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

This study is currently recruiting participants.

Verified September 2011 by University of Rochester

First Received on March 12, 2009. Last Updated on September 23, 2011 History of Changes

Sponsor:	University of Rochester
Information provided by (Responsible Party):	Jane Liesveld, University of Rochester
ClinicalTrials.gov Identifier:	NCT00861874

Purpose

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.

Condition	Intervention	Phase
Acute Myeloid Leukemia	Drug: Decitabine Drug: Rapamycin	Phase I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase I Study of Decitabine in Combination With Escalating Doses of Rapamycin in Patients With Relapsed or Refractory Acute Myeloid Leukemia

Resource links provided by NLM:

MedlinePlus related topics: Acute Myeloid Leukemia Leukemia

Drug Information available for: Sirolimus Everolimus CCI 779 5-Aza-2'-deoxycytidine

U.S. FDA Resources

Further study details as provided by University of Rochester:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	16
Study Start Date:	January 2010
Estimated Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Treatment	Drug: Decitabine 20 mg/m2 IV, Days 1-5 Drug: Rapamycin Dose level 1 = 2mg/daily, Dose level 2 = 4mg/daily, Dose level 3 = 6mg/daily. Oral, Days 6-26

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00861874

Contacts

Contact: Jane Liesveld, MD

585-275-4099

Jane_Liesveld@urmc.rochester.edu

Locations

United States, New York
University of Rochester	Recruiting
Rochester, New York, United States, 14642
Contact: Jane Liesveld, MD 585-275-4099 Jane_Liesveld@urmc.rochester.edu

Sponsors and Collaborators

University of Rochester

Investigators

Principal Investigator:

Jane Liesveld, MD

University of Rochester

More Information

No publications provided

Responsible Party:	Jane Liesveld, Professor of Medicine, Hematology and Bone Marrow Transplant, University of Rochester
ClinicalTrials.gov Identifier:	NCT00861874 History of Changes
Other Study ID Numbers:	26037
Study First Received:	March 12, 2009
Last Updated:	September 23, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Decitabine
Sirolimus
Everolimus
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Antibiotics, Antineoplastic
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on February 09, 2012