A Study of All-Trans Retinoic Acid (ATRA) and Bryostatin in Patients With Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)
|Acute Myelogenous Leukemia Myelodysplastic Syndrome||Drug: All-trans retinoic acid Drug: Bryostatin 1||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Phase II Trial of All-Trans Retinoic Acid and One of Two Schedules of Bryostatin 1 in Patients With Refractory Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS)|
- This study is designed to test the therapeutic effect of combining Bryostatin 1 with the known maximum tolerated dose of all-trans retinoic acid in patients with either MDS or AML.
- This study will also determine the ability of Bryostatin 1 in combination with ATRA in humans to induce differentiation of human leukemic cells and to cause changes in the levels of protein kinase C isoenzymes in these cells.
|Study Start Date:||May 1997|
|Study Completion Date:||August 2000|
|Primary Completion Date:||August 2000 (Final data collection date for primary outcome measure)|
All patients receive all-trans retinoic acid at a dose of 150 mg/m2/day and patients are randomized to one of two schedules of Bryostatin 1.
Arm 1: Bryostatin 1 is administered at a dose of 60 mcg/m2 as a 30 minute intravenous (IV) infusion on days 8 and 22.
Arm 2: Bryostatin 1 is administered at a dose of 40 mcg/m2 as a 72 hour IV infusion starting on days 8 and 22.
Patients are assessed for response on day +50 with a bone marrow examination and patients with either a clinical response or stable disease receive further therapy.
Bryostatin 1 pharmacokinetic samples are to be drawn on days 1, 8 and 50 of each cycle.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00136461
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Richard M. Stone, MD||Dana-Farber Cancer Institute|