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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)

This study has been completed.
Sponsor:
Collaborator:
Brigham and Women's Hospital
Information provided by:
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00136461
First received: August 25, 2005
Last updated: March 9, 2011
Last verified: March 2011
History of Changes
  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 2

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:

Drug Information available for: 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 May 23, 2013