Aminocamptothecin in Treating Patients With Refractory or Recurrent Hodgkin's Disease or Non-Hodgkin's Lymphoma
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Response [ Time Frame: 2 years post treatment ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: day 1 of each cycle ] [ Designated as safety issue: Yes ]
- 9-AC/DMA concentrations [ Time Frame: Pre-treatment cycle 1 and just prior to completion of cycle 1 ] [ Designated as safety issue: No ]
|Study Start Date:||April 1996|
|Study Completion Date:||January 2008|
|Primary Completion Date:||April 2003 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002745
|United States, District of Columbia|
|Walter Reed Army Medical Center|
|Washington, District of Columbia, United States, 20307-5000|
|United States, Minnesota|
|University of Minnesota Cancer Center|
|Minneapolis, Minnesota, United States, 55455|
|United States, Missouri|
|Washington University Barnard Cancer Center|
|Saint Louis, Missouri, United States, 63110|
|United States, New Jersey|
|Cooper Cancer Institute|
|Camden, New Jersey, United States, 08103|
|St. Joseph's Hospital and Medical Center|
|Paterson, New Jersey, United States, 07503|
|Study Chair:||Nancy L. Bartlett, MD||Washington University Siteman Cancer Center|