An Open-label, Multicenter, Single-arm, Phase I Dose-escalation with Efficacy Tail Extension study of R05185426 in Pediatric Patients with Surgically Incurable and Unresectable Stage IIIC or Stage IV Melanoma Harboring BRAFV600

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Research

Protocol

MELPLX: An Open-label, Multicenter, Single-arm, Phase I Dose-escalation with Efficacy Tail Extension study of R05185426 in Pediatric Patients with Surgically Incurable and Unresectable Stage IIIC or Stage IV Melanoma Harboring BRAFV600

Diseases

Solid Tumor : melanoma

Description

This study is for patients ages 12 to 17 years suffering from malignant melanoma and cannot be cured with surgery, or has been previously treated and is no longer responding to treatment.

RO5185426 is an investigational drug being studied by Roche. “Investigational” means that this drug has not been approved by the Food and Drug Administration for use in children with your disease at this time. RO5185426 has recently been approved for treatment of adults with malignant melanoma.

Researchers have found that a large number of melanomas, as well as other tumors, have mutations (changes) in a gene called the BRAF gene. Genes are a specific part of your DNA that contain information on hereditary characteristics such as hair color and eye color.

The BRAF gene makes a protein called BRAF, which is involved in sending signals within cells for cell growth. Certain mutations in the BRAF gene cause a change in the BRAF protein that can increase the growth and spread of cancer cells. RO5185426 works by preventing these altered BRAF proteins from working, which may result in blocking the growth and spread of the cancer cells. Only people with this mutation in the BRAF gene are eligible to take part in this study and receive this drug.

Objectives

To find the correct dose of RO5185426 that should be used in children, aged 12-17 years with melanoma.
To see how long the drug stays in the body and how well the body can remove the drug (also called pharmacokinetics).
To find out what the effects are (good and bad) of the drug in children aged 12-17 years with melanoma.

Eligibility

Patients may have newly diagnosed or recurrent melanoma
Patients with histologically confirmed surgically incurable and unresectable
Stage IIIC or Stage IV (AJCC) melanomaPatients aged ≥ 12 to ≤ 17 years
Able to swallow pills
Patients of childbearing or child-fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated in this study and for at least 6 months after completion of treatment
Patients with active or untreated CNS lesions or history of or known spinal cord compression or carcinomatous meningitis or history of allogeneic bone marrow transplantation or organ transplantation are not eligible for the study

For the current eligibility status of this clinical study, referring physicians must contact St. Jude Children's Research Hospital at 1-866-2ST-JUDE (1-866-278-5833).

Contact

Fariba Navid, MD
St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105 USA
Voice: 1-888-226-4343 or 901-595-4055
Fax: 901-595-4011

Referring or consulting physicians only: protocolinfo@stjude.org

For all other inquiries about St. Jude Children's Research Hospital studies: info@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.

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