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Clinical Trial SWOG 1203

Title
A Randomized Phase III Study of Standard Cytarabine plus Daunorubicin (7+3) Therapy or Idarubicin with High Dose Cytarabine (IA) versus IA with Vorinostat (IA+V) in Younger Patients with Previously Untreated Acute Myeloid Leukemia (AML)
Principal Investigator
Jessica Altman
Details
  • Status: Accepting New Patients
  • Study Type: Therapeutic, Treatment
  • Protocol No:.SWOG 1203
Purpose
The purpose of this study is to compare the effects, good and/or bad of three drug combinations on patients and their cancer. The combinations are: 1) daunorubicin plus AraC (called “7+3” treatment), 2) idarubicin plus AraC (called “IA” treatment), and 3) vorinostat added to IA therapy.
Overview
This study is for patients who have acute myeloid leukemia (AML). In this study three different drug combinations will be compared. The first two combinations are standard treatment for AML. These are daunorubicin plus AraC (“7+3”) and idarubicin plus AraC (“IA”). Both of these treatments have been approved for AML. The third combination will add the drug vorinostat to the standard IA therapy. Vorinostat is approved for other types of cancer, but has not been approved for AML, so it is considered investigational for this study. For patients who may benefit from a stem cell transplant, the study doctor also want to see if we can find stem cell transplant donors for patients.
Eligibility
Some of the eligibility criteria include:
  • Participants must be newly diagnosed AML.
  • Participants may have not received prior chemotherapy for their AML.
  • Participants must be 18-60 years of age.
Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Description of Treatment
Study participants will be assigned to one of three treatment groups. In all three groups participants will have three phases of treatment: induction, consolidation and transplant. Participants in Group 1 will get 7+3 induction, then consolidation with AraC alone. Participants in Group two will get IA for both induction and consolidation. Participants in Group 3 will get IA + vorinostat for induction and consolidation. No matter what group participants are in for induction and consolidation, they will get a stem cell transplant if they have high-risk disease and have a donor available.
Contact
Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
312.695.1102
cancertrials@northwestern.edu

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last updated: 25-Oct-14 10:15 AM

 

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