Sirolimus in Combination With MEC in High Risk Myeloid Leukemias

Phase 1

Completed

• Conditions: AML; Myeloid Leukemias; Leukemia; CML
• Interventions: Drug: Rapamycin, Mitoxantrone, Etoposide, Cytarabine; Drug: Rapamycin + MEC

• Registration Number: NCT00780104
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2008-10-24
• Study First Submitted QC: 2008-10-24
• Study First Posted: 2008-10-27
• Primary Completion: 2010-01
• Study Completion: 2010-06
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-10
• Last Update Posted: 2019-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rapamycin + MEC	Rapamycin, Mitoxantrone, Etoposide, Cytarabine	-
Rapamycin + MEC	Rapamycin + MEC	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Safety of the sirolimus + MEC regimen	Study conclusion

Trial Locations

Locations (1)

University of Pennsylvania Abramson Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States