Saracatinib in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed By Surgery
This phase II trial is studying how well saracatinib works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery. Saracatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
Stage IIA Melanoma
Stage IIB Melanoma
Stage IIC Melanoma
Stage IV Melanoma
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2 Study of AZD0530 in Metastatic Melanoma|
- Response rate [ Time Frame: At baseline and every 4-8 weeks for up to 8 weeks ] [ Designated as safety issue: No ]Response will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST). A sum of the longest diameter (LD) for all target lesions will be calculated and reported as the baseline sum LD. The baseline sum LD will be used as reference by which to characterize the objective tumor response. All of the patients who met the eligibility criteria (with the possible exception of those who received no study medication) should be included in the main analysis of the response rate.
- Median progression-free survival [ Time Frame: From day one of treatment to the time of disease progression, assessed up to 8 weeks ] [ Designated as safety issue: No ]Progression will be evaluated in this study using the new international criteria proposed by the RECIST Committee.
- T cell activation [ Time Frame: At baseline and after 3-4 weeks of study therapy ] [ Designated as safety issue: No ]A paired t-test will be used to assess differences between the two time points. Changes in staphylococcal enterotoxin type A (ASEA)-induced interferon gamma production will be assessed in post- versus pre-treatment peripheral blood lymphocyte (PBL) samples.
|Study Start Date:||July 2006|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
Experimental: Treatment (enzyme inhibitor therapy)
Patients receive saracatinib PO QD in the absence of disease progression or unacceptable toxicity.
Other Name: AZD0530Other: laboratory biomarker analysis
I. To determine whether the Src kinase inhibitor, AZD0530 (saracatinib), has single agent clinical activity in patients with advanced melanoma.
II. To determine whether this drug will increase progression-free survival of these patients from 3 months to 4.5 months.
I. To determine whether this drug may inhibit the activation of peripheral blood T cells analyzed ex vivo.
Patients receive saracatinib orally (PO) once daily (QD) in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed for up to 8 weeks.
|United States, Illinois|
|University of Chicago Comprehensive Cancer Center|
|Chicago, Illinois, United States, 60637-1470|
|Principal Investigator:||Thomas Gajewski||University of Chicago Comprehensive Cancer Center|