STA-9090(Ganetespib) in Metastatic Ocular Melanoma
Condition: Ocular Melanoma
MeSH terms: Melanoma
Intervention: STA-9090
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: The original dose (Cohort A) was amended based on phase 1 data for safety. Therefore there are 2 separate arms reported.
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: STA9090; STA-9090; HSP90

Summary:

      STA-9090, a synthetic small molecule, demonstrates significant activity for down-regulating
      Heat Shock Protein 90 or Hsp90 levels. Hsp90 belongs to a class of molecular chaperone
      proteins known to be critical regulators of cancer cell proliferation and survival.
      Preclinical laboratory experiments have shown STA-9090, an Hsp90 inhibitor, could inhibit
      ocular melanoma cell lines. The primary objective of this trial is to obtain evaluations of
      STA-9090 efficacy to metastatic ocular melanoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed stage IV ocular melanoma

          -  ECOG Performance status 0, 1, or 2

          -  18 years of age or older

          -  Laboratory values as indicated in the protocol

          -  Women of child-bearing potential and men must agree to use adequate contraception
             prior to study entry and for the duration of study participation

          -  Presence of metastatic disease that would be amenable to the required biopsies

          -  At least one site of measurable disease as defined by at least 1cm in greatest
             dimension. This site must be different from the sites to be used for biopsy. No prior
             radiation therapy or directed ablation to the site of measurable disease

        Exclusion Criteria:

          -  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

          -  Major surgery within 4 weeks prior to first dose of STA-9090

          -  Minor surgery within 7 days of first dose of STA-9090

          -  Embolization procedure or ablation procedure to treat tumor within 4 weeks of first
             dose

          -  Participants may not be receiving any other investigational agents

          -  Poor venous access for study drug administration unless patient can use silicone based
             catheters

          -  History of brain metastases or of leptomeningeal involvement

          -  History of allergic reactions or hypersensitivity reactions attributed to compounds of
             similar chemical or biologic composition to STA-9090

          -  Baseline QTc > 450 msec or previous history of QT prolongation while taking other
             medications

          -  Ventricular ejection fraction (EF) of 55% or less at baseline

          -  Treatment with chronic immunosuppressants

          -  Melanoma of cutaneous, mucosal or acral-lentiginous origin or of unknown primary

          -  Prior treatment with HSP90 inhibitor

          -  Not willing to undergo biopsy before and after treatment

          -  Uncontrolled intercurrent illness including, but not limited to ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  Other medications, or severe acute/chronic medical or psychiatric conditions or
             laboratory abnormality that may increase the risk associated with the study
             participation or study drug administration, or may interfere with the interpretation
             of study results, and in the judgment of the investigator would make the participant
             inappropriate for entry into the study

          -  Pregnant or breastfeeding women

          -  Individual with a history of a different malignancy are ineligible except for
             circumstances outlined in the protocol

          -  HIV-positive individuals on combination antiretroviral therapy

          -  History of or current coronary artery disease, myocardial infarction, angina pectoris,
             angioplasty or coronary bypass surgery

          -  History of or current uncontrolled dysrhythmias, or requirement for antiarrhythmic
             medication, or Grade 2 or greater left bundle branch block

          -  NYHA class II/III/IV congestive heart failure with a history of dyspnea, orthopnea or
             edema that requires current treatment with angiotensin converting enzyme inhibitors,
             angiotensin II receptor blockers, beta-blockers or diuretics

          -  Current or prior radiation therapy to the left hemithorax