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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)


Phase 2
18 Years
N/A
Not Enrolling
Both
Acute Myelogenous Leukemia, Myelodysplastic Syndrome

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Trial Information

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)


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Principal Investigator

Richard M. Stone, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

96-278

NCT ID:

NCT00136461

Start Date:

May 1997

Completion Date:

August 2000

Related Keywords:

  • Acute Myelogenous Leukemia
  • Myelodysplastic Syndrome
  • AML
  • acute myelogenous leukemia
  • MDS
  • myelodysplastic syndrome
  • bryostatin 1
  • all-trans retinoic acid
  • ATRA
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

Dana-Farber Cancer InstituteBoston, Massachusetts  02115