Expired Study
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Boston, Massachusetts 02115


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.


Study summary:

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.


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.


NCT ID:

NCT00136461


Primary Contact:

Principal Investigator
Richard M. Stone, MD
Dana-Farber Cancer Institute


Backup Contact:

N/A


Location Contact:

Boston, Massachusetts 02115
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 18, 2017

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