NCT00780104CompletedPhase 1
A Prospective Single Institution Pilot Study Evaluating the Pharmacokinetics of Sirolimus in Combination With MEC (Mitoxantrone + Etoposide + Cytarabine) in Patients With High Risk Leukemias
Abramson Cancer Center at Penn Medicine1 site in 1 country16 target enrollmentStarted: July 2007Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Assessment of biologic effects of rapamycin on mTOR targets such as p70 protein phosphorylation in leukemic cells
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Rapamycin + MEC
Experimental
Intervention: Rapamycin, Mitoxantrone, Etoposide, Cytarabine (Drug)
Rapamycin + MEC
Experimental
Intervention: Rapamycin + MEC (Drug)
Outcomes
Primary Outcomes
Assessment of biologic effects of rapamycin on mTOR targets such as p70 protein phosphorylation in leukemic cells
Time Frame: Study conclusion
Secondary Outcomes
- Safety of the sirolimus + MEC regimen(Study conclusion)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
Pilot Trial of Sirolimus/MEC in High Risk Acute Myelogenous Leukemia (AML)AMLNCT01184898Sidney Kimmel Cancer Center at Thomas Jefferson University36
Completed
Phase 1
Sirolimus, Cisplatin, and Gemcitabine Hydrochloride in Treating Patients With Bladder CancerRecurrent Bladder CarcinomaStage II Bladder CancerStage III Bladder CancerStage IV Bladder CancerNCT01938573University of Washington21
Active, not recruiting
Not Applicable
A Clinical Trial to Evaluate the Safety and Efficacy of IBS in Patients With Coronary Artery DiseaseCoronary Artery DiseaseNCT05205499Biotyx Medical (Shenzhen) Co., Ltd.1,059
Completed
Phase 4
Pilot Study on the Use of Sirolimus to Treat Chronic Allograft Nephropathy in Children After Kidney TransplantKidney TransplantationNCT00188955University of Manitoba40
Terminated
Phase 2
Topical Sirolimus Ointment for Cutaneous Angiofibromas in Subjects With Tuberous Sclerosis ComplexAngiofibroma of FaceTuberous SclerosisNCT03363763Aucta Pharmaceuticals, Inc24