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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


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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 23, 2015

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