Selumetinib in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma
This phase II clinical trial is studying how well selumetinib works in treating patients with relapsed or refractory diffuse large B-cell lymphoma. Selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Recurrent Adult Diffuse Large Cell Lymphoma
Other: diagnostic laboratory biomarker analysis
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Single-Arm Phase II Clinical Trial With the Novel MEK Inhibitor AZD-6244 for the Treatment of MCT-1 Related Relapsed or Refractory Diffuse Large B-Cell Lymphoma|
- Overall response rate (complete response and partial response) in patients treated with selumetinib [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]Estimates of the response rate based on best response [complete response (CR), and partial response (PR)] and the tumor control rate [CR, PR, and stable disease (SD)] will be provided together with the exact two-sided 95% confidence intervals.
- Duration of response [ Time Frame: From the documented beginning of response (CR or PR) to the time of relapse, assessed up to 3 years ] [ Designated as safety issue: No ]The Kaplan-Meier procedure will be used to characterize the survivorship function. Median time-to-events and the corresponding two-sided 95% confidence intervals will be provided for each of these variables.
- Overall survival [ Time Frame: The date of study entry to the date of death, assessed up to 3 years ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: The time from entry onto study until lymphoma progression or death from any cause, assessed up to 3 years ] [ Designated as safety issue: No ]The Kaplan-Meier procedure will be used to characterize the survivorship function. Median time-to-events and the corresponding two-sided 95% confidence intervals will be provided for each of these variables.
- Time to treatment failure [ Time Frame: From the time from study entry to any treatment failure, assessed up to 3 years ] [ Designated as safety issue: No ]
- Incidence of adverse events [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]The descriptions and grading scales found in the CTEP Version 4 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
|Study Start Date:||December 2010|
|Estimated Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
Experimental: Treatment (selumetinib)
Patients receive selumetinib PO twice daily on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Other Names:Other: diagnostic laboratory biomarker analysis
I. To evaluate the overall response rate (combined complete remission [CR] and partial remission [PR]) of AZD6244 hyd-sulfate anti-MEK (selumetinib) therapy for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
I. To evaluate the safety and tolerability of MEK inhibitor therapy. II. To determine the progression-free survival, time to treatment failure, duration of response, and overall survival with AZD6244 hyd-sulfate therapy.
III. To examine biomarkers through down-regulation of pERK and several relevant target substrates (e.g., MCT-1, MNK, ELK, c-MYC, and HIF-1alpha) in peripheral blood studies.
OUTLINE: This is a multicenter study.
Patients receive selumetinib orally (PO) twice daily on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo blood sample and tumor tissue collection at baseline and at day 15 of course 1 for biomarker studies.
After completion of study therapy, patients are followed up every 3 months for up to 3 years.
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Contact: Leo I. Gordon 312-695-4546 firstname.lastname@example.org|
|Principal Investigator: Leo I. Gordon|
|University of Chicago Comprehensive Cancer Center||Recruiting|
|Chicago, Illinois, United States, 60637-1470|
|Contact: Sonali M. Smith email@example.com|
|Principal Investigator: Walter M. Stadler|
|Principal Investigator: Sonali M. Smith|
|Decatur Memorial Hospital||Recruiting|
|Decatur, Illinois, United States, 62526|
|Contact: Krishna A. Rao firstname.lastname@example.org|
|Principal Investigator: Krishna A. Rao|
|Evanston CCOP-NorthShore University HealthSystem||Recruiting|
|Evanston, Illinois, United States, 60201|
|Contact: Bruce E. Brockstein email@example.com|
|Principal Investigator: Bruce E. Brockstein|
|Ingalls Memorial Hospital||Recruiting|
|Harvey, Illinois, United States, 60426|
|Contact: Mark F. Kozloff firstname.lastname@example.org|
|Principal Investigator: Sulochana D. Yalavarthi|
|Principal Investigator: Mark F. Kozloff|
|Peoria, Illinois, United States, 61615|
|Contact: Timothy M. Kuzel email@example.com|
|Principal Investigator: Sachdev P. Thomas|
|Principal Investigator: Timothy M. Kuzel|
|Southern Illinois University||Recruiting|
|Springfield, Illinois, United States, 62702|
|Contact: James L. Wade firstname.lastname@example.org|
|Principal Investigator: John E. Godwin|
|Principal Investigator: James L. Wade|
|United States, Indiana|
|Fort Wayne Medical Oncology and Hematology Inc - State Boulevard||Recruiting|
|Fort Wayne, Indiana, United States, 46845|
|Contact: Sreenivasa R. Nattam email@example.com|
|Principal Investigator: Sreenivasa R. Nattam|
|Indiana University Medical Center||Recruiting|
|Indianapolis, Indiana, United States, 46202|
|Contact: Noah M. Hahn firstname.lastname@example.org|
|Principal Investigator: Noah M. Hahn|
|United States, Maryland|
|University of Maryland Greenebaum Cancer Center||Recruiting|
|Baltimore, Maryland, United States, 21201-1595|
|Contact: Martin J. Edelman email@example.com|
|Principal Investigator: Aaron P. Rapoport|
|Principal Investigator: Martin J. Edelman|
|Saint Joseph Medical Center||Recruiting|
|Towson, Maryland, United States, 21204|
|Contact: Richard M. Schraeder firstname.lastname@example.org|
|Principal Investigator: Richard M. Schraeder|
|United States, Massachusetts|
|University of Massachusetts Medical School||Recruiting|
|Worcester, Massachusetts, United States, 01655|
|Contact: Andrew J. Evans 212-523-7170 email@example.com|
|Principal Investigator: Andrew J. Evans|
|United States, Michigan|
|University of Michigan University Hospital||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Maha H. Hussain firstname.lastname@example.org|
|Principal Investigator: Maha H. Hussain|
|United States, Missouri|
|Saint John's Mercy Medical Center||Recruiting|
|Saint Louis, Missouri, United States, 63141|
|Contact: Bethany G. Sleckman Bethany.Sleckman@Mercy.Net|
|Principal Investigator: Bethany G. Sleckman|
|United States, New York|
|Weill Medical College of Cornell University||Recruiting|
|New York, New York, United States, 10065|
|Contact: Jia Ruan email@example.com|
|Principal Investigator: Rebecca L. Elstrom|
|Principal Investigator: Jia Ruan|
|Principal Investigator:||Leo Gordon||University of Chicago Comprehensive Cancer Center|