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)
18 Years
N/A
Both
Acute Myelogenous Leukemia, Myelodysplastic Syndrome
Trial Information
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)
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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.
Principal Investigator
Richard M. Stone, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Dana-Farber Cancer Institute
Authority:
United States: Food and Drug Administration
Study ID:
96-278
NCT ID:
NCT00136461
Start Date:
May 1997
Completion Date:
August 2000
Related Keywords:
- Acute Myelogenous Leukemia
- Myelodysplastic Syndrome
- AML
- acute myelogenous leukemia
- MDS
- myelodysplastic syndrome
- bryostatin 1
- all-trans retinoic acid
- ATRA
- Leukemia
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
- Myelodysplastic Syndromes
- Preleukemia
Name | Location |
|---|---|
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
