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.
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.
- 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.
- Central nervous system abnormality.
- Uncontrolled active infection.