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A Phase II Study of the HSP Inhibitor STA-9090 in Metastatic Ocular Melanoma

Phase 2
18 Years
Open (Enrolling)
Ocular Melanoma

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Trial Information

A Phase II Study of the HSP Inhibitor STA-9090 in Metastatic Ocular Melanoma

- Participants will receive STA-9090 intravenously over 1 hour once a week for the first
three weeks of a 4 week cycle (days 1, 8 and 15).

- During the first cycle (Cycle 1) participants will have the following tests and
procedures performed at the time point indicated: Day 1 and Day 15: clinical exam,
vital signs, ECG and blood tests. Day 2: Biopsy of tumor and blood tests. Day 8:
clinical exam, vital signs and blood tests. Days 16-18: PET scan.

- On Day 1 of all subsequent even cycles (4, 6, 8, etc.) the following tests and
procedures will be performed: clinical exam, vital signs, ECG, blood tests and urine
sample. On days 8 and 15 of all subsequent even cycles the following tests and
procedures will be performed: clinical exam, vital signs and blood tests. On days
22-28 of all even cycles and assessment of the tumor will also be performed.

- On Day 1 of all subsequent odd cycles (3, 5, 7, etc.) the following tests and
procedures will be performed: clinical exam, vital signs and blood tests.

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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival Rate

Outcome Description:

To determine the proportion of patients alive, free of disease progression, and still taking STA-9090 at 4 months.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

F. Stephen Hodi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

June 2010

Completion Date:

December 2013

Related Keywords:

  • Ocular Melanoma
  • STA9090
  • STA-9090
  • HSP90
  • Melanoma



Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617