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Brief Title: Arsenic Trioxide in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia
Official Title: A Phase II Trial of Arsenic Trioxide (NSC #706363) for Relapsed or Refractory Acute Lymphoblastic Leukemia
Study ID: NCT00006008
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have relapsed or refractory acute lymphoblastic leukemia.
Detailed Description: OBJECTIVES: * Determine the complete remission rate of patients with relapsed or refractory acute lymphoblastic leukemia treated with arsenic trioxide. * Determine the toxic effects of induction arsenic trioxide in this patient population. OUTLINE: Patients are stratified according to administration schedule of arsenic trioxide (5 days a week vs 7 days a week). Patients receive arsenic trioxide IV over 1 hour daily until bone marrow blasts are less than 5% or for a maximum of 60 days. Beginning 3-6 weeks after induction, patients achieving a complete remission receive arsenic trioxide IV over 1 hour daily either 5 days or 7 days a week for 25 days. Subsequent consolidation courses are given with 4 week treatment-free intervals between courses. Treatment continues for a maximum of 5 consolidation courses in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 13-40 patients will be accrued for this study within 3 years.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
CCOP - Scottsdale Oncology Program, Scottsdale, Arizona, United States
Cancer Center and Beckman Research Institute, City of Hope, Duarte, California, United States
Veterans Affairs Medical Center - Palo Alto, Palo Alto, California, United States
Stanford University Medical Center, Stanford, California, United States
CCOP - Colorado Cancer Research Program, Inc., Denver, Colorado, United States
CCOP - Christiana Care Health Services, Wilmington, Delaware, United States
Veterans Affairs Medical Center - Gainsville, Gainesville, Florida, United States
Veterans Affairs Medical Center - Miami, Miami, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
Veterans Affairs Medical Center - Tampa (Haley), Tampa, Florida, United States
Emory University Hospital - Atlanta, Atlanta, Georgia, United States
Veterans Affairs Medical Center - Atlanta (Decatur), Decatur, Georgia, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois, United States
Veterans Affairs Medical Center - Lakeside Chicago, Chicago, Illinois, United States
CCOP - Central Illinois, Decatur, Illinois, United States
CCOP - Evanston, Evanston, Illinois, United States
CCOP - Illinois Oncology Research Association, Peoria, Illinois, United States
CCOP - Carle Cancer Center, Urbana, Illinois, United States
Indiana University Cancer Center, Indianapolis, Indiana, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush), Indianapolis, Indiana, United States
CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa, United States
CCOP - Iowa Oncology Research Association, Des Moines, Iowa, United States
Holden Comprehensive Cancer Center at The University of Iowa, Iowa City, Iowa, United States
MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana, United States
CCOP - Ochsner, New Orleans, Louisiana, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
New England Medical Center Hospital, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
CCOP - Ann Arbor Regional, Ann Arbor, Michigan, United States
CCOP - Kalamazoo, Kalamazoo, Michigan, United States
CCOP - Duluth, Duluth, Minnesota, United States
Veterans Affairs Medical Center - Minneapolis, Minneapolis, Minnesota, United States
University of Minnesota Cancer Center, Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, United States
Veterans Affairs Medical Center - Omaha, Omaha, Nebraska, United States
CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska, United States
CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada, United States
Veterans Affairs Medical Center - East Orange, East Orange, New Jersey, United States
CCOP - Northern New Jersey, Hackensack, New Jersey, United States
Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Albert Einstein Comprehensive Cancer Center, Bronx, New York, United States
Veterans Affairs Medical Center - Brooklyn, Brooklyn, New York, United States
Veterans Affairs Medical Center - New York, New York, New York, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York, New York, United States
CCOP - Merit Care Hospital, Fargo, North Dakota, United States
Ireland Cancer Center, Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
CCOP - Columbus, Columbus, Ohio, United States
CCOP - Toledo Community Hospital Oncology Program, Toledo, Ohio, United States
CCOP - Oklahoma, Tulsa, Oklahoma, United States
CCOP - Geisinger Clinic and Medical Center, Danville, Pennsylvania, United States
Hahnemann University Hospital, Philadelphia, Pennsylvania, United States
University of Pennsylvania Cancer Center, Philadelphia, Pennsylvania, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, United States
Veterans Affairs Medical Center - Pittsburgh, Pittsburgh, Pennsylvania, United States
CCOP - MainLine Health, Wynnewood, Pennsylvania, United States
CCOP - Sioux Community Cancer Consortium, Sioux Falls, South Dakota, United States
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus, Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States
Veterans Affairs Medical Center - Madison, Madison, Wisconsin, United States
University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, United States
CCOP - Marshfield Medical Research and Education Foundation, Marshfield, Wisconsin, United States
Marshfield Clinic, Marshfield, Wisconsin, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki), Milwaukee, Wisconsin, United States
MBCCOP - San Juan, San Juan, , Puerto Rico
Veterans Affairs Medical Center - San Juan, San Juan, , Puerto Rico
Pretoria Academic Hospitals, Pretoria, , South Africa
Name: Mark R. Litzow, MD
Affiliation: Mayo Clinic
Role: STUDY_CHAIR