Arsenic Trioxide in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia
- Conditions
- Leukemia
- Registration Number
- NCT00006008
- Lead Sponsor
- Eastern Cooperative Oncology Group
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (71)
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Veterans Affairs Medical Center - Lakeside Chicago
🇺🇸Chicago, Illinois, United States
New England Medical Center Hospital
🇺🇸Boston, Massachusetts, United States
University of Pittsburgh Cancer Institute
🇺🇸Pittsburgh, Pennsylvania, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
🇺🇸Indianapolis, Indiana, United States
Veterans Affairs Medical Center - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
University of Minnesota Cancer Center
🇺🇸Minneapolis, Minnesota, United States
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
🇺🇸Nashville, Tennessee, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Veterans Affairs Medical Center - Omaha
🇺🇸Omaha, Nebraska, United States
CCOP - Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
🇺🇸Milwaukee, Wisconsin, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
Veterans Affairs Medical Center - Miami
🇺🇸Miami, Florida, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
CCOP - Central Illinois
🇺🇸Decatur, Illinois, United States
Emory University Hospital - Atlanta
🇺🇸Atlanta, Georgia, United States
Veterans Affairs Medical Center - Atlanta (Decatur)
🇺🇸Decatur, Georgia, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
🇺🇸New York, New York, United States
CCOP - Northern New Jersey
🇺🇸Hackensack, New Jersey, United States
CCOP - Southern Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
Albert Einstein Comprehensive Cancer Center
🇺🇸Bronx, New York, United States
Veterans Affairs Medical Center - East Orange
🇺🇸East Orange, New Jersey, United States
Veterans Affairs Medical Center - New York
🇺🇸New York, New York, United States
Ireland Cancer Center
🇺🇸Cleveland, Ohio, United States
Veterans Affairs Medical Center - Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
CCOP - Oklahoma
🇺🇸Tulsa, Oklahoma, United States
CCOP - Geisinger Clinic and Medical Center
🇺🇸Danville, Pennsylvania, United States
University of Pennsylvania Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
CCOP - Toledo Community Hospital Oncology Program
🇺🇸Toledo, Ohio, United States
MBCCOP - San Juan
🇵🇷San Juan, Puerto Rico
Veterans Affairs Medical Center - San Juan
🇵🇷San Juan, Puerto Rico
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
Veterans Affairs Medical Center - Madison
🇺🇸Madison, Wisconsin, United States
Pretoria Academic Hospitals
🇿🇦Pretoria, South Africa
CCOP - Merit Care Hospital
🇺🇸Fargo, North Dakota, United States
Veterans Affairs Medical Center - Brooklyn
🇺🇸Brooklyn, New York, United States
Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
CCOP - MainLine Health
🇺🇸Wynnewood, Pennsylvania, United States
CCOP - Ann Arbor Regional
🇺🇸Ann Arbor, Michigan, United States
CCOP - Scottsdale Oncology Program
🇺🇸Scottsdale, Arizona, United States
Cancer Center and Beckman Research Institute, City of Hope
🇺🇸Duarte, California, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
🇺🇸Chicago, Illinois, United States
CCOP - Colorado Cancer Research Program, Inc.
🇺🇸Denver, Colorado, United States
Veterans Affairs Medical Center - Palo Alto
🇺🇸Palo Alto, California, United States
CCOP - Evanston
🇺🇸Evanston, Illinois, 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
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
CCOP - Kalamazoo
🇺🇸Kalamazoo, Michigan, United States
CCOP - Duluth
🇺🇸Duluth, Minnesota, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
Hahnemann University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
CCOP - Sioux Community Cancer Consortium
🇺🇸Sioux Falls, South Dakota, United States
University of Wisconsin Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
Marshfield Clinic
🇺🇸Marshfield, Wisconsin, United States
CCOP - Marshfield Medical Research and Education Foundation
🇺🇸Marshfield, Wisconsin, United States
Veterans Affairs Medical Center - Tampa (Haley)
🇺🇸Tampa, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
CCOP - Ochsner
🇺🇸New Orleans, Louisiana, United States
Veterans Affairs Medical Center - Gainsville
🇺🇸Gainesville, Florida, United States
MBCCOP - LSU Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
CCOP - Christiana Care Health Services
🇺🇸Wilmington, Delaware, United States