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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | August 25, 2005 | ||||
| Last Updated Date | January 6, 2009 | ||||
| Start Date ICMJE | May 1997 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
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. | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00136461 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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. | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Study of All-Trans Retinoic Acid (ATRA) and Bryostatin in Patients With Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) | ||||
| Official Title ICMJE | 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) | ||||
| Brief Summary | The purpose of this study is to assess the effects of the combination of all-trans retinoic acid in combination with one of two schedules of Bryostatin 1 in patients with myelodysplasia and acute myelogenous leukemia. |
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| Detailed Description | 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. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 40 | ||||
| Completion Date | August 2000 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00136461 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 96-278, NCI# T96-0112 | ||||
| Study Sponsor ICMJE | Dana-Farber Cancer Institute | ||||
| Collaborators ICMJE | Brigham and Women's Hospital | ||||
| Investigators ICMJE |
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| Information Provided By | Dana-Farber Cancer Institute | ||||
| Verification Date | December 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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