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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00861874
First Posted: March 16, 2009
Last Update Posted: October 10, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jane Liesveld, University of Rochester
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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:


Further study details as provided by Jane Liesveld, 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 ]

Enrollment: 13
Study Start Date: January 2010
Primary Completion Date: September 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00861874


Locations
United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Jane Liesveld, MD University of Rochester
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Submitted: March 12, 2009
First Posted: March 16, 2009
Last Update Posted: October 10, 2012
Last Verified: October 2012

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Decitabine
Azacitidine
Sirolimus
Everolimus
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs