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: 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 [CR] and partial response [PR]) 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 (CR and 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: Date of study entry to the date of death, assessed up to 3 years ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: 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: Time from study entry to any treatment failure, assessed up to 3 years ] [ Designated as safety issue: No ]
- Incidence of adverse events graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ].
|Study Start Date:||December 2010|
|Study Completion Date:||May 2014|
|Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Experimental: Treatment (selumetinib)
Patients receive selumetinib PO BID on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity
Other Names:Other: 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 phosphorylated extracellular signal-related kinase (pERK) and several relevant target substrates (e.g., monocarboxylate transporter-1 [MCT-1], Menkes disease-associated protein [MNK], ELK, c-v-myc avian myelocytomatosis viral oncogene homolog [c-MYC], and hypoxia-inducible factor-1alpha [HIF-1a]) in peripheral blood studies.
OUTLINE: This is a multicenter study.
Patients receive selumetinib orally (PO) twice daily (BID) 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01278615
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|Chicago, Illinois, United States, 60611|
|Decatur Memorial Hospital|
|Decatur, Illinois, United States, 62526|
|NorthShore University HealthSystem-Evanston Hospital|
|Evanston, Illinois, United States, 60201|
|Ingalls Memorial Hospital|
|Harvey, Illinois, United States, 60426|
|Peoria, Illinois, United States, 61615|
|Southern Illinois University|
|Springfield, Illinois, United States, 62702|
|United States, Indiana|
|Fort Wayne Medical Oncology and Hematology Inc-Parkview|
|Fort Wayne, Indiana, United States, 46845|
|Indiana University Medical Center|
|Indianapolis, Indiana, United States, 46202|
|United States, Maryland|
|University of Maryland/Greenebaum Cancer Center|
|Baltimore, Maryland, United States, 21201|
|United States, Massachusetts|
|Tufts Medical Center|
|Boston, Massachusetts, United States, 02111|
|University of Massachusetts Memorial Health Care|
|Worcester, Massachusetts, United States, 01605|
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|United States, Missouri|
|Saint John's Mercy Medical Center|
|Saint Louis, Missouri, United States, 63141|
|United States, New York|
|Weill Medical College of Cornell University|
|New York, New York, United States, 10065|
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Leo Gordon||University of Chicago|