Statement: The Maximum Tolerated Dose (MTD) of of 1-methyl-d-tryptophan (indoximod) observed in the primary trial was 800 mg.
Primary_evidence: Outcome Measurement:    Phase 1 - Maximum Tolerated Dose (MTD) in Milligrams (mg)   MTD of 1-methyl-d-tryptophan (indoximod) given by mouth (PO), twice a day (BID), with up to 6 fixed doses Ad.p53 DC vaccinations every 2 weeks (q2wks). This phase 1 study used a 3+3 design with 7 indoximod dose levels (DL) (100 mg, 200 mg, 400 mg, 800 mg daily (QD) then 800 mg, 1,200 mg, and 1,600 mg PO BID +up to 6 fixed dose Ad.p53 DC vaccinations q2wks. Toxicity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0. The MTD is the highest dose level below the maximally administered dose (MAD) that is safely tolerated among 6 treated patients, that is, 0 or 1 out of 6 patients experiences a dose limiting toxicity (DLT).   Time frame: Up to 4 weeks Results 1:    Arm/Group Title: Treatment (Vaccine Therapy, 1-methyl-d-tryptophan)   Arm/Group Description: Participants receive adenovirus-p53 transduced dendritic cell (Ad.p53-DC) vaccine ID in weeks 1, 3, 5, and 10, and then every 3 weeks for 6 total doses. Participants also receive 1-methyl-d-tryptophan (indoximod) orally (PO) daily (QD) on days 1-21. Treatment with 1-methyl-d-tryptophan repeats every 28 days (patients with stable disease) for up to 12 courses in the absence of disease progression or unacceptable toxicity.   adenovirus-p53 transduced dendritic cell (DC) vaccine: Given intradermally (ID)   1-methyl-d-tryptophan: Given orally (PO)   Laboratory biomarker analysis: Correlative studies   Overall Number of Participants Analyzed: 30   Measure Type: Number   Unit of Measure: indoximod dose in mg  1600