Sirolimus in Combination With MEC in High Risk Myeloid Leukemias

NCT ID: NCT00780104

Last Updated: 2019-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2010-06-30

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.

Conditions

Myeloid Leukemias; AML; Leukemia; CML

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rapamycin + MEC

Group Type: EXPERIMENTAL

Rapamycin, Mitoxantrone, Etoposide, Cytarabine

Intervention Type: DRUG

Rapamycin loading dose of 12 mg followed by a single daily dose for 8 days of 4 mg/day + MEC (Mitoxantrone 8 mg/m2/day IV, Etoposide 100 mg/m2/day IV and Cytarabine 1000 mg/m2 IV every 24 hours for 5 days. Starts after 4th dose of sirolimus.

Rapamycin + MEC

Intervention Type: DRUG

Rapamycin loading dose of 12 mg followed by a single daily dose for 8 days of 4 mg/day + MEC (Mitoxantrone 8 mg/m2/day IV, Etoposide 100 mg/m2/day IV and Cytarabine 1000 mg/m2 IV every 24 hours for 5 days. Starts after 4th dose of sirolimus.

Interventions

Rapamycin, Mitoxantrone, Etoposide, Cytarabine

Rapamycin loading dose of 12 mg followed by a single daily dose for 8 days of 4 mg/day + MEC (Mitoxantrone 8 mg/m2/day IV, Etoposide 100 mg/m2/day IV and Cytarabine 1000 mg/m2 IV every 24 hours for 5 days. Starts after 4th dose of sirolimus.

Intervention Type: DRUG

Rapamycin + MEC

Rapamycin loading dose of 12 mg followed by a single daily dose for 8 days of 4 mg/day + MEC (Mitoxantrone 8 mg/m2/day IV, Etoposide 100 mg/m2/day IV and Cytarabine 1000 mg/m2 IV every 24 hours for 5 days. Starts after 4th dose of sirolimus.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Pennsylvania Abramson Cancer Center

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

UPCC 02407

Identifier Type: -

Identifier Source: org_study_id