Dose Escalation Phase I/II Study of Lovastatin With High-Dose Cytarabine for Refractory or Relapsed AML
The purpose of this study is to test the safety and effectiveness of combining a drug known as Lovastatin to the chemotherapy drug cytarabine. Lovastatin is currently used to lower blood cholesterol levels and lab data suggests that it increases the anti-leukemia activity of cytarabine. This research is being done because high doses of cytarabine induce remissions in only about 25% of patients with acute myeloid leukemia.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Dose Escalation Phase I/II Study of Lovastatin With High-Dose Cytarabine for Patients With Refractory or Relapsed Acute Myeloid Leukemia|
- Complete remission rate [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||June 2001|
|Estimated Study Completion Date:||June 2021|
|Estimated Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
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.
Drug: Lovastatin and Cytarabine
Cytarabine dosage: 3.0 g/m2 IV over 3 hours every 12 hours on days 3-7. 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.
|Contact: Raymond Hohl, MDemail@example.com|
|Contact: Karen Parrott, RNfirstname.lastname@example.org|
|United States, Iowa|
|Holden Comprehensive Cancer Center||Recruiting|
|Iowa City, Iowa, United States, 52242|
|Contact: Raymond Hohl, MD 319-356-8110 email@example.com|
|Contact: Karen Parrott, RN 319-353-6347 firstname.lastname@example.org|
|Principal Investigator:||Raymond Hohl, MD||University of Iowa|