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

Iris Melanoma Clinical Trial

Official title:

Prophylactic Hepatic Irradiation for Uveal Melanoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02336763
• Other study ID #: 14-000903
• Secondary ID: NCI-2014-02254JC
• Status: Terminated
• Phase: N/A
• Start date: October 2014
• Est. completion date: July 2015

Study information

• Verified date: March 2016
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Iris Melanoma
• Medium/Large Size Posterior Uveal Melanoma
• Melanoma
• Stage IIA Uveal Melanoma
• Stage IIB Uveal Melanoma
• Stage IIIA Uveal Melanoma
• Stage IIIB Uveal Melanoma
• Stage IIIC Uveal Melanoma
• Uveal Neoplasms

Intervention

Radiation:
• External Beam Radiation Therapy
Undergo external beam radiation therapy

Other:
• Laboratory Biomarker Analysis
Correlative studies

Locations

Country	Name	City	State
United States	Jonsson Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival		Up to 5 years
Primary	Reduction in Liver Metastasis		Up to 5 years
Secondary	Frequency and Severity of Acute Toxicity Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4		Within 3 months of study treatment
Secondary	Frequency and Severity of Late Toxicity Per NCI CTCAE Version 4		More than 3 months after study treatment
Secondary	Overall Survival		Up to 5 years
Secondary	Distant Failure Rates	Cumulative incidence approach (Kaplan-Meier [K-M] plots and Cox proportional hazard modeling) will be used to estimate distant failure rates.	Up to 5 years
Secondary	Disease-specific Survival	Cumulative incidence approach (K-M plots and Cox proportional hazard modeling) will be used to estimate disease-specific survival.	Up to 5 years