Clinical trial NCT00661336 (phase 1, status: withdrawn)
Conditions: melanoma (skin)
ICD codes: C43.51, C43.9, C43.52, D03.51, C43.8, Z85.820, D03.52
Drugs: buthionine sulfoximine, melphalan
SMILES: CCCCS(=N)(=O)CCC(N)C(O)=O, N[C@@H](CC1=CC=C(C=C1)N(CCCl)CCCl)C(O)=O
Reason stopped: 
    the study was withdrawn due to lack of patients.
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically proven primary or recurrent in-transit melanoma of the extremity

               -  Stage IIIB or IIIC disease, as determined by whole body imaging with a CT scan of
                  the chest, abdomen, and pelvis AND PET scan within the past 4 weeks

                    -  Patients with stage IIIC disease must have undergone removal of regional
                       lymph nodes

                    -  Patients with indeterminate staging must be reviewed by the study chairs
                       prior to study registration

          -  Previously treated with melphalan-based regional therapy and had persistent disease at
             3 months OR achieved a complete response but disease recurred within 6 months

          -  Disease to be treated by regional therapy must be distal to the planned site of
             tourniquet placement

          -  Bidimensionally measurable disease by caliper or a radiological method as defined by
             the RECIST criteria modified for cutaneous lesions

               -  Photo documentation required

               -  Patients with a single lesion must have archived tumor tissue available for study
                  analysis

          -  No history of tumors with clinically significant evidence of active bleeding (e.g.,
             gross hemoptysis, hematemesis, hematuria, melena, or bleeding superficial tumor)
             within the past 12 weeks

          -  No stage IV disease

          -  No cerebral metastases

        PATIENT CHARACTERISTICS:

          -  ECOG/Zubrod performance status 0-1

          -  Serum creatinine ≤ 1.5 mg/dL

          -  WBC ≥ 3,000/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Hemoglobin ≥ 10 g/dL

          -  Bilirubin normal

          -  AST and ALT ≤ 2.5 times normal

          -  Must have a palpable femoral/axillary pulse in the affected extremity

          -  No uncontrolled seizures or clinically significant CNS disorders

          -  No psychiatric condition or diminished capacity that could preclude study compliance
             or giving informed consent

          -  No history of allergic reactions and/or hypersensitivity to melphalan

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No history of other malignancies except adequately treated basal cell or squamous cell
             carcinoma of the skin; curatively treated carcinoma in situ of the uterine cervix,
             prostate cancer, or superficial bladder cancer; or other curatively treated solid
             tumors with no evidence of disease for ≥ 5 years

          -  No stroke or other major tissue injury within the past 4 weeks

          -  No other uncontrolled serious chronic disease or condition that, in the investigator's
             opinion, could preclude study compliance or follow-up

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  Recovered from prior therapy

          -  More than 4 weeks since prior major surgery

               -  Wound healing adequate since last major surgery

          -  More than 4 weeks since prior antineoplastic therapy, radiotherapy, or any other
             investigational drug

          -  More than 7 days since prior antimicrobial agents (i.e., antibiotic, antifungal, or
             antiviral agents) for active infection or infectious symptoms

          -  No drugs that are known to cause enhanced glutathione depletion (e.g., acetaminophen)
             for 7 days before, during, and for 7 days after buthionine sulfoximine (BSO)
             administration

          -  No cephalosporin antibiotics for 7 days before, during, and for 7 days after BSO
             administration