S0301 Cyclosporine, Daunorubicin, and Cytarabine in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia
- Conditions
- Leukemia
- Registration Number
- NCT00066794
- Lead Sponsor
- SWOG Cancer Research Network
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as cyclosporine, daunorubicin, and cytarabine, use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving cyclosporine together with daunorubicin and cytarabine works in treating older patients with untreated acute myeloid leukemia.
- Detailed Description
OBJECTIVES:
* Determine the safety and efficacy of cyclosporine, daunorubicin, and cytarabine in older patients with previously untreated acute myeloid leukemia.
* Determine the frequency and severity of toxic effects of this regimen in these patients.
* Determine, preliminarily, the frequency and prognostic significance of functional and phenotypic P-glycoprotein expression and cytogenetics in patients treated with this regimen.
* Determine, preliminarily, the pharmacokinetic characteristics of this regimen in these patients.
OUTLINE: This is a multicenter study.
* Induction therapy: Patients receive cyclosporine IV and daunorubicin IV continuously on days 1-3 and cytarabine IV continuously on days 1-7. Patients who achieve complete response (CR) after chemotherapy receive filgrastim (G-CSF) or sargramostim (GM-CSF) IV or subcutaneously beginning on day 15 or 20 and continuing until blood counts recover. Patients who maintain CR after 2 courses of induction therapy proceed to consolidation therapy.
* Consolidation therapy: Patients receive treatment as in induction therapy with cyclosporine and daunorubicin on days 1-2 and cytarabine on days 1-5. Patients achieving CR receive an additional course of chemotherapy beginning at least 14 days after completion of the first course of cytarabine.
Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for 3 years.
PROJECTED ACCRUAL: A total of 25-64 patients will be accrued for this study within 13 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 69
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Complete remission (CR) After induction therapy is completed
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (97)
Mobile Infirmary Medical Center
🇺🇸Mobile, Alabama, United States
Arizona Cancer Center at University of Arizona Health Sciences Center
🇺🇸Tucson, Arizona, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
🇺🇸Orange, California, United States
Mercy Regional Cancer Center at Mercy Medical Center
🇺🇸Redding, California, United States
St. Luke's Mountain States Tumor Institute - Boise
🇺🇸Boise, Idaho, United States
Saint Anthony's Hospital at Saint Anthony's Health Center
🇺🇸Alton, Illinois, United States
Good Samaritan Regional Health Center
🇺🇸Mt. Vernon, Illinois, United States
Cancer Center of Kansas, PA - Chanute
🇺🇸Chanute, Kansas, United States
Cancer Center of Kansas, PA - Dodge City
🇺🇸Dodge City, Kansas, United States
Cancer Center of Kansas, PA - El Dorado
🇺🇸El Dorado, Kansas, United States
Scroll for more (87 remaining)Mobile Infirmary Medical Center🇺🇸Mobile, Alabama, United States