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
  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:


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
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, see Learn About Clinical Studies.

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 August 28, 2014