Aminocamptothecin in Treating Patients With Refractory or Recurrent Hodgkin's Disease or Non-Hodgkin's Lymphoma
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|ClinicalTrials.gov Identifier: NCT00002745|
Recruitment Status : Completed
First Posted : April 22, 2004
Last Update Posted : February 11, 2013
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Drug: aminocamptothecin||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||April 1996|
|Actual Primary Completion Date :||April 2003|
|Actual Study Completion Date :||January 2008|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|