Clinical trial NCT01191216 (phase 1, status: completed)
Conditions: unspecified adult solid tumor, protocol specific
ICD codes: H01.009, H02.209, H02.009, H02.109, H04.209, H05.409, H10.509
Drugs: 1-methyl-d-tryptophan, docetaxel
SMILES: CN1C=C(C[C@@H](N)C(O)=O)C2=CC=CC=C12, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically or cytologically confirmed metastatic solid
             malignancy

               -  Preference will be given to patients whose malignancies are treated with
                  docetaxel as part of routine therapy

          -  Patients must have measurable disease, defined as at least one lesion that can be
             accurately measured in at least one dimension (longest diameter to be recorded) as ≥
             20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan

          -  Patients with known brain metastases will only be eligible after their tumors have
             been treated with definitive resection and/or radiotherapy and they are neurologically
             stable for at least 1 month off steroids

          -  ECOG performance status ≤ 2 (Karnofsky ≥ 60%)

          -  Life expectancy of greater than 4 months

          -  Leukocytes ≥ 3,000/μL

          -  Absolute neutrophil count ≥ 1,500/μL

          -  Platelets ≥ 100,000/μL

          -  Total bilirubin normal

          -  AST/ALT ≤ 1.5 times upper limit of normal

          -  Creatinine normal OR creatinine clearance ≥ 60 mL/min

          -  Negative pregnancy test

          -  Not pregnant or nursing

          -  Sexually active women of child-bearing potential must agree to use two forms of
             contraception (hormonal and barrier method of birth control or abstinence) prior to
             study entry, for the duration of study participation, and for a minimum of 1 month
             after completion of the study; men should be discouraged from fathering children while
             on treatment

          -  No history of gastrointestinal disease causing malabsorption or obstruction such as,
             but not limited to, Crohn's disease, celiac sprue, tropical sprue, bacterial
             overgrowth/blind loop syndrome, gastric bypass surgery, strictures, adhesions,
             achalasia, bowel obstruction, or extensive small bowel resection

          -  No patients with any active autoimmune disease (i.e., psoriasis, extensive atopic
             dermatitis, asthma, IBD, M.S., uveitis, vasculitis), chronic inflammatory condition,
             or any condition requiring concurrent use of any systemic immunosuppressants or
             steroids for any reason

               -  Mild-intermittent asthma requiring ONLY occasional beta-agonist inhaler use or
                  mild localized eczema allowed

          -  No uncontrolled concurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, myocardial
             infarction or percutaneous coronary interventions within the last 6 months, cardiac
             arrhythmia, active autoimmune diseases, or major psychiatric illness/social situations
             that would limit compliance with study requirements as judged by the primary
             investigator at each site

               -  Patients with well-controlled, chronic medical conditions under the supervision
                  of the patient's primary physician (i.e., hypertension, hyperlipidemia, coronary
                  heart disease, diabetes mellitus) are eligible

          -  No HIV-positive patients or those with other acquired/inherited immunodeficiencies

          -  No patients with more than one active malignancy at the time of enrollment

          -  No history of allergic reactions (significant urticaria, angioedema, anaphylaxis)
             attributed to compounds of similar chemical or biologic composition to
             1-methyl-d-tryptophan (this wouldi nclude L-tryptophan or 5-hydroxy-tryptophan
             supplements) or history of severe hypersensitivity reactions to docetaxel or to other
             drugs formulated with polysorbate 80

          -  No patients with an allo-transplant of any kind (this would include those with a
             xenograft heart valve)

          -  No prior treatment with experimental systemic immunotherapies such as CTLA-4 mAb (with
             the exception of vaccines)

          -  No patients who have received any prior experimental active immunotherapy consisting
             of targeted monoclonal antibodies or pharmaceutical compounds

               -  Patients who have received prior experimental vaccine may be enrolled if approved
                  by the PI

               -  Patients who have received commercially available active immunotherapies such as
                  adjuvant interferon must have completed therapy over 1 year prior to enrollment
                  and have no evidence of autoimmune sequelae

               -  Prior therapy with approved monoclonal antibodies such as bevacizumab, cetuximab,
                  panitumumab, or trastuzumab allowed

          -  No patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
             nitrosoureas or mitomycin C) prior to entering the study or those who have not
             recovered from adverse events due to agents administered more than 4 weeks earlier

          -  Patients may not have received docetaxel in the metastatic setting previously, but are
             eligible for the trial if they received docetaxel in the adjuvant setting and at least
             one year elapsed between completion of adjuvant chemotherapy and disease recurrence

          -  Patients may have received any number of prior chemotherapy treatments

          -  Patients may not be concomitantly receiving any other investigational agents or
             standard therapies with the intent of treating their malignancy while on study

          -  No supplements containing L-tryptophan or derivatives there of are allowed to be taken
             while on study