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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

Primary Purpose

Iris Melanoma, Medium/Large Size Posterior Uveal Melanoma, Stage IIA Uveal Melanoma

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
External Beam Radiation Therapy
Laboratory Biomarker Analysis
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Iris Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Jonsson Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (external beam radiation therapy)

Arm Description

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

Outcomes

Primary Outcome Measures

Progression-free Survival
Reduction in Liver Metastasis

Secondary Outcome Measures

Frequency and Severity of Acute Toxicity Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4
Frequency and Severity of Late Toxicity Per NCI CTCAE Version 4
Overall Survival
Distant Failure Rates
Cumulative incidence approach (Kaplan-Meier [K-M] plots and Cox proportional hazard modeling) will be used to estimate distant failure rates.
Disease-specific Survival
Cumulative incidence approach (K-M plots and Cox proportional hazard modeling) will be used to estimate disease-specific survival.

Full Information

First Posted
January 8, 2015
Last Updated
July 22, 2020
Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02336763
Brief Title
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

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Terminated
Why Stopped
Closed due to lack of accrual
Study Start Date
October 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (external beam radiation therapy)
Arm Type
Experimental
Arm Description
Patients undergo external beam radiation therapy daily over 20 minutes on Monday-Friday for up to 10 fractions over approximately 2 weeks.
Intervention Type
Radiation
Intervention Name(s)
External Beam Radiation Therapy
Other Intervention Name(s)
Definitive Radiation Therapy, EBRT, External Beam RT
Intervention Description
Undergo external beam radiation therapy
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Progression-free Survival
Time Frame
Up to 5 years
Title
Reduction in Liver Metastasis
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Frequency and Severity of Acute Toxicity Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4
Time Frame
Within 3 months of study treatment
Title
Frequency and Severity of Late Toxicity Per NCI CTCAE Version 4
Time Frame
More than 3 months after study treatment
Title
Overall Survival
Time Frame
Up to 5 years
Title
Distant Failure Rates
Description
Cumulative incidence approach (Kaplan-Meier [K-M] plots and Cox proportional hazard modeling) will be used to estimate distant failure rates.
Time Frame
Up to 5 years
Title
Disease-specific Survival
Description
Cumulative incidence approach (K-M plots and Cox proportional hazard modeling) will be used to estimate disease-specific survival.
Time Frame
Up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitchell Kamrava
Organizational Affiliation
Jonsson Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jonsson Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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