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Panobinostat (LBH589) in Patients With Metastatic Melanoma

2014-08-27 03:16:02 | BioPortfolio

Summary

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.

Description

- Each treatment cycle lasts 28 days. During the cycles, participants will be taking LBH589 three days a week: on Monday, Wednesday and Friday.

- 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 women of child-bearing potential, they 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 9 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Melanoma

Intervention

LBH589

Location

Dana-Farber Cancer Institute
Boston
Massachusetts
United States
02115

Status

Not yet recruiting

Source

Dana-Farber Cancer Institute

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:02-0400

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Medical and Biotech [MESH] Definitions

An unpigmented malignant melanoma. It is an anaplastic melanoma consisting of cells derived from melanoblasts but not forming melanin. (Dorland, 27th ed; Stedman, 25th ed)

Experimentally induced tumor that produces MELANIN in animals to provide a model for studying human MELANOMA.

A cellular subtype of malignant melanoma. It is a pigmented lesion composed of melanocytes occurring on sun-exposed skin, usually the face and neck. The melanocytes are commonly multinucleated with a "starburst" appearance. It is considered by many to be the in situ phase of lentigo maligna melanoma.

Found in large amounts in the plasma and urine of patients with malignant melanoma. It is therefore used in the diagnosis of melanoma and for the detection of postoperative metastases. Cysteinyldopa is believed to be formed by the rapid enzymatic hydrolysis of 5-S-glutathionedopa found in melanin-producing cells.

A melanosome-specific protein that plays a role in the expression, stability, trafficking, and processing of GP100 MELANOMA ANTIGEN, which is critical to the formation of Stage II MELANOSOMES. The protein is used as an antigen marker for MELANOMA cells.

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