Sirolimus in Combination With MEC in High Risk Myeloid Leukemias

A Prospective Single Institution Pilot Study Evaluating the Pharmacokinetics of Sirolimus in Combination With MEC (Mitoxantrone + Etoposide + Cytarabine) in Patients With High Risk Leukemias

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00780104

Acronym

UPCC 02407

Enrollment

Registered

2008-10-27

Start date

2007-07-31

Completion date

2010-06-30

Last updated

2019-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AML, CML, Leukemia, Myeloid Leukemias

Keywords

Advanced myeloid leukemias, AML, Leukemia, Relapsed myeloid leukemias, Refractory myeloid leukemias, MEC, Rapamycin, Sirolimus

Brief summary

The purpose of this study is to evaluate the side effects of sirolimus (rapamycin) given in combination with chemotherapy (Mitoxantrone + Etoposide + Cytarabine (MEC)) on high risk myeloid leukemias.

Interventions

DRUGRapamycin, Mitoxantrone, Etoposide, Cytarabine

Rapamycin loading dose of 12 mg followed by a single daily dose for 8 days of 4 mg/day + MEC (Mitoxantrone 8 mg/m2/day IV, Etoposide 100 mg/m2/day IV and Cytarabine 1000 mg/m2 IV every 24 hours for 5 days. Starts after 4th dose of sirolimus.

DRUGRapamycin + MEC

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Must have histologic evidence of advanced myeloid leukemias defined as one of the following: primary refractory non-M3 AML; relapsed non-M3 AML; secondary AML; intermediate or poor prognosis de novo AML in patients who are \>= 60 years old * \>= 18 years of age * ECOG performance status of 0, 1 * Able to consume oral medication * Initial laboratory values: creatinine \<= 2.0 mg/dL; total or direct bilirubin \<= 1.5/dL; SGPT(ALT) \<= 3xULN; negative pregnancy test for women with child-bearing potential * Ejection fraction of \>= 45%

Exclusion criteria

* Subjects with FAM B3 * Must not be receiving chemotherapy (except Hydroxyurea) * Not receiving growth factors, except for erythropoietin * Subjects with a currently active second malignancy other than non-melanoma skin cancers * Subjects with uncontrolled high blood pressure, unstable angina, symptomatic congestive heart failure, MI within the last 6 months or uncontrolled cardiac arrhythmia * Subjects taking diltiazem * Subjects who require HIV protease inhibitors or those with AIDS-related illnesses * No evidence of cerebellar dysfunction at baseline or during prior cytarabine therapy * Not pregnant or breastfeeding * Uncontrolled infection * Subjects taking Carbamazepine, Rifabutin, Rifampin, Rifapentine, St. John's wort, Clarithromycin, Cyclosporine, Diltiazem, Erythromycin, Telithromycin, Verapamil, Tacrolimus

Design outcomes

Primary

Measure	Time frame
Assessment of biologic effects of rapamycin on mTOR targets such as p70 protein phosphorylation in leukemic cells	Study conclusion

Secondary

Measure	Time frame
Safety of the sirolimus + MEC regimen	Study conclusion

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026