Sirolimus in Combination With MEC in High Risk Myeloid Leukemias

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abramson Cancer Center of the University of Pennsylvania
• Treatments: Cytarabine; Etoposide; Etoposide phosphate; Everolimus; Mitoxantrone; Sirolimus

Criteria

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