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:
University of Rochester
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
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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
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
| 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 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 May 22, 2013