Spots Global Cancer Trial Database for Clofarabine and Temsirolimus in Treating Older Patients With Relapsed or Refractory Acute Myeloid Leukemia
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Trial Identification
Brief Title: Clofarabine and Temsirolimus in Treating Older Patients With Relapsed or Refractory Acute Myeloid Leukemia
Official Title: An Open Label Phase II Trial of Clofarabine and Temsirolimus in Older Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)
Study ID: NCT00775593
Conditions
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as clofarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Temsirolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving clofarabine together with temsirolimus may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving clofarabine together with temsirolimus works in treating older patients with relapsed or refractory acute myeloid leukemia.
Detailed Description: OBJECTIVES: Primary * To determine the complete response rate in older patients with relapsed or refractory acute myeloid leukemia when treated with low-dose clofarabine and temsirolimus. Secondary * To determine the tolerability and safety of this regimen. * To determine the duration of response. * To determine the duration of survival. OUTLINE: This is a multicenter study. * Induction therapy: Patients receive clofarabine IV over 1 hour on days 1-5 and temsirolimus IV over 30 minutes on days 1, 8, and 15. Treatment continues for 1-2 courses in the absence of disease progression or unacceptable toxicity. * Maintenance therapy: Patients achieving morphologic complete remission (CR) or CR with incomplete blood count recovery receive temsirolimus IV over 30 minutes on days 1 and 8 of each month. Treatment continues for 12 months in the absence of disease progression or unacceptable toxicity.
Keywords
Eligibility
Minimum Age: 60 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Azienda ospedaliera Nuovo ospedale "Torrette", Ancona, , Italy
Azienda Ospedaliero-Universitaria Policlinico Consorziale, Bari, , Italy
Azienda Ospedaliera Di Bologna Policlinico S. Orsola - Malpighi, Bologna, , Italy
Ospedale Ferrarotto, Catania, , Italy
Ospedale Regionale A. Pugliese, Catanzaro, , Italy
Azienda ospedaliera di Rilievo Nazionale "A. Cardarelli", Napoli, , Italy
Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia, Napoli, , Italy
S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro, Novara, , Italy
A.O. Universitaria S. Luigi Gonzaga di Orbassano, Orbassano, , Italy
Azienda Ospedaliero - Universitaria di Parma, Parma, , Italy
Azienda ASL di Pescara, Pescara, , Italy
Complesso Ospedaliero S. Giovanni Addolorata, Roma, , Italy
Ospedale S. Eugenio, Roma, , Italy
S.C. di Ematologia e Trapianti - I.F.O. Istituto Nazionale Tumori Regina Elena, Roma, , Italy
Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia, Roma, , Italy
Policlinico di Tor Vergata, Rome, , Italy
Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore, Rome, , Italy
Serv. di Ematologia Ist. di Ematologia ed Endocrinologia, Sassari, , Italy
Policlinico G. B. Rossi - Borgo Roma, Verona, , Italy
Contact Details
Name: Sergio Amadori, MD
Affiliation: Ospedale Sant' Eugenio
Role: PRINCIPAL_INVESTIGATOR
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