Radiation Therapy in Preventing Liver Metastases in Patients With Uveal Melanoma Who HaveMonosomy 3 or DecisionDx Class 2 Disease and Are More Likely to Develop Liver Metastases

Stopped early · Not applicable

Conditions studied: Iris Melanoma, Medium/Large Size Posterior Uveal Melanoma, Stage IIA Uveal Melanoma, Stage IIB Uveal Melanoma, Stage IIIA Uveal Melanoma, Stage IIIB Uveal Melanoma, Stage IIIC Uveal Melanoma

In brief

This clinical trial studies giving radiation therapy to the liver in patients with uveal (eye) melanoma who have a specific chromosome loss (monosomy 3) or are DecisionDx Class 2 and therefore more likely to have their disease spread from the eye to the liver. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Early radiation to the liver may reduce the development of tumors in the liver and the overall risk of disease recurrence.

Key facts

Study ID

NCT02336763

Run by

Jonsson Comprehensive Cancer Center

People needed

2

Starts

2014-10-01

Expected to finish

2015-07-01

Last updated by the study team

2020-07-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed uveal melanoma
• Monosomy 3 status (by fluorescent in situ hybridization [FISH] or multiplex ligation-dependent probe amplification [MLPA]) or DecisionDx class 2
• Tumor thickness > 3.0 mm
• Has received definitive treatment of uveal melanoma with brachytherapy, proton therapy, stereotactic radiosurgery, or enucleation
• Karnofsky performance status (KPS) >= 70 or Eastern Cooperative Oncology Group (ECOG)
• Total bilirubin < 1.5 mg/dl
• Aspartate transaminase (AST) up to two times normal limit
• Alanine transaminase (ALT) up to two times normal limit
• Creatinine < 2.0 mg/dl
• Functional left kidney based on computed tomography (CT) imaging
• Positron emission tomography (PET)/CT demonstrating no evidence of metastatic disease
• If a woman is of childbearing potential, a negative serum pregnancy test must be documented; women of childbearing potential must agree to use contraception for the duration of radiation therapy (approximately 3 weeks)
• Understands the trial and procedures and is willing and able to sign the Informed Consent Form

You may not qualify if…

• Previous malignancy, other than localized cutaneous squamous cell carcinoma or basal cell carcinoma
• History of prior irradiation to the thorax or abdomen
• Inadequate hepatic or kidney function (as specified above)
• Active peptic ulcer disease
• Upper gastrointestinal bleeding
• Pregnant women or women that refuse to use contraception throughout the entire study period
• Currently receiving chemotherapy
• Refuses to sign the informed consent form

Where it is running

• Jonsson Comprehensive Cancer Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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