Sirolimus in Combination With MEC in High Risk Myeloid Leukemias
Completed · Phase 1
Conditions studied: Myeloid Leukemias, AML, Leukemia, CML
In brief
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.
Key facts
- Study ID
- NCT00780104
- Run by
- Abramson Cancer Center at Penn Medicine
- People needed
- 16
- Starts
- 2007-07-01
- Expected to finish
- 2010-06-01
- Last updated by the study team
- 2019-07-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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%
You may not qualify if…
- 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
Where it is running
- University of Pennsylvania Abramson Cancer Center — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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