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:
Information provided by (Responsible Party):
Jane Liesveld, University of Rochester
ClinicalTrials.gov Identifier:
NCT00861874
First received: March 12, 2009
Last updated: October 8, 2012
Last verified: October 2012
  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
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:


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 ]

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

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

No publications provided by University of Rochester

Additional 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
Study First Received: March 12, 2009
Last Updated: October 8, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 19, 2014