Imexon for Relapsed Follicular and Aggressive Lymphomas (ULYM11011)
The purpose of this study is to determine whether Amplimexon (imexon for injection) is effective in the treatment of indolent and aggressive lymphomas that have progressed after treatment with standard therapies.
Small Lymphocytic Lymphoma
Marginal Zone Lymphoma
Diffuse Large B Cell Lymphoma
Mantle Cell Lymphoma
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Amplimexon® (Imexon for Injection) for the Treatment of Previously Treated Follicular and Aggressive Lymphoma in Adults|
- Efficacy of imexon in the treatment of relapsed/refractory indolent lymphoma [ Time Frame: One year ] [ Designated as safety issue: No ]To investigate the anti-tumor activity (overall response rate) of imexon monotherapy in the treatment of subjects with indolent lymphoma that has progressed after treatment with standard chemo-immunotherapy, in order to determine whether future clinical trials with imexon is warranted in this population.
- Efficacy of imexon in the treatment of relapsed/refractory aggressive lymphomas [ Time Frame: One year ] [ Designated as safety issue: No ]To investigate the anti-tumor activity (overall response rate) of imexon in the treatment of subjects with relapsed aggressive histologies of lymphoma who have progressed after salvage auto-transplant or for whom auto-transplant is not appropriate, in order to determine whether future clinical trials with imexon is warranted in this population.
- Duration of response in relapsed/refractory indolent and aggressive lymphomas [ Time Frame: Until disease progression or death ] [ Designated as safety issue: No ]To document duration of response (measured from time when best response is determined until disease progression is documented or death from any cause, which ever event comes first) in relapsed/refractory indolent and aggressive lymphomas.
- Time to disease progression in relapsed/refractory follicular and aggressive lymphomas [ Time Frame: Until disease progression or death ] [ Designated as safety issue: No ]To document time to disease progression (measured from start of treatment until disease progression or death from any cause) in relapsed/refractory follicular and aggressive lymphomas.
|Study Start Date:||May 2011|
|Estimated Study Completion Date:||May 2015|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Subjects will be treated on Days 1-5 of 21-day treatment cycles for up to one year. Following pre-treatment with anti-emetics Amplimexon will be given by intravenous infusion over 60 minutes.
Amplimexon will be administered daily on Days 1-5 of 21-day treatment cycles as an intravenous infusion over a time course of 60 minutes. Subjects will receive 17 cycles of therapy for a total of one year on treatment. The Amplimexon starting dose for each subject in this study is 1000 mg/m² on each treatment day. Dose may be reduced by 25% for toxicity; after 2 dose reductions, subjects must be withdrawn from treatment.
Other Name: Amplimexon (imexon for injection)
A phase II exploratory trial of imexon in lymphoma is justified by: (1) the observation of clinical activity (partial response to the drug observed in phase I testing in a subject with refractory indolent lymphoma); (2) the finding that imexon prevents the development of human immunoblastic lymphoma in SCID mice; (3) the finding that lymphoma cell lines are killed by readily achievable doses; and (4) translational studies implicating the importance of the redox state of the cancer cell.
The dose and schedule chosen (1000 mg/m2 daily X 5 days every 3 weeks) is based on tolerability and subject acceptance in prior AmpliMed phase I studies.
The planned correlative studies should help to identify potential biomarkers for response to imexon and provide further insight into potential mechanisms of imexon action hypothesized from results of prior laboratory studies.
|United States, Arizona|
|Arizona Cancer Center, University of Arizona|
|Tucson, Arizona, United States, 85724|
|United States, New York|
|University of Rochester Medical Center|
|Rochester, New York, United States, 14642|
|Principal Investigator:||Paul M Barr, MD||University of Rochester|