Clinical trial NCT00087386 (phase 2, status: terminated)
Conditions: recurrent melanoma, stage iii melanoma, stage iv melanoma
ICD codes: G47.13, J01.41, K11.22, K12.0, N96, F33.8, G03.2, C43.0, C43.31, D03.9, C43.51, C43.9, D03.0, C43.4, C43.0, C43.31, D03.9, C43.51, C43.9, D03.0, C43.4
Drugs: tanespimycin
SMILES: [H]/C1=C([H])/[C@]([H])(OC)[C@@]([H])(OC(O)=N)C(C)=C([H])[C@]([H])(C)[C@@]([H])(O)[C@]([H])(C[C@]([H])(C)CC2=C(NCC=C)C(=O)C=C(N=C(O)\C(C)=C\1/[H])C2=O)OC
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed melanoma

               -  Stage III or IV disease

          -  No primary melanoma of the choroid or mucosa

          -  Measurable disease

               -  At least 1 unidimensionally measurable lesion >= 20 mm by conventional techniques
                  OR >= 10 mm by spiral CT scan

          -  Tumor amenable to biopsy (for the first 10 patients in each stratum only)

               -  Patients must have measurable disease in addition to the tumor(s) to be biopsied

          -  No brain or epidural metastases

               -  Completely resected solitary brain metastases allowed provided patient has been
                  free of CNS metastases for >= 6 months

          -  Performance status - Karnofsky 60-100%

          -  Performance status - ECOG 0-2

          -  More than 3 months

          -  Absolute neutrophil count >= 1,500/mm^3

          -  Platelet count >= 100,000/mm^3

          -  WBC >= 3,000/mm^3

          -  AST and ALT =< 2.5 times upper limit of normal

          -  Creatinine normal

          -  No symptomatic congestive heart failure

          -  No unstable angina pectoris

          -  No cardiac arrhythmia

          -  No history of myocardial infarction

          -  No history of prolonged QTc interval

          -  No active ischemic heart disease within the past 12 months

          -  No uncontrolled dysrhythmia or dysrhythmias requiring medication

          -  No congenital prolonged QT syndrome

          -  No left bundle branch block

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No prior allergic reaction attributed to compounds of similar chemical or biological
             composition to 17-N-allylamino-17-demethoxygeldanamycin (17-AAG)

          -  No prior serious allergic reaction to eggs

          -  No other uncontrolled illness

          -  No active or ongoing infection requiring systemic antimicrobial treatment

          -  No psychiatric illness or social situation that would preclude study compliance

          -  No more than 1 prior chemotherapy regimen for metastatic melanoma

               -  Prior vaccines, cytokines, or interferon alfa is not considered prior therapy
                  unless administered with a chemotherapy drug

          -  More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and
             recovered

          -  Prior radiotherapy dose =< 3,000 cGy to fields including substantial marrow

          -  More than 4 weeks since prior radiotherapy and recovered

          -  No prior radiotherapy field that included the heart (e.g., mantle)

          -  No concurrent combination antiretroviral therapy for HIV-positive patients

          -  No concurrent medications that may prolong the QTc interval

          -  No other concurrent anticancer therapy

          -  No other concurrent investigational agents

          -  No concurrent treatment with any of the following medications or herbal remedies:

               -  Inhibitors of CYP3A4:

                    -  Fluconazole

                    -  Itraconazole

                    -  Ketoconazole

                    -  Macrolide antibiotics (azithromycin, clarithromycin, erythromycin, or
                       troleandomycin)

                    -  Midazolam

                    -  Nifedipine

                    -  Verapamil

                    -  Diltiazem

                    -  Terfenadine

                    -  Cyclosporine

                    -  Cisapride

               -  Inducers of CYP3A4:

                    -  Carbamazepine

                    -  Phenobarbital

                    -  Phenytoin

                    -  Rifampin

               -  Herbal extracts and tinctures with CYP3A4 inhibitory activity:

                    -  Hydrastis canadensis (goldenseal)

                    -  Hypericum perforatum (St. John's wort)

                    -  Uncaria tomentosa (cat's claw)

                    -  Echinacea angustifolia roots

                    -  Trifolium pratense (wild cherry)

                    -  Matricaria chamomilla (chamomile)

                    -  Glycyrrhiza glabra (licorice)

                    -  Dillapiol

                    -  Hypericin

                    -  Naringin

          -  No other concurrent herbal extracts