Clinical trial NCT02336763: 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
Official title: Prophylactic Hepatic Irradiation for Uveal Melanoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
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
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-01-13
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Progression-free Survival
timeFrame: Up to 5 years
measure: Reduction in Liver Metastasis
timeFrame: Up to 5 years
Secondary outcomes:
measure: Frequency and Severity of Acute Toxicity Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4
timeFrame: Within 3 months of study treatment
measure: Frequency and Severity of Late Toxicity Per NCI CTCAE Version 4
timeFrame: More than 3 months after study treatment
measure: Overall Survival
timeFrame: Up to 5 years
measure: Distant Failure Rates
timeFrame: Up to 5 years
measure: Disease-specific Survival
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Jonsson Comprehensive Cancer Center
state: California
Study officials:
affiliation: Jonsson Comprehensive Cancer Center
name: Mitchell Kamrava
role: PRINCIPAL_INVESTIGATOR
References: