Akt Inhibitor MK2206 in Treating Patients With Progressive, Recurrent, or Metastatic Adenoid Cyst Carcinoma
Condition: Recurrent Oral Cavity Adenoid Cystic Carcinoma; Recurrent Salivary Gland Carcinoma; Salivary Gland Adenoid Cystic Carcinoma; Stage IVA Major Salivary Gland Cancer AJCC v7; Stage IVA Oral Cavity Adenoid Cystic Carcinoma AJCC v6 and v7; Stage IVB Major Salivary Gland Cancer AJCC v7; Stage IVB Oral Cavity Adenoid Cystic Carcinoma AJCC v6 and v7; Stage IVC Major Salivary Gland Cancer AJCC v7; Stage IVC Oral Cavity Adenoid Cystic Carcinoma AJCC v6 and v7
MeSH terms: Carcinoma; Salivary Gland Neoplasms; Carcinoma, Adenoid Cystic; Recurrence
Intervention: Akt Inhibitor MK2206; Laboratory Biomarker Analysis
Intervention description: Given PO; Correlative studies
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well Akt inhibitor MK2206 works in treating patients with
      progressive, recurrent, or metastatic adenoid cyst carcinoma (cancer). Akt inhibitor MK2206
      may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have pathologically confirmed adenoid cystic carcinoma; confirmation
             will be performed locally at each participating institution; cancers arising from
             non-salivary gland primary sites are allowed

          -  Patients must have measurable disease, as at least one lesion that can be accurately
             measured in at least one dimension (longest diameter to be recorded for non-nodal
             lesions and short axis for nodal lesions) as >= 2.0 cm with conventional techniques or
             as >= 1.0 cm with spiral computed tomography (CT) scan; to be considered
             pathologically enlarged and measurable, a lymph node must be > 1.5 cm in short axis
             when assessed by CT scan (CT scan slice-thickness recommended to be no greater than 5
             mm)

          -  Patients must have locally advanced and/or recurrent and/or metastatic disease not
             amenable to potentially curative surgery or radiotherapy

          -  Patients must have increasing disease, defined as the presence of new or progressive
             lesion(s) on CT/magnetic resonance imaging (MRI) within 6 months prior to study
             enrollment and/or new/worsening disease-related symptoms; NOTE: this increase in
             disease is to be determined in the oncologist's best judgment and does not have to
             meet Response Evaluation Criteria in Solid Tumors (RECIST) criteria

          -  Chemotherapy and radiation therapy must be completed at least 4 weeks prior to
             registration; if the last regimen included Carmustine (BCNU) or mitomycin C, it must
             be completed at least 6 weeks prior to registration; NOTE: any number of prior
             chemotherapy regimens is allowed, including no prior treatment

          -  Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (equivalent to
             Karnofsky >= 50%)

          -  Leukocytes >= 3,000/mm^3

          -  Absolute neutrophil count >= 1,000/mm^3

          -  Platelets >= 75,000/mm^3

          -  Total bilirubin =< institutional upper limit of normal (ULN)

          -  Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or
             serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 2.5
             institutional upper limit of normal

          -  Creatinine =< ULN OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with
             creatinine levels above ULN

          -  Patients must be able to swallow whole tablets; NOTE: nasogastric or gastric (G) tube
             administration is not allowed; tablets must not be crushed or chewed

          -  Patients must have the ability to understand and the willingness to sign a written
             informed consent document

        Exclusion Criteria:

          -  Patients who have received prior treatment with phosphatidylinositol-4,5-bisphosphate
             3-kinase, catalytic subunit alpha (PI3K), v-akt murine thymoma viral oncogene homolog
             1 (Akt), or mechanistic target of rapamycin (serine/threonine kinase) (mTOR)
             inhibitors for recurrent/metastatic ACC

          -  Patients who are receiving any other investigational agents

          -  Patients with known brain metastases

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to MK-2206 or other agents used in the study

          -  Patients receiving any medications or substances that are major inhibitors or inducers
             of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP450 3A4)

          -  Diabetic patients with glycated hemoglobin (HbA1c) levels of greater than 8%; NOTE:
             preclinical studies demonstrated the potential of MK-2206 for induction of
             hyperglycemia in all preclinical species tested; patients with diabetes or at risk for
             hyperglycemia should not be excluded from trials with MK-2206, but the hyperglycemia
             should be well controlled before the patient enters the trial

          -  Cardiovascular baseline Fridericia corrected QT (QTcF) > 450 msec (male) or QTcF > 470
             msec (female) will exclude patients from entry on study; NOTE: medications that may
             cause QTc interval prolongation should be avoided by patients entering on trial

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that, in the opinion of the
             investigator, would limit compliance with study requirements

          -  Pregnant women; NOTE: women of child-bearing potential must have a negative serum or
             urine pregnancy test within 7 days prior to registration

               -  Women of child-bearing potential and men must agree to use adequate contraception
                  (hormonal or barrier method of birth control; abstinence) prior to study entry
                  and for the duration of study participation; should a woman become pregnant or
                  suspect she is pregnant while she or her partner is participating in this study,
                  she should inform her treating physician immediately

               -  Breastfeeding should be discontinued if the mother is treated with MK-2206

          -  Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral
             therapy

          -  Other active malignancy, other than indolent malignancies which the investigator
             determines are unlikely to interfere with treatment and safety analysis