IDO Inhibitor Study for Relapsed or Refractory Solid Tumors

Inclusion Criteria:

• A histological or cytological diagnosis of recurrent or refractory solid tumormalignancy. The patient's pathology must be reviewed and confirmed prior to enrollment (outside reviews acceptable). If no standard therapy exists for disease or subjectrefused standard therapy, subject would be considered eligible for enrollment.

• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.

• Hemoglobin ≥ 9.0 gm/dL, absolute neutrophil count (ANC) ≥1200/mm3, platelets ≥100,000/mm3, absolute lymphocyte count ≥800/mm3.

• Hepatic: serum total bilirubin ≤ 1.5 x ULN mg/dL, ALT (SGPT) and AST (SGOT) ≤2.5 xupper limit of normal (ULN).

• Renal: serum creatinine (sCr) ≤1.5 x ULN, or creatinine clearance (Ccr) ≥50 mL/min (approximation by Cockcroft and Gault accepted)

• Life expectancy of greater than 4 months.

• Measurable or non-measurable disease

• Normal EKG including benign variants or abnormalities associated with any conditioncurrently responding to appropriate care (e.g., controlled hypertension with minimalor moderate LVH, controlled AF).

• Prior therapy may include any number of chemotherapy, immunotherapy, and/or radiationtherapy regimens. Major surgery or systemic chemotherapy must have been completed atleast 4 weeks prior to enrollment and residual toxicities from that therapy must beGrade 1 or lower at the time of enrollment with the exception of hemoglobin andabsolute granulocyte count. Localized radiation therapy must have been completed atleast 2 weeks prior to enrollment and residual toxicities must be Grade 1 or lower atthe time of enrollment.

• Patients must have the ability to understand the study, its inherent risks, sideeffects and potential benefits and be able to give written informed consent toparticipate.

• Male and female subjects of child producing potential must agree to use contraceptionor avoidance of pregnancy measures while enrolled on study and receiving theexperimental drug, and for one month after the last dose of drug.

• Patients must be at least 18 years of age

Exclusion Criteria:

• Active CNS metastases or carcinomatous meningitis. Patients with CNS metastases mustbe at least 3 months status post of prior therapy to the brain and be off all steroidswithout progressing CNS disease.

• Pregnant or nursing women due to the unknown effects of study drug on the developingfetus or newborn infant.

• History of gastrointestinal disease causing malabsorption or obstruction such as butnot limited to Crohn's disease, celiac sprue, tropical sprue, bacterialovergrowth/blind loop syndrome, gastric bypass surgery, strictures, adhesions,achalasia, bowel obstruction, or extensive small bowel resection.

• History of organ transplant.

• Subjects with autoimmune disease, either active or by history (e.g., systemic lupuserythematosis (SLE), rheumatoid arthritis (RA), scleroderma, dermatomyositis, etc.).

• Subjects receiving immunosuppressive therapy including systemic corticosteroid therapyand/other immunosuppressive therapy (methotrexate, cyclosporine, FK-506, rapamycin)for any reason. Subjects receiving inhaled or topical corticosteroids are eligible.

• Significant or uncontrolled cardiovascular disease to include: uncontrolledhypertension (blood pressure must be ≤ 150/90 mmHg at the time of enrollment on astable antihypertensive regimen); New York Heart Association grade II or greatercongestive heart failure (CHF); grade II or greater peripheral vascular disease;significant ventricular arrhythmias requiring medication; and myocardial infarction orunstable angina < six months prior to enrollment.

• Active uncontrolled infection requiring antibiotics within 1-week prior to study,including unexplained fever (temp > 38.1°C or >100.6°F).

• Any condition, psychiatric or otherwise, that would preclude informed consent,consistent follow-up or compliance with any aspect of the study (e.g., untreatedschizophrenia or other significant cognitive impairment, etc.).

• No supplements containing L-trytophan or derivatives thereof are allowed to be takenwhile on study.

• Patients with positive serology for HIV, Hepatitis B or C, and patients with otheracquired/inherited immunodeficiencies are ineligible due to the possibility ofaffecting the response to D-1MT and the higher risk of active opportunisticinfections.

• Patients with more than one active malignancy at the time of enrollment.