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

NCT00861874 | Completed Phase 1 DMC

• 1 other identifier: 26037
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Study Arms (1)

Treatment

EXPERIMENTAL

Drug: Decitabine; Drug: Rapamycin

Interventions

Decitabine DRUG

20 mg/m2 IV, Days 1-5

Treatment

Rapamycin DRUG

Dose level 1 = 2mg/daily, Dose level 2 = 4mg/daily, Dose level 3 = 6mg/daily. Oral, Days 6-26

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

Related Publications (1)

• Liesveld JL, O'Dwyer K, Walker A, Becker MW, Ifthikharuddin JJ, Mulford D, Chen R, Bechelli J, Rosell K, Minhajuddin M, Jordan CT, Phillips GL 2nd. A phase I study of decitabine and rapamycin in relapsed/refractory AML. Leuk Res. 2013 Dec;37(12):1622-7. doi: 10.1016/j.leukres.2013.09.002. Epub 2013 Sep 8.

  PMID: 24138944 DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Decitabine; Sirolimus

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Macrolides; Lactones

Study Officials

• Jane Liesveld, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Hematology and Bone Marrow Transplant

Study Record Dates

• First Submitted: March 12, 2009
• First Posted: March 16, 2009
• Study Start: January 1, 2010
• Primary Completion: September 1, 2012
• Last Updated: October 10, 2012

Record last verified: 2012-10

Locations

US (1)