Imatinib in Patients With Mucosal or Acral/Lentiginous Melanoma (BUS255)
|ClinicalTrials.gov Identifier: NCT00424515|
Recruitment Status : Completed
First Posted : January 19, 2007
Results First Posted : December 8, 2016
Last Update Posted : December 8, 2016
|Condition or disease||Intervention/treatment||Phase|
|Mucosal Melanoma Acral/Lentiginous Melanoma Chronically Sun Damaged Melanomas||Drug: Imatinib||Phase 2|
- To determine the response rate of patients with metastatic mucosal, acral/lentiginous, or chronically sun damaged melanomas to treatment with of imatinib.
- To determine the time to progression.
- To correlate c-kit mutational status with response to therapy.
- To evaluate the use of FDG-PET scanning in determining early biologic response to therapy.
- Tolerability of imatinib.
- To assess amplification of c-kit status through quantitative PCR and/or FISH and other related molecular pathway targets.
- To correlate c-kit amplification status with response to therapy.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Imatinib in Patients With Mucosal or Acral/Lentiginous Melanoma and Melanomas That Arise on Chronically Sun Damaged Skin.|
|Study Start Date :||July 2006|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||July 2011|
Experimental: Treatment Arm
Imatinib was given at a dose of 400 mg orally daily (4 100mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition.
Other Name: Gleevec
- Best Overall Response [ Time Frame: Disease was evaluated radiologically at baseline, after 6-weeks, and at 2-month intervals on treatment. Mean treatment duration was 4 months (range 1-11; amplified/mutated 3m/ 6m). ]Best overall response (BOR) on treatment was based on RECIST 1.0 criteria. For target lesions, complete response (CR) is complete disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. CR or PR confirmation required within 4 weeks. Progressive disease (PD) is at least a 20% increase in the sum LD of target lesions from smallest sum LD as reference or the appearance of one or more new lesions. Stable disease (SD) is neither meeting PR or PD. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. CR is disappearance of all non-target lesions.
- Time to Progression [ Time Frame: Disease was evaluated radiologically at baseline, after 6-weeks, and at 2-month intervals on treatment and every 3 months long-term. Mean treatment duration was 4 months (range 1-11; amplified/mutated 3m/ 6m). ]Time to progression (TTP) based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.
- Overall Survival [ Time Frame: Patients were followed long-term every 3 months until first progression, death or lost to follow-up. Median survival follow-up was 10.6 months (range 3.7-27.1). ]Overall survival (OS) is defined as the time from study entry to death or date last known alive.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00424515
|United States, Colorado|
|University of Colorado at Denver Health Sciences Center|
|Denver, Colorado, United States, 80045|
|United States, Florida|
|H. Lee Moffitt Cancer Center|
|Tampa, Florida, United States, 33612|
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|United States, Texas|
|MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||F. Stephen Hodi, MD||Dana-Farber Cancer Institute|