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Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00006125 |
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 |
MedlinePlus related topics: | Cancer Lymphoma |
ChemIDplus related topics: | Doxorubicin Doxorubicin hydrochloride Topotecan hydrochloride Topotecan |
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) |
Study Start Date: | July 2000 |
OBJECTIVES:
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed recurrent or refractory non-Hodgkin's lymphoma of one of the following subtypes:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Show 76 Study Locations |
Cancer and Leukemia Group B |
National Cancer Institute (NCI) |
Study Chair: | Nancy L. Bartlett, MD | Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Smith SM, Johnson JL, Niedzwiecki D, Eder JP, Canellos G, Cheson BD, Bartlett NL, Cancer and Leukemia Group B. Sequential doxorubicin and topotecan in relapsed/refractory aggressive non-Hodgkin's lymphoma: results of CALGB 59906. Leuk Lymphoma. 2006 Aug;47(8):1511-7.
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Smith SM, Johnson JL, Niedzwiecki D, et al.: Sequential topoisomerase I (topo I) and topoisomerase II (topo II) inhibitors in relapsed/refractory aggressive NHL: results of CALGB 59906, a phase II study of doxorubicin and topotecan. [Abstract] Blood 104 (11): A-2500, 2004.
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Study ID Numbers: | CDR0000068140, CLB-59906 |
First Received: | August 3, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00006125 |
Health Authority: | United States: Federal Government |
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