Panobinostat (LBH589) in Patients With Metastatic Melanoma
The purpose of this research study is to determine the safety of LBH589 as well as to find out what side effects it may cause and how effective it is against melanoma. LBH589 is a drug which may slow down the growth of cancer cells or kill cancer cells by blocking certain enzymes, which are proteins normally produced by cells. These enzymes are known to play an important role in the development and reproduction of cancer cells. It is believed that LBH589 works by helping to promote the activity of enzymes which turn on the mechanisms in our cells that suppress cells from becoming cancerous.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot/Phase I Study of Panobinostat (LBH589) in Patients With Metastatic Melanoma|
- To obtain an early evaluation of efficacy by response rate using RECIST criteria. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Tp determine whether LBH589 effectively down regulates MITF in biopsy specimens of treated metastatic melanoma patients [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- To estimate the disease control rate using RECIST criteria [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- To estimate time to disease progression. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||February 2010|
|Estimated Study Completion Date:||February 2015|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
Taken orally three times per week.
Other Name: Panobinostat
- Each treatment cycle lasts 28 days. During the cycles, participants will be taking LBH589 three days a week(Monday, Wednesday and Friday) every other week.
- During all treatment cycles participants will have a physical exam and will be asked general questions about their health and specific questions about any problems that they may be having. Participants will be seen at least weekly during the first cycle and then at least monthly while they remain on the study.
- Blood tests will be taken to check blood cell counts, how well their organs are functioning and to test for any infections. These blood samples will be obtained prior to the start of every cycle and at least weekly during the first cycle on this study.
- If the participant is a woman of child-bearing potential, she will be asked to undergo either a blood test or provide a urine specimen to check for pregnancy before starting cycle 1 and prior to the start of all subsequent cycles.
- As it is possible for LBH589 to affect the rhythm of the heart, EKGs will be checked frequently during participation on this study. These EKGs will be performed at the following time points: Cycle 1, day 1; Cycle 1, day 5; Cycle 1, Day 8; Cycle 1 day 15; and day 1 of each subsequent cycles.
- CT scans of the chest, abdomen and pelvis and an MRI of the brain will be performed after every 2 cycles or every 56 days.
- A second sample of the participant's tumor will be removed at the end of the first cycle on study.
- Participants will be in this research study for at least 2 months and may continue on the study of they are benefitting from the drug and are not experiencing any serious side effects.
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||F. Stephen Hodi, MD||Dana-Farber Cancer Institute|