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
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
2 years post treatment
Nancy L. Bartlett, MD
Washington University Siteman Cancer Center
United States: Food and Drug Administration
|Walter Reed Army Medical Center||Washington, District of Columbia 20307-5000|
|University of Minnesota Cancer Center||Minneapolis, Minnesota 55455|
|St. Joseph's Hospital and Medical Center||Paterson, New Jersey 07503|
|Cooper Cancer Institute||Camden, New Jersey 08103|
|Washington University Barnard Cancer Center||Saint Louis, Missouri 63110|