Status:
COMPLETED
Sirolimus in Combination With MEC in High Risk Myeloid Leukemias
Lead Sponsor:
Abramson Cancer Center at Penn Medicine
Conditions:
Myeloid Leukemias
AML
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00780104
Start Date
July 1 2007
End Date
June 1 2010
Last Update
July 12 2019
Active Locations (1)
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1
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104