Dose Escalation Phase I/II Study of Lovastatin With High-Dose Cytarabine for Refractory or Relapsed AML
|ClinicalTrials.gov Identifier: NCT00583102|
Recruitment Status : Terminated (Slow accrual, PI left institution)
First Posted : December 31, 2007
Results First Posted : January 5, 2018
Last Update Posted : January 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia||Drug: Cytarabine Drug: Lovastatin||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Dose Escalation Phase I/II Study of Lovastatin With High-Dose Cytarabine for Patients With Refractory or Relapsed Acute Myeloid Leukemia|
|Actual Study Start Date :||June 2001|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||June 2013|
Experimental: Lovastatin followed by Cytarabine
The subject will receive high dose cytarabine as well as lovastatin. The subject will take doses of lovastatin twice a day, about 12 hours apart. On the third day, the subject will begin high-dose cytarabine IV over 3 hours, twice a day, starting 1 hour after the lovastatin dose for 5 days.
Cytarabine dosage: 3.0 g/m2 IV over 3 hours every 12 hours on days 3-7.
Other Names:Drug: Lovastatin
Lovastatin dosage: The first dose level will be lovastatin at 0.5 mg/kg/day. After each patient reaches day 14 subsequent patients will be treated at incrementally increasing doses that are 1 mg/kg/day, 2 mg/kg/day, 4 mg/kg/day, 8 mg/kg/day, 12 mg/kg/day, 18 mg/kg/day, and 24 mg/kg/day. If MTD is not reached at this dose of 24 mg/kg/day further dose escalations will occur with a 33% increase in dose at each level rounded to the nearest mg/kg/day.
- Complete Remission Rate [ Time Frame: 5 weeks ]
The primary study end point will be complete remission rate.
Complete Remission (CR):
Complete remission is defined as the presence of all of the following:
Peripheral Blood Counts (sustained > 30 days)
- Absolute neutrophil count ³1500/ml.
- Platelet count ³100,000/ml.
- No leukemic blasts in the peripheral blood.
- Transfusion independent for red cells and platelets. Bone Marrow
- Cellularity >20% with maturation of all cell lines.
- No Auer rods.
- <5% blast cells. No extramedullary leukemia (such as CNS or soft tissue involvement). OR Complete Response with Incomplete Platelet Recovery (CRp): CRp satisfies all CR criteria except platelets < 100,000/µL.
Partial Remission (PR):
Must meet all criteria of a CR except that the bone marrow may contain 5-24% blasts.
Failure to achieve a CR.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00583102
|United States, Iowa|
|Holden Comprehensive Cancer Center|
|Iowa City, Iowa, United States, 52242|
|Principal Investigator:||Raymond Hohl, MD||University of Iowa|