Clofarabine and Temsirolimus in Treating Older Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML1107)
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.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Label Phase II Trial of Clofarabine and Temsirolimus in Older Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)|
- Complete response rate [ Time Frame: At 2 years from study entry ] [ Designated as safety issue: No ]
- Tolerability and safety [ Time Frame: At 2 years from study entry ] [ Designated as safety issue: Yes ]
- Duration of response [ Time Frame: At 2 years from study entry ] [ Designated as safety issue: No ]
- Duration of survival [ Time Frame: At 2 years from study entry ] [ Designated as safety issue: No ]
|Study Start Date:||December 2008|
|Estimated Study Completion Date:||June 2012|
|Estimated Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Patients will receive one course of low-dose Clofarabine in combination with Temsirolimus (CloTor regimen) for remission induction.
- Clofarabine 20 mg/m2/day, administered by iv infusion over 1 hour on days 1 through 5
Those who achieve morphologic CR and morphologic CRi will receive maintenance treatment with Temsirolimus monthly for 12 months, or until relapse.
Those who achieve a PR will receive one additional course of CloTor and, if a CR/CRi is obtained, maintenance treatment with Temsirolimus as above.
- Temsirolimus 25 mg (flat dose) administered iv over 30 minutes on days 1, 8 and 15.
- Temsirolimus 25 mg (flat dose) administered iv over 30 minutes on days 1 and 8 of each month for 12 months, or until relapse.
- To determine the complete response rate in older patients with relapsed or refractory acute myeloid leukemia when treated with low-dose clofarabine and temsirolimus.
- 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.
|Azienda ospedaliera Nuovo ospedale "Torrette"|
|Azienda Ospedaliero-Universitaria Policlinico Consorziale|
|Azienda Ospedaliera Di Bologna Policlinico S. Orsola - Malpighi|
|Bologna, Italy, 40138|
|Catania, Italy, 95124|
|Ospedale Regionale A. Pugliese|
|Catanzaro, Italy, 88100|
|Azienda ospedaliera di Rilievo Nazionale "A. Cardarelli"|
|Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia|
|S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro|
|A.O. Universitaria S. Luigi Gonzaga di Orbassano|
|Azienda Ospedaliero - Universitaria di Parma|
|Azienda ASL di Pescara|
|Pescara, Italy, 61100|
|Complesso Ospedaliero S. Giovanni Addolorata|
|S.C. di Ematologia e Trapianti - I.F.O. Istituto Nazionale Tumori Regina Elena|
|Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia|
|Ospedale S. Eugenio|
|Policlinico di Tor Vergata|
|Rome, Italy, 00133|
|Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore|
|Rome, Italy, 00168|
|Serv. di Ematologia Ist. di Ematologia ed Endocrinologia|
|Policlinico G. B. Rossi - Borgo Roma|
|Verona, Italy, 37134|
|Principal Investigator:||Sergio Amadori, MD||Ospedale Sant' Eugenio|