A Study of All-Trans Retinoic Acid (ATRA) and Bryostatin in Patients With Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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