RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer
cells, either by killing the cells or by stopping them from dividing. Giving more than one
drug (combination chemotherapy), and giving the drugs in different combinations may kill
more cancer cells.
PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating
patients with newly diagnosed acute lymphoblastic leukemia.
- Determine the probability of 1-year continuous complete remission in patients with
newly diagnosed acute lymphoblastic leukemia treated with first induction chemotherapy
comprising daunorubicin, vincristine, prednisone, and pegaspargase; and second
induction chemotherapy comprising high-dose cytarabine and mitoxantrone.
Secondary
- Determine the frequency and severity of toxic effects of these induction regimens
followed by consolidation therapy comprising cyclophosphamide, cytarabine,
mercaptopurine, and methotrexate and maintenance chemotherapy comprising
mercaptopurine, methotrexate, vincristine, doxorubicin, dexamethasone,
cyclophosphamide, thioguanine, and cytarabine in these patients.
Other objectives (if funding allows):
- To evaluate in a preliminary manner the significance of detecting minimal residual
disease as a prognostic factor for survival and relapse-free survival of patients
receiving chemotherapy
- To evaluate in a preliminary manner the pattern of gene expression of patients entered
onto the trial and its relationship to cytogenetics/FISH risk classification, overall
survival, and relapse-free survival
OUTLINE: This is a multicenter study.
- First induction chemotherapy: Patients receive daunorubicin IV on days 1-3; vincristine
IV on days 1, 8, 15, and 22; prednisone IV or orally on days 1-28, followed by a taper
to day 35; and pegaspargase IV or subcutaneously (SC) on day 15. Patients with CNS
leukemia also receive methotrexate intrathecally (IT) or intraventricularly twice
weekly and oral leucovorin calcium four times daily for 4 doses after each
administration of methotrexate. When blasts are no longer present in the spinal fluid,
patients receive methotrexate IT or intraventricularly once weekly for 4 weeks and then
once monthly for 1 year.
Patients are reevaluated on day 28. Patients who achieve A1 bone marrow status and B1
peripheral blood status or those with resistant disease proceed to second induction therapy.
- Second induction chemotherapy: Patients receive high-dose cytarabine IV on days 1-5;
mitoxantrone IV on day 3; and filgrastim (G-CSF) SC or IV beginning on day 7 and
continuing until blood counts recover. Patients with CNS leukemia also receive
methotrexate and leucovorin calcium as in first induction chemotherapy.
Patients are reevaluated on day 28. Patients who achieve A1 bone marrow status and B1
peripheral blood status with no extramedullary disease (other than CNS involvement) proceed
to consolidation chemotherapy. Patients with resistant disease OR Philadelphia chromosome-
or BCR/ABL-positive disease are removed from the study after receiving double induction
chemotherapy.
- Consolidation chemotherapy: Patients receive cyclophosphamide IV on days 1, 15, and 29;
cytarabine IV on days 2-5 and 16-19; oral mercaptopurine on days 1-28; and methotrexate
IT or intraventricularly on days 2, 9, 16, and 23. Patients with CNS leukemia also
undergo cranial radiotherapy once daily, 5 days a week, for 2 weeks.
Patients in complete remission proceed to maintenance chemotherapy.
- Course 1: Patients receive oral mercaptopurine on days 1-63 and oral methotrexate
on days 1, 8, 15, 22, 29, 36, 43, 50, and 57. Patients proceed to course 2 after
blood counts recover.
- Course 2: Patients receive vincristine IV and doxorubicin IV on days 1, 8, 15, and
22 and oral dexamethasone on days 1-28. Patients proceed to course 3 after blood
counts recover.
- Course 3: Patients receive cyclophosphamide IV on day 1; oral thioguanine on days
1-14; and cytarabine IV on days 3-6 and 10-13. Patients proceed to course 4 after
blood counts recover.
- Course 4: Patients receive oral mercaptopurine once daily for 2 years and oral
methotrexate once weekly for 2 years.
Treatment continues in the absence of disease relapse or unacceptable toxicity.
After completion of study therapy, patients are followed every 3 months for 1 year, every 6
months for 1 year, and then annually for 3 years.
Providence Saint Joseph Medical Center - Burbank, Burbank, California 91505, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood, Illinois 60153, United States
Cancer Center of Kansas, PA - Chanute, Chanute, Kansas 66720, United States
Cancer Center of Kansas, PA - Dodge City, Dodge City, Kansas 67801, United States
Cancer Center of Kansas, PA - El Dorado, El Dorado, Kansas 67042, United States
Cancer Center of Kansas-Independence, Independence, Kansas 67301, United States
Cancer Center of Kansas, PA - Kingman, Kingman, Kansas 67068, United States
Lawrence Memorial Hospital, Lawrence, Kansas 66044, United States
Southwest Medical Center, Liberal, Kansas 67901, United States
Cancer Center of Kansas, PA - Newton, Newton, Kansas 67114, United States
Menorah Medical Center, Overland Park, Kansas 66209, United States
Cancer Center of Kansas, PA - Parsons, Parsons, Kansas 67357, United States
Cancer Center of Kansas, PA - Pratt, Pratt, Kansas 67124, United States
Cancer Center of Kansas, PA - Salina, Salina, Kansas 67042, United States
Shawnee Mission Medical Center, Shawnee Mission, Kansas 66204, United States
Cancer Center of Kansas, PA - Wellington, Wellington, Kansas 67152, United States
Associates in Womens Health, PA - North Review, Wichita, Kansas 67208, United States
Cancer Center of Kansas, PA - Medical Arts Tower, Wichita, Kansas 67208, United States
Cancer Center of Kansas, PA - Wichita, Wichita, Kansas 67214, United States
CCOP - Wichita, Wichita, Kansas 67214, United States
Via Christi Cancer Center at Via Christi Regional Medical Center, Wichita, Kansas 67214, United States
Wesley Medical Center, Wichita, Kansas 67214, United States
Cancer Center of Kansas, PA - Winfield, Winfield, Kansas 67156, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan 48109-0942, United States
Josephine Ford Cancer Center at Henry Ford Hospital, Detroit, Michigan 48202, United States
Independence Regional Health Center, Independence, Missouri 64050, United States
CCOP - Kansas City, Kansas City, Missouri 64131, United States
North Kansas City Hospital, Kansas City, Missouri 64116, United States
Parvin Radiation Oncology, Kansas City, Missouri 64116, United States
Research Medical Center, Kansas City, Missouri 64132, United States
Saint Luke's Cancer Institute at Saint Luke's Hospital, Kansas City, Missouri 64111, United States
St. Joseph Medical Center, Kansas City, Missouri 64114, United States
Truman Medical Center - Hospital Hill, Kansas City, Missouri 64108, United States
Saint Luke's East - Lee's Summit, Lee's Summit, Missouri 64086, United States
Liberty Hospital, Liberty, Missouri 64068, United States
Heartland Regional Medical Center, Saint Joseph, Missouri 64506, United States
Billings Clinic - Downtown, Billings, Montana 59107-7000, United States
CCOP - Montana Cancer Consortium, Billings, Montana 59101, United States
Hematology-Oncology Centers of the Northern Rockies - Billings, Billings, Montana 59101, United States
Northern Rockies Radiation Oncology Center, Billings, Montana 59101, United States
St. Vincent Healthcare Cancer Care Services, Billings, Montana 59101, United States
Bozeman Deaconess Cancer Center, Bozeman, Montana 59715, United States
St. James Healthcare Cancer Care, Butte, Montana 59701, United States
Big Sky Oncology, Great Falls, Montana 59405-5309, United States
Frontier Cancer Center, Great Falls, Montana 59405, United States
Great Falls Clinic - Main Facility, Great Falls, Montana 59405, United States
Sletten Cancer Institute at Benefis Healthcare, Great Falls, Montana 59405, United States
Northern Montana Hospital, Havre, Montana 59501, United States
St. Peter's Hospital, Helena, Montana 59601, United States
Glacier Oncology, PLLC, Kalispell, Montana 59901, United States
Kalispell Medical Oncology at KRMC, Kalispell, Montana 59901, United States
Kalispell Regional Medical Center, Kalispell, Montana 59901, United States
Community Medical Center, Missoula, Montana 59801, United States
Guardian Oncology and Center for Wellness, Missoula, Montana 59804, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center, Missoula, Montana 59807, United States
Montana Cancer Specialists at Montana Cancer Center, Missoula, Montana 59807-7877, United States
Wayne Memorial Hospital, Incorporated, Goldsboro, North Carolina 27534, United States
Rutherford Hospital, Rutherfordton, North Carolina 28139, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio 44195, United States
AnMed Cancer Center, Anderson, South Carolina 29621, United States
Hollings Cancer Center at Medical University of South Carolina, Charleston, South Carolina 29425, United States
McLeod Regional Medical Center, Florence, South Carolina 29501, United States
CCOP - Upstate Carolina, Spartanburg, South Carolina 29303, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center, Spartanburg, South Carolina 29303, United States
Huntsman Cancer Institute at University of Utah, Salt Lake City, Utah 84112, United States
St. Joseph Cancer Center, Bellingham, Washington 98225, United States
Olympic Hematology and Oncology, Bremerton, Washington 98310, United States
Columbia Basin Hematology, Kennewick, Washington 99336, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington 98104, United States
Group Health Central Hospital, Seattle, Washington 98112, United States
Harborview Medical Center, Seattle, Washington 98104, United States
Minor and James Medical, PLLC, Seattle, Washington 98104, United States
Polyclinic First Hill, Seattle, Washington 98122, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus, Seattle, Washington 98122-4307, United States
University Cancer Center at University of Washington Medical Center, Seattle, Washington 98195-6043, United States
Cancer Care Northwest - Spokane South, Spokane, Washington 99202, United States
Rocky Mountain Oncology, Casper, Wyoming 82609, United States
Welch Cancer Center at Sheridan Memorial Hospital, Sheridan, Wyoming 82801, United States
