Status:
COMPLETED
Pilot Trial of Sirolimus/MEC in High Risk Acute Myelogenous Leukemia (AML)
Lead Sponsor:
Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborating Sponsors:
University of Pennsylvania
Conditions:
AML
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the addition of Sirolimus (rapamycin) to standard chemotherapy for the treatment of patients with high risk acute myelogenous leukemia (AML). Cancer cells take...
Detailed Description
Recent improvements in our understanding of leukemia biology have led to the introduction of highly effective, molecularly targeted therapies. This is exemplified by the development of BCR-ABL tyrosin...
Eligibility Criteria
Inclusion
- Patients must have histologic evidence of high risk acute myeloid leukemia defined as one of the following:
- Primary refractory non-M3 AML (i) Residual leukemia after a minimum of 2 prior courses of chemotherapy (Same or different) (ii) Evidence of leukemia after a nadir bone marrow biopsy demonstrates no evidence of residual leukemia.
- Relapsed non-M3 AML
- Any non-M3 AML age \>60 with no evidence of favorable karyotype (stratum 2 ONLY), defined by presence of t(8;21)(q22;q22) \[AML1-ETO\], inv16(p13;q22), or t(16;16)(p13;q22) \[CBF;MYH11\] by cytogenetics, FISH, or RT-PCR
- Secondary AML (from antecedent hematologic malignancy or following therapy with radiation or chemotherapy for another disease) with no evidence of favorable karyotype (stratum 2 ONLY), defined by presence of t(8;21)(q22;q22) \[AML1-ETO\], inv16(p13;q22), or t(16;16)(p13;q22) \[CBF;MYH11\] by cytogenetics, FISH, or RT-PCR
- Age \> or = 18
- ECOG = 0 or 1
Exclusion
- Subjects with FAB M3 (t(15;17)(q22;q21)\[PML-RAR\]) are not eligible
- Subjects taking the following are not eligible:
- Carbamazepine (e.g., Tegretol)
- Rifabutin (e.g., Mycobutin) or
- Rifampin (e.g., Rifadin)
- Rifapentine (e.g., Priftin)
- St. John's wort
- Clarithromycin (e.g., Biaxin)
- Cyclosporine (e.g. Neoral or Sandimmune)
- Diltiazem (e.g., Cardizem)
- Erythromycin (e.g., Akne-Mycin, Ery-Tab)
- Itraconazole (e.g., Sporanox)
- Ketoconazole (e.g., Nizoral)
- Telithromycin (e.g., Ketek)
- Verapamil (e.g., Calan SR, Isoptin, Verelan)
- Voriconazole (e.g., VFEND)
- Tacrolimus (e.g. Prograf)
- Subjects taking fluconazole, voriconazole, itraconazole, posaconazole, and ketoconazole within 72 hours of study entry are not eligible. Reinstitution of fluconazole, voriconazole, itraconazole, posaconazole, ketoconazole and diltiazem is permissible 72 hours after the last dose of sirolimus.
- Subjects must not be receiving any chemotherapy agents (except Hydroxyurea). Intrathecal methotrexate and cytarabine are permissible
- Subjects must not be receiving growth factors, except for erythropoietin
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01184898
Start Date
July 1 2010
End Date
February 1 2016
Last Update
May 31 2025
Active Locations (2)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
2
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107