Conditions: Melanoma
Keywords: Stage III Stage IV Unresectable Metastatic
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 3
Healthy volunteers: no

Brief summary:
STA9090 is a 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 your cells to have the right shape. By stopping HSP90's activity, those molecules never get to have the right structure of be functional and they are destroyed. The investigators believe that if they stop the activity of HSP90, the rapidly dividing cells that are in your tumor(s) may slow down. In this research study the investigators are looking to see how well STA9090 works in stopping the spread of your melanoma.

Detailed description:
OBJECTIVES:

Primary

* To determine the proportion of patients alive, free of disease progression, and still taking STA-9090 at 6 months by BRAF mutant or wild type (WT) status.

Secondary

* To assess best overall response rate and six month response rate by BRAF status
* To evaluate the rates of one-year overall survival and progression-free survival by BRAF status
* To determine safety and tolerability of STA-9090 by BRAF status

Exploratory

* To compare the rates of response and of six-month PFS between BRAF status cohorts
* To explore, using peripheral blood mononuclear cells, the relationship between change in expression of hsp90 client proteins (e.g., BRAF, CRAF, AKT, CDK4, KIT) with response to therapy and progression free survival by BRAF status
* To explore the relationship in biopsied melanoma metastases between changes in expression of hsp90 client proteins (e.g., BRAF, CRAF, AKT, CDK4, KIT) with response to therapy and progression-free survival
* To explore response rate and 6 month progression free survival, in subset of patients with melanoma expressing a mutation in KIT

Arms:
arm 1: Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A - BRAF mutant disease or Cohort B - BRAF wild type. Cohort A patients received STA-9090 200 mg/m2 once weekly (d1, 8, 15 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal. arm 2: Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A - BRAF mutant disease or Cohort B - BRAF wild type. Cohort B patients received STA-9090 150 mg/m2 twice weekly (d1, 4, 8, 11, 15, 18 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.

Interventions: intervention 1: STA-9090
Intervention descriptions: intervention 1: None

Protocol document: