Combination Chemotherapy in Treating Patients With Relapsed or Refractory Intermediate-Grade or High-Grade Non-Hodgkin's Lymphoma
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Doxorubicin + topotecan 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. |
Drug: doxorubicin hydrochloride
Drug: topotecan hydrochloride
|
Outcome Measures
Primary Outcome Measures
- Response rate [Up to 5 years]
Secondary Outcome Measures
- Time to progression [Up to 5 years]
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
-
Histologically confirmed recurrent or refractory non-Hodgkin's lymphoma of one of the following subtypes:
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Follicular center lymphoma, grade 3
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Diffuse large B-cell lymphoma
-
Diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma
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Burkitt's lymphoma
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High grade B-cell lymphoma, Burkitt-like
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Anaplastic large cell lymphoma, CD30+ cell type
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Anaplastic large cell lymphoma, T-cell type
-
Anaplastic large cell lymphoma, null-cell type
-
Anaplastic large cell lymphoma, Hodgkin's like
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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
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Northeast Alabama Regional Medical Center | Anniston | Alabama | United States | 36207 |
2 | Rebecca and John Moores UCSD Cancer Center | La Jolla | California | United States | 92093-0658 |
3 | Veterans Affairs Medical Center - San Diego | San Diego | California | United States | 92161 |
4 | UCSF Comprehensive Cancer Center | San Francisco | California | United States | 94115 |
5 | Veterans Affairs Medical Center - San Francisco | San Francisco | California | United States | 94121 |
6 | CCOP - Christiana Care Health Services | Newark | Delaware | United States | 19713 |
7 | Lombardi Cancer Center | Washington | District of Columbia | United States | 20007 |
8 | Walter Reed Army Medical Center | Washington | District of Columbia | United States | 20307-5000 |
9 | Veterans Affairs Medical Center - Washington, DC | Washington | District of Columbia | United States | 20422 |
10 | Broward General Medical Center | Fort Lauderdale | Florida | United States | 33316 |
11 | Memorial Regional Hospital Comprehensive Cancer Center | Hollywood | Florida | United States | 33021 |
12 | CCOP - Mount Sinai Medical Center | Miami Beach | Florida | United States | 33140 |
13 | Florida Hospital Cancer Institute | Orlando | Florida | United States | 32804 |
14 | Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center | West Palm Beach | Florida | United States | 33401 |
15 | Veterans Affairs Medical Center - Chicago (Westside Hospital) | Chicago | Illinois | United States | 60612 |
16 | University of Chicago Cancer Research Center | Chicago | Illinois | United States | 60637-1470 |
17 | Louis A. Weiss Memorial Hospital | Chicago | Illinois | United States | 60640 |
18 | West Suburban Center for Cancer Care | River Forest | Illinois | United States | 60305 |
19 | Saint Anthony Medical Center | Rockford | Illinois | United States | 61108 |
20 | Fort Wayne Medical Oncology and Hematology, Incorporated | Fort Wayne | Indiana | United States | 46885-5099 |
21 | Hematology Oncology Associates of the Quad Cities | Bettendorf | Iowa | United States | 52722 |
22 | Holden Comprehensive Cancer Center | Iowa City | Iowa | United States | 52242-1009 |
23 | Baptist Hospital East - Louisville | Louisville | Kentucky | United States | 40207 |
24 | Marlene and Stewart Greenebaum Cancer Center, University of Maryland | Baltimore | Maryland | United States | 21201 |
25 | Veterans Affairs Medical Center - Baltimore | Baltimore | Maryland | United States | 21201 |
26 | Dana-Farber Cancer Institute | Boston | Massachusetts | United States | 02115 |
27 | University of Massachusetts Memorial Medical Center - University Campus | Worcester | Massachusetts | United States | 01655 |
28 | Lakeland Medical Center - St. Joseph | Saint Joseph | Michigan | United States | 49085 |
29 | Veterans Affairs Medical Center - Minneapolis | Minneapolis | Minnesota | United States | 55417 |
30 | University of Minnesota Cancer Center | Minneapolis | Minnesota | United States | 55455 |
31 | Veterans Affairs Medical Center - Columbia (Truman Memorial) | Columbia | Missouri | United States | 65201 |
32 | Ellis Fischel Cancer Center - Columbia | Columbia | Missouri | United States | 65203 |
33 | Barnes-Jewish Hospital | Saint Louis | Missouri | United States | 63110 |
34 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
35 | University of Nebraska Medical Center | Omaha | Nebraska | United States | 68198-7680 |
36 | CCOP - Southern Nevada Cancer Research Foundation | Las Vegas | Nevada | United States | 89106 |
37 | Veterans Affairs Medical Center - Las Vegas | Las Vegas | Nevada | United States | 89106 |
38 | Norris Cotton Cancer Center | Lebanon | New Hampshire | United States | 03756-0002 |
39 | Cooper University Hospital | Camden | New Jersey | United States | 08103 |
40 | Veterans Affairs Medical Center - Buffalo | Buffalo | New York | United States | 14215 |
41 | Roswell Park Cancer Institute | Buffalo | New York | United States | 14263-0001 |
42 | Elmhurst Hospital Center | Elmhurst | New York | United States | 11373 |
43 | Queens Cancer Center of Queens Hospital | Jamaica | New York | United States | 11432 |
44 | CCOP - North Shore University Hospital | Manhasset | New York | United States | 11030 |
45 | North Shore University Hospital | Manhasset | New York | United States | 11030 |
46 | Memorial Sloan-Kettering Cancer Center | New York | New York | United States | 10021 |
47 | Weill Medical College of Cornell University | New York | New York | United States | 10021 |
48 | Mount Sinai Medical Center, NY | New York | New York | United States | 10029 |
49 | State University of New York - Upstate Medical University | Syracuse | New York | United States | 13210 |
50 | Veterans Affairs Medical Center - Syracuse | Syracuse | New York | United States | 13210 |
51 | CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse | New York | United States | 13217 |
52 | Veterans Affairs Medical Center - Asheville | Asheville | North Carolina | United States | 28805 |
53 | Lineberger Comprehensive Cancer Center, UNC | Chapel Hill | North Carolina | United States | 27599-7295 |
54 | NorthEast Oncology Associates | Concord | North Carolina | United States | 28025 |
55 | Veterans Affairs Medical Center - Durham | Durham | North Carolina | United States | 27705 |
56 | Duke Comprehensive Cancer Center | Durham | North Carolina | United States | 27710 |
57 | Cape Fear Valley Health System | Fayetteville | North Carolina | United States | 28302-2000 |
58 | Lenoir Memorial Hospital Cancer Center | Kinston | North Carolina | United States | 28503-1678 |
59 | FirstHealth Moore Regional Hospital | Pinehurst | North Carolina | United States | 28374 |
60 | New Hanover Regional Medical Center | Wilmington | North Carolina | United States | 28402-9025 |
61 | CCOP - Southeast Cancer Control Consortium | Winston-Salem | North Carolina | United States | 27104-4241 |
62 | Comprehensive Cancer Center at Wake Forest University | Winston-Salem | North Carolina | United States | 27157-1082 |
63 | Veterans Affairs Medical Center - Fargo | Fargo | North Dakota | United States | 58102 |
64 | Arthur G. James Cancer Hospital - Ohio State University | Columbus | Ohio | United States | 43210-1240 |
65 | Lifespan: The Miriam Hospital | Providence | Rhode Island | United States | 02906 |
66 | Veterans Affairs Medical Center - Dallas | Dallas | Texas | United States | 75216 |
67 | Green Mountain Oncology Group | Bennington | Vermont | United States | 05201 |
68 | Vermont Cancer Center | Burlington | Vermont | United States | 05401-3498 |
69 | Veterans Affairs Medical Center - White River Junction | White River Junction | Vermont | United States | 05009 |
70 | Martha Jefferson Hospital | Charlottesville | Virginia | United States | 22901 |
71 | Virginia Oncology Associates - Norfolk | Norfolk | Virginia | United States | 23502 |
72 | MBCCOP - Massey Cancer Center | Richmond | Virginia | United States | 23298-0037 |
73 | Oncology and Hematology Associates of Southwest Virginia, Inc. | Roanoke | Virginia | United States | 24014 |
74 | St. Mary's Medical Center | Huntington | West Virginia | United States | 25701 |
75 | Ministry Medical Group - Northern Region | Rhinelander | Wisconsin | United States | 54501 |
76 | University of Puerto Rico School of Medicine Medical Sciences Campus | San Juan | Puerto Rico | 00936-5067 |
Sponsors and Collaborators
- Alliance for Clinical Trials in Oncology
- National Cancer Institute (NCI)
Investigators
- Study Chair: Nancy L. Bartlett, MD, Washington University Siteman Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CALGB-59906
- U10CA031946
- CLB-59906
- CDR0000068140