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PHASE II STUDY OF 9-AMINOCAMPTOTHECIN (9-AC/DMA, NSC# 603071) IN PREVIOUSLY TREATED HODGKIN'S DISEASE AND NON-HODGKIN'S LYMPHOMA: IWF GRADES A-H
Phase II trial to study the effectiveness of aminocamptothecin in treating patients who have refractory or recurrent Hodgkin's disease or non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
OBJECTIVES: I. Evaluate the response rate and duration of response to aminocamptothecin (9-AC) in patients with refractory or relapsed Hodgkin's disease or non-Hodgkin's lymphoma. II. Assess the toxicity of 9-AC in these patients. III. Validate a preliminary pharmacodynamic model relating total 9-AC concentration, albumin, and bilirubin to toxicity. IV. Determine whether 9-AC concentrations correlate with response. OUTLINE: Patients are stratified by disease histology (International Working Formulation (IWF) A-C vs IWF D-F) and center. Patients receive aminocamptothecin IV continuously on days 1-3. Treatment repeats every 2 weeks for a minimum of 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve stable disease, partial response (PR), or complete response (CR) may receive 2 additional courses past best response (minimum of 6 courses if PR or CR). Patients are followed every 6 months for 2 years, and then annually thereafter.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
Washington University Barnard Cancer Center
St Louis, Missouri, United States
Cooper Cancer Institute
Camden, New Jersey, United States
St. Joseph's Hospital and Medical Center
Paterson, New Jersey, United States
Start Date
April 1, 1996
Primary Completion Date
April 1, 2003
Completion Date
January 1, 2008
Last Updated
February 11, 2013
37
ACTUAL participants
aminocamptothecin
DRUG
Lead Sponsor
National Cancer Institute (NCI)
NCT05529069
NCT07388563
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