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

Sponsor:	Dana-Farber Cancer Institute
Collaborator:	Brigham and Women's Hospital
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00136461

Purpose

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	Intervention	Phase
Acute Myelogenous Leukemia Myelodysplastic Syndrome	Drug: All-trans retinoic acid Drug: Bryostatin 1	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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)

Resource links provided by NLM:

MedlinePlus related topics: Acute Myeloid Leukemia Cancer Leukemia Myelodysplastic Syndromes

Drug Information available for: Bryostatin 1 Tretinoin

U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

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:

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.

Estimated Enrollment:	40
Study Start Date:	May 1997
Study Completion Date:	August 2000
Primary Completion Date:	August 2000 (Final data collection date for primary outcome measure)

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00136461

Locations

United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Dana-Farber Cancer Institute

Brigham and Women's Hospital

Investigators

Principal Investigator:

Richard M. Stone, MD

Dana-Farber Cancer Institute

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00136461 History of Changes
Other Study ID Numbers:	96-278, NCI# T96-0112
Study First Received:	August 25, 2005
Last Updated:	March 9, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:

AML
acute myelogenous leukemia
MDS
myelodysplastic syndrome

bryostatin 1
all-trans retinoic acid
ATRA

Additional relevant MeSH terms:

Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Myelodysplastic Syndromes
Preleukemia
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions

Bryostatin 1
Tretinoin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Keratolytic Agents
Dermatologic Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012