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A Prospective Single Institution Pilot Study Evaluating the Pharmacokinetics of Sirolimus in Combination With MEC (Mitoxantrone + Etoposide + Cytarabine) in Patients With High Risk Leukemias


Phase 1
18 Years
N/A
Not Enrolling
Both
Myeloid Leukemias, AML, Leukemia, CML

Thank you

Trial Information

A Prospective Single Institution Pilot Study Evaluating the Pharmacokinetics of Sirolimus in Combination With MEC (Mitoxantrone + Etoposide + Cytarabine) in Patients With High Risk Leukemias


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Assessment of biologic effects of rapamycin on mTOR targets such as p70 protein phosphorylation in leukemic cells

Outcome Time Frame:

Study conclusion

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

UPCC 02407

NCT ID:

NCT00780104

Start Date:

July 2007

Completion Date:

June 2010

Related Keywords:

  • Myeloid Leukemias
  • AML
  • Leukemia
  • CML
  • Advanced myeloid leukemias
  • AML
  • Leukemia
  • Relapsed myeloid leukemias
  • Refractory myeloid leukemias
  • MEC
  • Rapamycin
  • Sirolimus
  • Leukemia
  • Leukemia, Myeloid

Name

Location

University of Pennsylvania Abramson Cancer CenterPhiladelphia, Pennsylvania  19104