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

Jonsson Comprehensive Cancer Center

Status: Terminated

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

Treatments: Radiation: External Beam Radiation Therapy; Other: Laboratory Biomarker Analysis

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02336763

JCCCID466 (Other Identifier)

14-000903

NCI-2014-02254 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

PRIMARY OBJECTIVES:

I. Progression free survival in patients treated with prophylactic hepatic irradiation.

SECONDARY OBJECTIVES:

I. Acute and late term toxicity and overall survival.

OUTLINE:

Patients undergo external beam radiation therapy daily over 20 minutes on Monday-Friday for 10 fractions over approximately 2 weeks.

After completion of study treatment, patients are followed up every 6 months for 5 years.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

Treatment (external beam radiation therapy)

Experimental group

Description:

Patients undergo external beam radiation therapy daily over 20 minutes on Monday-Friday for up to 10 fractions over approximately 2 weeks.

Treatment:

Other: Laboratory Biomarker Analysis

Radiation: External Beam Radiation Therapy