Combination Chemotherapy in Treating Patients With Relapsed or Refractory Intermediate-Grade or High-Grade Non-Hodgkin's Lymphoma
- Conditions
- Lymphoma
- Interventions
- Registration Number
- NCT00006125
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining doxorubicin and topotecan in treating patients who have relapsed or refractory intermediate-grade or high-grade non-Hodgkin's lymphoma.
- Detailed Description
OBJECTIVES:
* Determine the response rate and time to progression in patients with relapsed or refractory intermediate or high grade non-Hodgkin's lymphoma treated with doxorubicin and topotecan.
* Determine the toxicity of this regimen in these patients.
OUTLINE: Patients receive doxorubicin IV over 5-10 minutes on day 1 and topotecan IV over 30 minutes on days 3-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression.
Patients are followed every 6 months for 2 years and annually for the next 3 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Doxorubicin + topotecan topotecan hydrochloride Patients receive doxorubicin IV over 5-10 minutes on day 1 and topotecan IV over 30 minutes on days 3-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression. Patients are followed every 6 months for 2 years and annually for the next 3 years. Doxorubicin + topotecan doxorubicin hydrochloride Patients receive doxorubicin IV over 5-10 minutes on day 1 and topotecan IV over 30 minutes on days 3-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression. Patients are followed every 6 months for 2 years and annually for the next 3 years.
- Primary Outcome Measures
Name Time Method Response rate Up to 5 years
- Secondary Outcome Measures
Name Time Method Time to progression Up to 5 years
Trial Locations
- Locations (76)
Veterans Affairs Medical Center - Chicago (Westside Hospital)
🇺🇸Chicago, Illinois, United States
Lenoir Memorial Hospital Cancer Center
🇺🇸Kinston, North Carolina, United States
Arthur G. James Cancer Hospital - Ohio State University
🇺🇸Columbus, Ohio, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
Hematology Oncology Associates of the Quad Cities
🇺🇸Bettendorf, Iowa, United States
Saint Anthony Medical Center
🇺🇸Rockford, Illinois, United States
Broward General Medical Center
🇺🇸Fort Lauderdale, Florida, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Fort Wayne Medical Oncology and Hematology, Incorporated
🇺🇸Fort Wayne, Indiana, United States
CCOP - Christiana Care Health Services
🇺🇸Newark, Delaware, United States
Veterans Affairs Medical Center - Washington, DC
🇺🇸Washington, District of Columbia, United States
University of Massachusetts Memorial Medical Center - University Campus
🇺🇸Worcester, Massachusetts, United States
Elmhurst Hospital Center
🇺🇸Elmhurst, New York, United States
State University of New York - Upstate Medical University
🇺🇸Syracuse, New York, United States
Vermont Cancer Center
🇺🇸Burlington, Vermont, United States
Veterans Affairs Medical Center - Buffalo
🇺🇸Buffalo, New York, United States
Martha Jefferson Hospital
🇺🇸Charlottesville, Virginia, United States
New Hanover Regional Medical Center
🇺🇸Wilmington, North Carolina, United States
Veterans Affairs Medical Center - Fargo
🇺🇸Fargo, North Dakota, United States
Ministry Medical Group - Northern Region
🇺🇸Rhinelander, Wisconsin, United States
Veterans Affairs Medical Center - Baltimore
🇺🇸Baltimore, Maryland, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
MBCCOP - Massey Cancer Center
🇺🇸Richmond, Virginia, United States
NorthEast Oncology Associates
🇺🇸Concord, North Carolina, United States
Cape Fear Valley Health System
🇺🇸Fayetteville, North Carolina, United States
Green Mountain Oncology Group
🇺🇸Bennington, Vermont, United States
Veterans Affairs Medical Center - Asheville
🇺🇸Asheville, North Carolina, United States
FirstHealth Moore Regional Hospital
🇺🇸Pinehurst, North Carolina, United States
University of Puerto Rico School of Medicine Medical Sciences Campus
🇵🇷San Juan, Puerto Rico
Veterans Affairs Medical Center - Dallas
🇺🇸Dallas, Texas, United States
Oncology and Hematology Associates of Southwest Virginia, Inc.
🇺🇸Roanoke, Virginia, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
CCOP - Southern Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
Veterans Affairs Medical Center - Las Vegas
🇺🇸Las Vegas, Nevada, United States
UCSF Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Veterans Affairs Medical Center - San Francisco
🇺🇸San Francisco, California, United States
Veterans Affairs Medical Center - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
University of Minnesota Cancer Center
🇺🇸Minneapolis, Minnesota, United States
Veterans Affairs Medical Center - Durham
🇺🇸Durham, North Carolina, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Barnes-Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
Veterans Affairs Medical Center - Syracuse
🇺🇸Syracuse, New York, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Northeast Alabama Regional Medical Center
🇺🇸Anniston, Alabama, United States
Rebecca and John Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States
Veterans Affairs Medical Center - San Diego
🇺🇸San Diego, California, United States
Lombardi Cancer Center
🇺🇸Washington, District of Columbia, United States
CCOP - Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Memorial Regional Hospital Comprehensive Cancer Center
🇺🇸Hollywood, Florida, United States
Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center
🇺🇸West Palm Beach, Florida, United States
West Suburban Center for Cancer Care
🇺🇸River Forest, Illinois, United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
🇺🇸Baltimore, Maryland, United States
Holden Comprehensive Cancer Center
🇺🇸Iowa City, Iowa, United States
Lakeland Medical Center - St. Joseph
🇺🇸Saint Joseph, Michigan, United States
Ellis Fischel Cancer Center - Columbia
🇺🇸Columbia, Missouri, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Norris Cotton Cancer Center
🇺🇸Lebanon, New Hampshire, United States
Queens Cancer Center of Queens Hospital
🇺🇸Jamaica, New York, United States
Mount Sinai Medical Center, NY
🇺🇸New York, New York, United States
CCOP - North Shore University Hospital
🇺🇸Manhasset, New York, United States
Weill Medical College of Cornell University
🇺🇸New York, New York, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
🇺🇸Syracuse, New York, United States
Lifespan: The Miriam Hospital
🇺🇸Providence, Rhode Island, United States
Veterans Affairs Medical Center - White River Junction
🇺🇸White River Junction, Vermont, United States
Louis A. Weiss Memorial Hospital
🇺🇸Chicago, Illinois, United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
🇺🇸Columbia, Missouri, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Virginia Oncology Associates - Norfolk
🇺🇸Norfolk, Virginia, United States
St. Mary's Medical Center
🇺🇸Huntington, West Virginia, United States
Cooper University Hospital
🇺🇸Camden, New Jersey, United States
Florida Hospital Cancer Institute
🇺🇸Orlando, Florida, United States
Baptist Hospital East - Louisville
🇺🇸Louisville, Kentucky, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, United States
CCOP - Southeast Cancer Control Consortium
🇺🇸Winston-Salem, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States