Dosing Study of Amino Acids in Seriously Ill Patients

Determination of the Optimal Infusion Rate of Amino Acids in Seriously Ill Patients

The purpose of this study is to determine the best rate of infusion of amino acids (15% CLINISOL - sulfite-free (Amino Acid) Injection) for nutrition in subjects with with stages II to IVB head and neck cancer.

Inclusion Criteria:

• Have Stages II to IVB head and neck cancer receiving radiation and may also be receiving chemotherapy.

  * Subjects are eligible for inclusion in the study regardless of primary Stages II to IVB head and neck cancer treatment modality (eg, surgery, chemotherapy).

• Have voluntarily signed and dated a written informed consent form (ICF) after the nature of the study was explained to them.

• Female subjects must be of non childbearing potential (defined as postmenopausal for at least 1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy or hysterectomy]) or;

• Female subjects of childbearing potential must be using adequate contraception (practicing 1 of the following methods of birth control):

  • total abstinence from sexual intercourse (minimum of 1 complete menstrual cycle before study entry),
  • a vasectomized partner,
  • contraceptives (oral, parenteral, or transdermal) for 3 consecutive months prior to study drug administration,
  • intrauterine device (IUD), or
  • double barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream).

• Female subjects must have a negative serum or urinary pregnancy test result at screening (serum specimen must be obtained within 14 days prior to baseline).

Exclusion Criteria:

• Had a loss of > 10% of body weight within the 3 month period prior to the study as noted in the subjects medical history chart.
• Have renal disease as determined by an estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2.
• Have a hemoglobin level of < 9 g/dl.
• Have Stage 0, I, or IVC metastatic cancer.
• Have diabetes.
• Have any reason which, in the opinion of the Investigator, would prevent the subject from safely participating in the study.
• Have, in the opinion of the Investigator, a dependence on alcohol.
• Have, in the opinion of the Investigator, a dependence on illicit drugs.