This trial is active, not recruiting.

Conditions adult nasal type extranodal nk/t-cell lymphoma, anaplastic large cell lymphoma, angioimmunoblastic t-cell lymphoma, b-cell adult acute lymphoblastic leukemia, b-cell chronic lymphocytic leukemia, cutaneous b-cell non-hodgkin lymphoma, extranodal marginal zone b-cell lymphoma of mucosa-associated lymphoid tissue, hepatosplenic t-cell lymphoma, intraocular lymphoma, nodal marginal zone b-cell lymphoma, noncutaneous extranodal lymphoma, peripheral t-cell lymphoma, recurrent adult acute lymphoblastic leukemia, recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult grade iii lymphomatoid granulomatosis, recurrent adult hodgkin lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent adult t-cell leukemia/lymphoma, recurrent cutaneous t-cell non-hodgkin lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent mantle cell lymphoma, recurrent marginal zone lymphoma, recurrent mycosis fungoides/sezary syndrome, recurrent small lymphocytic lymphoma, refractory hairy cell leukemia, small intestine lymphoma, splenic marginal zone lymphoma, t-cell adult acute lymphoblastic leukemia, t-cell large granular lymphocyte leukemia, testicular lymphoma, waldenström macroglobulinemia
Treatments akt inhibitor mk2206, laboratory biomarker analysis
Phase phase 2
Sponsor National Cancer Institute (NCI)
Start date December 2010
End date July 2014
Trial size 60 participants
Trial identifier NCT01258998, 2010‐0261, 8728, N01CM00039, N01CM62202, NCI-2011-00275, NCI-2012-02890, P30CA016672


This phase II clinical trial studies how well Akt inhibitor MK2206 works in treating patients with relapsed lymphoma. Akt inhibitor MK2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Patients receive Akt inhibitor MK2206 PO once weekly. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
akt inhibitor mk2206 MK2206
Given PO
laboratory biomarker analysis
Correlative studies

Primary Outcomes

time frame: 4 months

Secondary Outcomes

Progression-free survival
time frame: From start of treatment to time of progression or death, whichever occurs first, assessed up to 30 days
Duration of response
time frame: From the time measurement criteria are met for complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 30 days
Overall survival
time frame: Up to 30 days
Change in cytokine levels
time frame: Baseline to up to 30 days post-treatment
Change in chemokine levels
time frame: Baseline to up to 30 days post-treatment
Change in biomarker levels of interest (Akt, pAKT, and apoptosis [annexin-V])
time frame: Baseline to up to 30 days post-treatment
Incidence of adverse events as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
time frame: Up to 30 days

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Histologically confirmed Hodgkin lymphoma (HL) or non-Hodgkin lymphoma (NHL) (small lymphocytic lymphoma may be included) - Relapsed or refractory after at least one regimen and with no curative option with conventional therapy - Bidimensionally measurable disease (at least 2 cm) - No evidence of cerebral or meningeal involvement by lymphoma - Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 - Signed informed consent form prior to enrollment - Women of childbearing potential and men must use two forms of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a women become pregnant or suspect she is pregnant while she or her partner is participating in this study, the patient should inform the treating physician immediately Exclusion Criteria: - Burkitt's lymphoma, lymphoblastic lymphoma, chronic lymphocytic leukemia and cutaneous T-cell lymphoma - Chemotherapy or radiation therapy or other investigational agents within 3 weeks prior to entering the study unless there is clear evidence of progression of disease and toxicity from previous treatment has resolved in which case study entry may be within 1 week of last treatment - Previous radioimmunotherapy within 12 weeks - Patients with known immunodeficiency virus (HIV) infection must not have cluster of differentiation (CD)4 cells < 400/mm^3 and who must not have a prior acquired immunodeficiency syndrome (AIDS)-defining diagnosis and cannot be on antiretroviral therapy for HIV - Known active viral hepatitis - Any serious active disease or co-morbid condition, which in the opinion of the principal investigator, will interfere with the safety or with compliance with the study - Absolute neutrophil count < 1.5 x 10^9/L - Platelets < 75 x 10^9/L - Total bilirubin > 1.5 x upper limit of normal (ULN) (> 3 x ULN for patients with liver involvement) - Aspartate aminotransferase (AST), alanine aminotransferase (ALT) > 2.5 x ULN (> 5 x ULN for patients with liver involvement) - Serum creatinine > 2 x ULN - Hemoglobin (Hb)A1C > 8% - Patients receiving any medications or substances that are inhibitors of cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP 450 3A4) are ineligible - Patients with diabetes or in risk for hyperglycemia should not be excluded from trials with MK-2206, but the hyperglycemia should be well controlled on oral agents before the patient enters the trial - Cardiovascular: baseline Fredericia corrected QT interval (QTcF) > 450 msec (male) or QTcF > 470 msec (female) will exclude patients from entry on study - Significant heart block or baseline bradycardia < 50 beats per minute (bpm) due to cardiac disease - Patients who are pregnant or breastfeeding

Additional Information

Official title Phase II Study of MK-2206 in Patients With Relapsed Lymphoma
Principal investigator Yasuhiro Oki
Description PRIMARY OBJECTIVES: I. Determine the objective response rate (ORR) of MK-2206 (Akt inhibitor MK2206) in patients with relapsed/refractory lymphoma. SECONDARY OBJECTIVES: I. Assess the progression free survival (PFS) of MK-2206 in patients with relapsed/refractory lymphoma. II. Assess the safety and tolerability of MK-2206 monotherapy. III. Examine pretreatment phosphorylated v-akt murine thymoma viral oncogene homolog 1 (pAkt) protein expression by immunohistochemistry, and correlate the results with treatment response. IV. Examine the effect of therapy on serum cytokines and chemokines that regulate the tumor-promoting inflammatory process and/or immunity in patients with relapsed/refractory lymphoma, and correlate the results with treatment response. OUTLINE: Patients receive Akt inhibitor MK2206 orally (PO) once weekly. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days.
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).