This phase II trial is studying how well Akt inhibitor MK2206 works in treating patients with relapsed or refractory diffuse large B-cell lymphoma. Akt inhibitor MK2206 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES: I. To evaluate the antitumor activity of Akt inhibitor MK2206 (MK2206) in terms of objective response rate (ORR) at 4 months (complete response \[CR\], and partial response \[PR\]) as per the 2007 International Cheson response criteria. SECONDARY OBJECTIVES: I. To evaluate the antitumor activity of MK2206 in terms of ORR at 4 months (CR, unconfirmed complete response \[CRu\], and PR) as per the 1999 International Cheson response criteria. II. To determine the duration of response, defined as the time from the date of the best response to the date of progression. III. To determine the progression-free survival and overall survival of these patients. IV. To determine the safety of MK2206. V. To identify predictive biomarkers for treatment outcome. (exploratory) VI. To conduct a pharmacodynamic study using FDG-PET scans. (exploratory) OUTLINE: This a multicenter study. Patients receive Akt inhibitor MK2206 orally (PO) once weekly on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Given PO
Correlative studies
Correlative studies
Hopitaux de Paris
Vellefaux, Paris, France
Institut Bergonie Cancer Center
Bordeaux, France
Henri Mondor University-Hospital Center
Créteil, France
Hospital Claude Huriez Chru
Lille, France
Objective Response Rate According to the International Response Criteria for DLBCL (Cheson 2007)
Rate of CR + PR according to Cheson 2007 after 4 months of treatment
Time frame: Up to 4 months
Duration of Response
Described in responding subjects using descriptive statistics (median, extreme values, etc.).
Time frame: up to 4 years
Overall Survival
Analyzed using the Kaplan-Meier method. The median survival rates will be reported with a 95% confidence interval. Median follow-up will be calculated using the reverse Kaplan-Meier method.
Time frame: From the date of inclusion to the date of death from any cause, assessed up to 4 years
Progression-free Survival (PFS)
Analyzed using the Kaplan-Meier method. The median survival rates will be reported with a 95% confidence interval. Median follow-up will be calculated using the reverse Kaplan-Meier method.
Time frame: From the date of inclusion to the date of first documented disease progression, relapse or death from any cause, assessed up to 4 years
Toxicity as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Time frame: Up to 30 days
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Centre Leon Berard
Lyon, France
Institut Paoli Calmettes
Marseille, France
Hopital Saint Louis
Paris, France
Centre Hospitalier Lyon-Sud
Pierre-Bénite, France
Institut Gustave Roussy
Villejuif, France