COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH:
Working… Menu

A Study of All-Trans Retinoic Acid (ATRA) and Bryostatin in Patients With Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00136461
Recruitment Status : Completed
First Posted : August 29, 2005
Last Update Posted : March 10, 2011
Brigham and Women's Hospital
Information provided by:
Dana-Farber Cancer Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Myelogenous Leukemia Myelodysplastic Syndrome Drug: All-trans retinoic acid Drug: Bryostatin 1 Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 1997
Actual Primary Completion Date : August 2000
Actual Study Completion Date : August 2000

Primary Outcome Measures :
  1. 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 Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00136461

Layout table for location information
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Layout table for investigator information
Principal Investigator: Richard M. Stone, MD Dana-Farber Cancer Institute
Layout table for additonal information Identifier: NCT00136461    
Other Study ID Numbers: 96-278
NCI# T96-0112
First Posted: August 29, 2005    Key Record Dates
Last Update Posted: March 10, 2011
Last Verified: March 2011
Keywords provided by Dana-Farber Cancer Institute:
acute myelogenous leukemia
myelodysplastic syndrome
bryostatin 1
all-trans retinoic acid
Additional relevant MeSH terms:
Layout table for MeSH terms
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Pathologic Processes
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Bryostatin 1
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs