The Clinical Application of Tumor Reversion: A Phase I study of sertraline (Zoloft) in combination with timed-sequential cytosine arabinoside (ara-C) in adults with relapsed and refractory acute myeloid leukemia (AML)

Protocol: 
AAAQ8444
Phase: 
I

The Clinical Application of Tumor Reversion: A Phase I study of sertraline (Zoloft) in combination with timed-sequential cytosine arabinoside (ara-C) in adults with relapsed and refractory acute myeloid leukemia (AML)

The purpose of the study is to evaluate the safety, tolerability (the effect of the drug on your body), pharmacokinetics (the effect of your body on the drug) and maximum tolerated dose of sertraline in combination with cytosine arabinoside (ara-C, cytarabine) when given to patients with treatment-resistant myeloid leukemia. In addition, the effect of the drug on your cancer and so-called biomarkers (markers of biological activities in your body), will be determined in blood and bone marrow. Another purpose of the study is what effects (both good and bad) it has on you and your cancer.

Are you Eligible? (Inclusion Criteria)

1) Pathologically-confirmed diagnoses of relapsed AML: Patients with AML that have relapsed at
least once or are primary induction failure will be eligible.
2) Age >=18 and <=70 years
3) Patients who have undergone stem cell transplantation (SCT), autologous or allogeneic, are
eligible provided that they are >8 weeks from stem cell infusion, have no active GVHD, are off
immune suppression for at least 2 weeks, and do not have a history of VOD.

Specialty Area(s)

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States