A Phase I Study of Decitabine in Combination With Escalating Doses of Rapamycin in Patients With Relapsed or Refractory Acute Myeloid Leukemia

University of Rochester1 site in 1 country13 target enrollmentJanuary 2010

ConditionsAcute Myeloid Leukemia

InterventionsDecitabine Rapamycin

DrugsDecitabine Rapamycin

Overview

Phase: Phase 1
Intervention: Decitabine
Conditions: Acute Myeloid Leukemia
Sponsor: University of Rochester
Enrollment: 13
Locations: 1
Primary Endpoint: Evaluate the safety of chemotherapy with the drug decitabine combined with rapamycin to determine the highest dose of rapamycin that can be given in combination with decitabine.
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine the safety and feasibility of the combination of decitabine given at a fixed dose with escalating doses of rapamycin in patients with relapsed or refractory acute myeloid leukemia.

Registry

clinicaltrials.gov

Start Date

January 2010

End Date

September 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Rochester

Responsible Party

Principal Investigator

Jane Liesveld

Professor of Medicine, Hematology and Bone Marrow Transplant

University of Rochester

Eligibility Criteria

Inclusion Criteria

•Age greater than or equal to 18 years
•Diagnosis of AML according to WHO criteria except acute promyelocytic leukemia AND
•Refractory AML defined as a failure to achieve CR after 2 cycles of induction chemotherapy or persistence of \> 40% bone marrow blasts after one cycle of chemotherapy induction OR
•Relapsed AML defined as any evidence of disease recurrence within 12 months of achieving first CR OR
•Relapsed AML after stem cell transplantation 100 days must have elapsed between transplant and emergence of recurrent AML
•ECOG performance status \<3 (Appendix 1)

Exclusion Criteria

•Abnormal renal function as evidenced by a calculated creatinine clearance ≤ 30ml/min (Cockcroft-Gault formula (Appendix 2)
•Abnormal liver function: Bilirubin \>2.0 mg/dl, transaminase more than 2.5x the upper limits of normal
•Active systemic infection
•Known chronic liver disease
•Known diagnosis of human immunodeficiency virus infection (HIV)
•Patients who are post-allogeneic transplantation should not have active GVHD greater than grade 1 of skin
•Pregnant or breast feeding female subjects

Arms & Interventions

Treatment

Intervention: Decitabine

Treatment

Intervention: Rapamycin

Outcomes

Primary Outcomes

Evaluate the safety of chemotherapy with the drug decitabine combined with rapamycin to determine the highest dose of rapamycin that can be given in combination with decitabine.

Time Frame: 6 months