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

NCT ID: NCT02336763

Last Updated: 2020-07-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-07-31

Brief Summary

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.

Detailed 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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Treatment (external beam radiation therapy)

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

Group Type: EXPERIMENTAL

External Beam Radiation Therapy

Intervention Type: RADIATION

Undergo external beam radiation therapy

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

Interventions

External Beam Radiation Therapy

Undergo external beam radiation therapy

Intervention Type: RADIATION

Laboratory Biomarker Analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

Definitive Radiation Therapy; EBRT; External Beam RT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mitchell Kamrava

Role: PRINCIPAL_INVESTIGATOR

Jonsson Comprehensive Cancer Center

Locations

Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

NCI-2014-02254

Identifier Type: REGISTRY

Identifier Source: secondary_id

JCCCID466

Identifier Type: OTHER

Identifier Source: secondary_id

14-000903

Identifier Type: -

Identifier Source: org_study_id