A Study of All-Trans Retinoic Acid (ATRA) and Bryostatin in Patients With Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)
Information source: Dana-Farber Cancer Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Myelogenous Leukemia; Myelodysplastic Syndrome
Intervention: All-trans retinoic acid (Drug); Bryostatin 1 (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Dana-Farber Cancer Institute Official(s) and/or principal investigator(s):
Richard M. Stone, MD, Principal Investigator, Affiliation: Dana-Farber Cancer Institute
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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: 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.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Dana-Farber Cancer Institute, Boston, Massachusetts 02115, United States
Additional Information
Starting date: May 1997
Last updated: March 9, 2011
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