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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
850 micrograms/square meter/day (total dose 2550 micrograms/square meter) via central venous catheter using infusion pump over 72 hours + one cycle Cycle repeated every 14 days for minimum of 6 cycles if partial or complete response
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
Response
Time frame: 2 years post treatment
Toxicity
Time frame: day 1 of each cycle
9-AC/DMA concentrations
Time frame: Pre-treatment cycle 1 and just prior to completion of cycle 1
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St. Joseph's Hospital and Medical Center
Paterson, New Jersey, United States