Akt Inhibitor MK2206 in Treating Patients With Progressive, Recurrent, or Metastatic Adenoid Cyst Carcinoma

Completed · Phase 2

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT01604772

Run by

National Cancer Institute (NCI)

People needed

16

Starts

2012-07-23

Expected to finish

2014-11-22

Last updated by the study team

2019-05-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Christiana Care Health System-Christiana Hospital — Newark, Delaware, United States
• Baptist MD Anderson Cancer Center — Jacksonville, Florida, United States
• Mayo Clinic in Florida — Jacksonville, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
• Franciscan Health Indianapolis — Indianapolis, Indiana, United States
• Reid Health — Richmond, Indiana, United States
• Siouxland Regional Cancer Center — Sioux City, Iowa, United States
• Mercy Medical Center-Sioux City — Sioux City, Iowa, United States
• Saint Luke's Regional Medical Center — Sioux City, Iowa, United States
• Union Hospital of Cecil County — Elkton, Maryland, United States
• Fairview Ridges Hospital — Burnsville, Minnesota, United States
• Mercy Hospital — Coon Rapids, Minnesota, United States
• Fairview-Southdale Hospital — Edina, Minnesota, United States
• Unity Hospital — Fridley, Minnesota, United States
• Hutchinson Area Health Care — Hutchinson, Minnesota, United States
• Minnesota Oncology Hematology PA-Maplewood — Maplewood, Minnesota, United States
• Saint John's Hospital - Healtheast — Maplewood, Minnesota, United States
• Abbott-Northwestern Hospital — Minneapolis, Minnesota, United States
• Hennepin County Medical Center — Minneapolis, Minnesota, United States
• North Memorial Medical Health Center — Robbinsdale, Minnesota, United States
• Metro Minnesota Community Oncology Research Consortium — Saint Louis Park, Minnesota, United States
• Park Nicollet Clinic - Saint Louis Park — Saint Louis Park, Minnesota, United States
• Regions Hospital — Saint Paul, Minnesota, United States
• Beebe Medical Center — Lewes, Delaware, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.