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STA-9090(Ganetespib) in Metastatic Ocular Melanoma

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01200238
First Posted: September 13, 2010
Last Update Posted: January 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Brigham and Women's Hospital
Synta Pharmaceuticals Corp.
Information provided by (Responsible Party):
F. Stephen Hodi, MD, Dana-Farber Cancer Institute
  Purpose
STA-9090 is drug which inactivates or blocks the work of a protein called Heat Shock Protein 90 or HSP90. HSP90 is a protein that helps some molecules inside the cells have the right shape. By stopping it's activity, these molecules never get to have the right structure to be functional and they are destroyed. We believe that if we stop the activity of HSP90, the rapidly dividing cells in the tumor(s) will slow down since their proteins will not be functional without the help of HSP90.

Condition Intervention Phase
Ocular Melanoma Drug: STA-9090 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of the HSP Inhibitor STA-9090 in Metastatic Ocular Melanoma

Resource links provided by NLM:


Further study details as provided by F. Stephen Hodi, MD, Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Progression Free Survival Rate [ Time Frame: 2 years ]
    To determine the proportion of patients alive, free of disease progression, and still taking STA-9090 at 4 months.

  • Expression of cMET [ Time Frame: 2 years ]
    To estimate the proportion of patients with greater than 50% decrease in expression of HSP90 client protein c-MET 18-24 hours after administration of STA-9090


Estimated Enrollment: 30
Study Start Date: June 2010
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 200 MG/M2 WEEKLY Drug: STA-9090
Given intravenously once week or twice a week for three weeks of a four week cycle
Experimental: 150 MG/M2 2 X WEEKLY Drug: STA-9090
Given intravenously once week or twice a week for three weeks of a four week cycle

Detailed Description:
  • 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.
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01200238


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Brigham and Women's Hospital
Synta Pharmaceuticals Corp.
Investigators
Principal Investigator: F. Stephen Hodi, MD Dana-Farber Cancer Institute
  More Information

Responsible Party: F. Stephen Hodi, MD, Melanoma Disease Center Director, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01200238     History of Changes
Other Study ID Numbers: 10-137
First Submitted: September 10, 2010
First Posted: September 13, 2010
Last Update Posted: January 6, 2017
Last Verified: January 2017

Keywords provided by F. Stephen Hodi, MD, Dana-Farber Cancer Institute:
STA9090
STA-9090
HSP90

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas