Combination Chemotherapy in Treating Patients With Relapsed or Refractory Intermediate-Grade or High-Grade Non-Hodgkin's Lymphoma - Full Text View

Sponsor:	Cancer and Leukemia Group B
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00006125

Purpose

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.

Condition	Intervention	Phase
Lymphoma	Drug: doxorubicin hydrochloride Drug: topotecan hydrochloride	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Phase II Study of Sequential Doxorubicin and Topotecan (Dox/Topo) in Relapsed or Refractory Intermediate- or High-Grade Non-Hodgkin's Lymphoma (NHL)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Myocet Topotecan hydrochloride Topotecan

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

July 2000

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.

PROJECTED ACCRUAL: Approximately 55 patients will be accrued for this study over 2.5 years.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed recurrent or refractory non-Hodgkin's lymphoma of one of the following subtypes:
- Follicular center lymphoma, grade 3
- Diffuse large B-cell lymphoma
- Diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma
- Burkitt's lymphoma
- High grade B-cell lymphoma, Burkitt-like
- Anaplastic large cell lymphoma, CD30+ cell type
- Anaplastic large cell lymphoma, T-cell type
- Anaplastic large cell lymphoma, null-cell type
- Anaplastic large cell lymphoma, Hodgkin's like
Bidimensionally measurable disease NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS:

Age:

Any age

Performance status:

Not specified

Life expectancy:

Not specified

Hematopoietic:

Absolute neutrophil count at least 1,500/mm3
Platelet count at least 100,000/mm3

Hepatic:

Bilirubin no greater than 2.0 mg/dL history of Gilbert's Disease
AST no greater than 2.5 times upper limit of normal

Renal:

Creatinine normal

Cardiovascular:

LVEF at least 45% by MUGA or echocardiogram

Other:

Not pregnant or nursing
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

Greater than 3 weeks since prior chemotherapy (6 weeks since prior nitrosoureas or mitomycin)
No greater than 96 mg/m2 mitoxantrone
No greater than 400 mg/m2 prior doxorubicin or combined total doxorubicin and mitoxantrone
No prior camptothecins
No other concurrent chemotherapy

Endocrine therapy:

No concurrent hormonal therapy except steroids for adrenal failure or hormones given for nondisease conditions (e.g., insulin for diabetes)
No concurrent dexamethasone or other steroidal antiemetics

Radiotherapy:

Greater than 3 weeks since prior radiotherapy
No concurrent radiotherapy except whole brain irradiation for documented CNS disease

Surgery:

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006125

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Locations

United States, Alabama
Northeast Alabama Regional Medical Center
Anniston, Alabama, United States, 36207
United States, California
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States, 92093-0658
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94115
Veterans Affairs Medical Center - San Diego
San Diego, California, United States, 92161
Veterans Affairs Medical Center - San Francisco
San Francisco, California, United States, 94121
United States, Delaware
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
United States, District of Columbia
Lombardi Cancer Center
Washington, District of Columbia, United States, 20007
Veterans Affairs Medical Center - Washington, DC
Washington, District of Columbia, United States, 20422
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307-5000
United States, Florida
Broward General Medical Center
Fort Lauderdale, Florida, United States, 33316
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
Florida Hospital Cancer Institute
Orlando, Florida, United States, 32804
Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center
West Palm Beach, Florida, United States, 33401
Memorial Regional Hospital Comprehensive Cancer Center
Hollywood, Florida, United States, 33021
United States, Illinois
West Suburban Center for Cancer Care
River Forest, Illinois, United States, 60305
Saint Anthony Medical Center
Rockford, Illinois, United States, 61108
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, United States, 60612
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States, 60640
United States, Indiana
Fort Wayne Medical Oncology and Hematology, Incorporated
Fort Wayne, Indiana, United States, 46885-5099
United States, Iowa
Hematology Oncology Associates of the Quad Cities
Bettendorf, Iowa, United States, 52722
Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242-1009
United States, Kentucky
Baptist Hospital East - Louisville
Louisville, Kentucky, United States, 40207
United States, Maryland
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States, 21201
Veterans Affairs Medical Center - Baltimore
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
University of Massachusetts Memorial Medical Center - University Campus
Worcester, Massachusetts, United States, 01655
United States, Michigan
Lakeland Medical Center - St. Joseph
Saint Joseph, Michigan, United States, 49085
United States, Minnesota
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, United States, 55417
United States, Missouri
Barnes-Jewish Hospital
Saint Louis, Missouri, United States, 63110
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, United States, 65203
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, United States, 65201
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-7680
United States, Nevada
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
Veterans Affairs Medical Center - Las Vegas
Las Vegas, Nevada, United States, 89106
United States, New Hampshire
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756-0002
United States, New Jersey
Cooper University Hospital
Camden, New Jersey, United States, 08103
United States, New York
CCOP - North Shore University Hospital
Manhasset, New York, United States, 11030
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, United States, 13217
Elmhurst Hospital Center
Elmhurst, New York, United States, 11373
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
State University of New York - Upstate Medical University
Syracuse, New York, United States, 13210
North Shore University Hospital
Manhasset, New York, United States, 11030
Queens Cancer Center of Queens Hospital
Jamaica, New York, United States, 11432
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Mount Sinai Medical Center, NY
New York, New York, United States, 10029
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, United States, 14215
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, United States, 13210
Weill Medical College of Cornell University
New York, New York, United States, 10021
United States, North Carolina
Cape Fear Valley Health System
Fayetteville, North Carolina, United States, 28302-2000
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States, 27104-4241
Lenoir Memorial Hospital Cancer Center
Kinston, North Carolina, United States, 28503-1678
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
FirstHealth Moore Regional Hospital
Pinehurst, North Carolina, United States, 28374
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1082
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States, 27599-7295
New Hanover Regional Medical Center
Wilmington, North Carolina, United States, 28402-9025
NorthEast Oncology Associates
Concord, North Carolina, United States, 28025
Veterans Affairs Medical Center - Asheville
Asheville, North Carolina, United States, 28805
Veterans Affairs Medical Center - Durham
Durham, North Carolina, United States, 27705
United States, North Dakota
Veterans Affairs Medical Center - Fargo
Fargo, North Dakota, United States, 58102
United States, Ohio
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210-1240
United States, Rhode Island
Lifespan: The Miriam Hospital
Providence, Rhode Island, United States, 02906
United States, Texas
Veterans Affairs Medical Center - Dallas
Dallas, Texas, United States, 75216
United States, Vermont
Green Mountain Oncology Group
Bennington, Vermont, United States, 05201
Vermont Cancer Center
Burlington, Vermont, United States, 05401-3498
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, United States, 05009
United States, Virginia
Martha Jefferson Hospital
Charlottesville, Virginia, United States, 22901
MBCCOP - Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
Oncology and Hematology Associates of Southwest Virginia, Inc.
Roanoke, Virginia, United States, 24014
Virginia Oncology Associates - Norfolk
Norfolk, Virginia, United States, 23502
United States, West Virginia
St. Mary's Medical Center
Huntington, West Virginia, United States, 25701
United States, Wisconsin
Ministry Medical Group - Northern Region
Rhinelander, Wisconsin, United States, 54501
Puerto Rico
University of Puerto Rico School of Medicine Medical Sciences Campus
San Juan, Puerto Rico, 00936-5067

Sponsors and Collaborators

Cancer and Leukemia Group B

National Cancer Institute (NCI)

Investigators

Study Chair:

Nancy L. Bartlett, MD

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

Study ID Numbers:	CDR0000068140, CLB-59906
Study First Received:	August 3, 2000
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00006125 History of Changes
Health Authority:	United States: Federal Government