Back to resultsA Study of All-Trans Retinoic Acid (ATRA) and Bryostatin in Patients With Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)
Primary Purpose
Acute Myelogenous Leukemia, Myelodysplastic Syndrome
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
All-trans retinoic acid
Bryostatin 1
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myelogenous Leukemia focused on measuring AML, acute myelogenous leukemia, MDS, myelodysplastic syndrome, bryostatin 1, all-trans retinoic acid, ATRA
Eligibility Criteria
Inclusion Criteria: Patients with AML who have failed induction chemotherapy. Patients with secondary AML Patients with AML over age 60 who are deemed not to be a candidate for chemotherapy. Patients with any subtype of MDS. Age 18 or greater. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 Satisfactory liver and kidney function. Greater than 4 weeks from prior chemotherapy or radiation therapy. Exclusion Criteria: Central nervous system abnormality. Uncontrolled active infection.
Sites / Locations
- Dana-Farber Cancer Institute
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT00136461
First Posted
August 25, 2005
Last Updated
March 9, 2011
Sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00136461
Brief Title
A Study of All-Trans Retinoic Acid (ATRA) and Bryostatin in Patients With Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
May 1997 (undefined)
Primary Completion Date
August 2000 (Actual)
Study Completion Date
August 2000 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myelogenous Leukemia, Myelodysplastic Syndrome
Keywords
AML, acute myelogenous leukemia, MDS, myelodysplastic syndrome, bryostatin 1, all-trans retinoic acid, ATRA
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
All-trans retinoic acid
Intervention Type
Drug
Intervention Name(s)
Bryostatin 1
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with AML who have failed induction chemotherapy.
Patients with secondary AML
Patients with AML over age 60 who are deemed not to be a candidate for chemotherapy.
Patients with any subtype of MDS.
Age 18 or greater.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Satisfactory liver and kidney function.
Greater than 4 weeks from prior chemotherapy or radiation therapy.
Exclusion Criteria:
Central nervous system abnormality.
Uncontrolled active infection.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard M. Stone, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of All-Trans Retinoic Acid (ATRA) and Bryostatin in Patients With Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)
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