Phase II Study of MK-2206 in Patients with Relapsed Lymphoma
The goal of this clinical research study is to learn if MK-2206 can help to control Hodgkin's and non-Hodgkin’s lymphoma. The safety of this drug will also be studied.
Disease Group: Hematologic Disorder,Lymphoma
Treatment Agent: MK-2206
Treatment Location: Only at MD Anderson
Primary Objective : 1. Determine the objective response rate of MK-2206 in patients with relapsed/refractory lymphoma 2. Assess the safety and tolerability of MK-2206 monotherapy
IRB Review and Approval Date: 12/10/2010
Recruitment Status: Not Accepting
Projected Accrual: N/A
1) Histologically confirmed Hodgkin lymphoma (HL) or non Hodgkin’s
lymphoma (NHL) (Small lymphocytic lymphoma may be included)
2) Relapsed or refractory after at least one regimen and with no curative option with conventional therapy.
3) Bidimensionally measurable disease (at least 2 cm)
4) No evidence of cerebral or meningeal involvement by lymphoma
5) Age >/= 18 years
6) Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
7) Signed informed consent form prior to enrollment
8) The effects of MK-2206 on the developing human fetus at the recommended therapeutic dose are unknown. For this reason 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.
1) Burkitt’s lymphoma, Lymphoblastic lymphoma, Chronic lymphocytic
leukemia and cutaneous T-cell lymphoma
2) 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
3) Previous radioimmunotherapy within 12 weeks
4) Patients with known Human immunodeficiency virus (HIV) infection must not have CD4 cells <400/mm3 and who must not have a prior acquired immunodeficiency syndrome (AIDS)-defining diagnosis and can not be on antiretroviral therapy for HIV
5) Known active viral hepatitis
6) Any serious active disease or co-morbid condition, which in the opinion of the principle investigator, will interfere with the safety or with compliance with the study
7) Poor bone marrow reserve as defined by absolute neutrophil count < 1.5 x109/L or platelets < 75 x 109/L
8) Poor organ function as defined by one of the following: ? Total bilirubin > 1.5 x upper limit of normal (ULN) (>3 x ULN for patients with liver involvement) ?Aspartate transaminase (AST), Alanine transaminase (ALT) > 2.5 x ULN (> 5 x ULN for patients with liver involvement) ? Serum creatinine > 2 x ULN ? HbA1C>8%
9) Patients receiving any medications or substances that are inhibitors or inducers of CYP 450 3A4 are ineligible. Lists including medications and substances known or with the potential to interact with the CYP 450 3A4 isoenzymes.
10) Preclinical studies demonstrated the potential of MK-2206 for induction of hyperglycemia in all preclinical species tested. 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.
11) Preclinical studies indicated transient changes in QTc interval during MK-2206 treatment. Prolongation of QTc interval is potentially a safety concern while on MK-2206 therapy. Cardiovascular: baseline QTcF > 450 msec (male) or QTcF >470 msec (female) will exclude patients from entry on study. A list of medications that may cause QTc interval prolongation are listed and should be avoided by patients entering on trial.
12) Significant heart block or baseline bradycardia <50bpm due to cardiac disease
13) Patients who are pregnant or breastfeeding