A Phase II Trial of Arsenic Trioxide (NSC #706363) for Relapsed or Refractory Acute Lymphoblastic Leukemia
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.
Interventional
Primary Purpose: Treatment
Mark R. Litzow, MD
Study Chair
Mayo Clinic
United States: Federal Government
CDR0000068016
NCT00006008
June 2000
September 2006
Name | Location |
---|---|
Albert Einstein Comprehensive Cancer Center | Bronx, New York 10461 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
Stanford University Medical Center | Stanford, California 94305-5408 |
H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
Emory University Hospital - Atlanta | Atlanta, Georgia 30322 |
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
CCOP - Ann Arbor Regional | Ann Arbor, Michigan 48106 |
University of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago, Illinois 60611 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
CCOP - Southern Nevada Cancer Research Foundation | Las Vegas, Nevada 89106 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Colorado Cancer Research Program, Inc. | Denver, Colorado 80209-5031 |
Veterans Affairs Medical Center - Atlanta (Decatur) | Decatur, Georgia 30033 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
Veterans Affairs Medical Center - Indianapolis (Roudebush) | Indianapolis, Indiana 46202 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
New England Medical Center Hospital | Boston, Massachusetts 02111 |
CCOP - Kalamazoo | Kalamazoo, Michigan 49007-3731 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Veterans Affairs Medical Center - East Orange | East Orange, New Jersey 07018-1095 |
CCOP - Northern New Jersey | Hackensack, New Jersey 07601 |
Hahnemann University Hospital | Philadelphia, Pennsylvania 19102-1192 |
University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15213 |
CCOP - Duluth | Duluth, Minnesota 55805 |
Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
CCOP - Scottsdale Oncology Program | Scottsdale, Arizona 85259-5404 |
CCOP - Cedar Rapids Oncology Project | Cedar Rapids, Iowa 52403-1206 |
CCOP - Ochsner | New Orleans, Louisiana 70121 |
CCOP - Merit Care Hospital | Fargo, North Dakota 58122 |
CCOP - Toledo Community Hospital Oncology Program | Toledo, Ohio 43623-3456 |
CCOP - Sioux Community Cancer Consortium | Sioux Falls, South Dakota 57105-1080 |
Holden Comprehensive Cancer Center at The University of Iowa | Iowa City, Iowa 52242-1009 |
NYU School of Medicine's Kaplan Comprehensive Cancer Center | New York, New York 10016 |
Marshfield Clinic | Marshfield, Wisconsin 54449 |
Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
CCOP - Central Illinois | Springfield, Illinois 62526 |
CCOP - Columbus | Columbus, Ohio 43206 |
CCOP - MainLine Health | Wynnewood, Pennsylvania 19096 |
Veterans Affairs Medical Center - Madison | Madison, Wisconsin 53705 |
University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
Veterans Affairs Medical Center - Milwaukee (Zablocki) | Milwaukee, Wisconsin 53295 |
CCOP - Evanston | Evanston, Illinois 60201 |
CCOP - Geisinger Clinic and Medical Center | Danville, Pennsylvania 17822-2001 |
Veterans Affairs Medical Center - Lakeside Chicago | Chicago, Illinois 60611 |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
Veterans Affairs Medical Center - New York | New York, New York 10010 |
CCOP - Marshfield Medical Research and Education Foundation | Marshfield, Wisconsin 54449 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
Cancer Center and Beckman Research Institute, City of Hope | Duarte, California 91010-3000 |
MBCCOP - LSU Health Sciences Center | New Orleans, Louisiana 70112 |
CCOP - Oklahoma | Tulsa, Oklahoma 74136 |
Veterans Affairs Medical Center - Pittsburgh | Pittsburgh, Pennsylvania 15240 |
Veterans Affairs Medical Center - Miami | Miami, Florida 33125 |
Cancer Institute of New Jersey | New Brunswick, New Jersey 08901 |
Veterans Affairs Medical Center - Minneapolis | Minneapolis, Minnesota 55417 |
Veterans Affairs Medical Center - Palo Alto | Palo Alto, California 94304 |
Veterans Affairs Medical Center - Brooklyn | Brooklyn, New York 11209 |
Veterans Affairs Medical Center - Tampa (Haley) | Tampa, Florida 33612 |
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus | Nashville, Tennessee 37212 |
Veterans Affairs Medical Center - Gainsville | Gainesville, Florida 32608-1197 |
Veterans Affairs Medical Center - Omaha | Omaha, Nebraska 68105 |