Lymphoma Clinical Trial
Official title:
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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