Aminocamptothecin in Treating Patients With Refractory or Recurrent Hodgkin's Disease or Non-Hodgkin's Lymphoma
- Registration Number
- NCT00002745
- Lead Sponsor
- National Cancer Institute (NCI)
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 37
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description aminocamptothecin aminocamptothecin aminocamptothecin
- Primary Outcome Measures
Name Time Method Response 2 years post treatment
- Secondary Outcome Measures
Name Time Method Toxicity day 1 of each cycle 9-AC/DMA concentrations Pre-treatment cycle 1 and just prior to completion of cycle 1
Trial Locations
- Locations (5)
St. Joseph's Hospital and Medical Center
🇺🇸Paterson, New Jersey, United States
Cooper Cancer Institute
🇺🇸Camden, New Jersey, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
University of Minnesota Cancer Center
🇺🇸Minneapolis, Minnesota, United States
Washington University Barnard Cancer Center
🇺🇸Saint Louis, Missouri, United States