Sirolimus in Combination With MEC in High Risk Myeloid Leukemias (UPCC 02407)

Abramson Cancer Center at Penn Medicine

Status and phase: Completed; Phase 1

Conditions: AML; Myeloid Leukemias; CML; Leukemia

Treatments: Drug: Rapamycin, Mitoxantrone, Etoposide, Cytarabine; Drug: Rapamycin + MEC

Study type: Interventional

Funder types: Other

Identifiers

NCT00780104

UPCC 02407

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Rapamycin + MEC

Experimental group

Treatment:

Drug: Rapamycin + MEC

Drug: Rapamycin, Mitoxantrone, Etoposide, Cytarabine