
AR-67 is designed to block the function of an important protein (topoisomerase I) in cancer cells that helps repair damage to DNA (the genetic material of cells). When this protein is blocked, cancer cells may die.
Study Drug Administration:
If you are found to be eligible to take part in this study, on Days 1-5 of each 28-day study "cycle", you will receive AR-67 through a needle into the vein or a central venous catheter (CVC) into your vein over about 1 hour. A CVC is a sterile flexible tube that will be placed into a large vein while you are under local anesthesia. Your doctor will explain this procedure to you in more detail, and you will be required to sign a separate consent form for this procedure.
On Days 6-28 of each cycle, you will receive no study drug.
If your doctor thinks it is needed, your study cycles may be shortened so that you will receive the study drug more often.
Before the start of each cycle, you will have a physical exam and your medical history will be recorded.
Once or twice every week of Cycle 1 and then every 2-4 weeks after that, blood (about 2 tablespoons each time) will be drawn for routine tests.
At the end of Cycle 1, and then once every 1-3 cycles, you will have a bone marrow aspirate and/or biopsy to check the status of the disease.
If you take the study drug for more than 12 months, you will have bone marrow aspirates and biopsies every 6-12 months. They may be performed more often if the study doctor thinks it is needed.
Length of Study:
You may continue taking the study drug for as long as you are benefitting. You will be taken off study if the disease gets worse or you experience intolerable side effects.
This is an investigational study. AR-67 is not FDA approved or commercially available. At this time, AR-67 is only being used in research.
Up to 25 participants will take part in this study. All will be enrolled at M. D. Anderson.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00930540
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||Jorge Cortes, MD||UT MD Anderson Cancer Center|