A Study of All-Trans Retinoic Acid (ATRA) and Bryostatin in Patients With Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)
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)
2 other identifiers
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 1997
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 1997
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2000
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2000
CompletedFirst Submitted
Initial submission to the registry
August 25, 2005
CompletedFirst Posted
Study publicly available on registry
August 29, 2005
CompletedMarch 10, 2011
March 1, 2011
3.3 years
August 25, 2005
March 9, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Central nervous system abnormality.
- Uncontrolled active infection.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- Brigham and Women's Hospitalcollaborator
Study Sites (1)
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard M. Stone, MD
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 25, 2005
First Posted
August 29, 2005
Study Start
May 1, 1997
Primary Completion
August 1, 2000
Study Completion
August 1, 2000
Last Updated
March 10, 2011
Record last verified: 2011-03