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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.
Study NCT00136461   Information provided by Dana-Farber Cancer Institute
First Received: August 25, 2005   Last Updated: January 6, 2009   History of Changes

August 25, 2005
January 6, 2009
May 1997
 
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.
Same as current
Complete list of historical versions of study NCT00136461 on ClinicalTrials.gov Archive Site
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.
Same as current
 
A Study of All-Trans Retinoic Acid (ATRA) and Bryostatin in Patients With Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)
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)

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.

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.

Phase II
Interventional
Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
  • Acute Myelogenous Leukemia
  • Myelodysplastic Syndrome
  • Drug: All-trans retinoic acid
  • Drug: Bryostatin 1
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
40
August 2000
 

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00136461
 
96-278, NCI# T96-0112
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Principal Investigator: Richard M. Stone, MD Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP