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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

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ClinicalTrials.gov Identifier: NCT02336763
Recruitment Status : Terminated (Closed due to lack of accrual)
First Posted : January 13, 2015
Results First Posted : March 11, 2016
Last Update Posted : April 11, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment Phase
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 Radiation: External Beam Radiation Therapy Other: Laboratory Biomarker Analysis Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prophylactic Hepatic Irradiation for Uveal Melanoma
Study Start Date : October 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015


Arm Intervention/treatment
Experimental: 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.
Radiation: External Beam Radiation Therapy
Undergo external beam radiation therapy
Other Names:
  • Definitive Radiation Therapy
  • EBRT
  • External Beam RT

Other: Laboratory Biomarker Analysis
Correlative studies




Primary Outcome Measures :
  1. Progression-free Survival [ Time Frame: Up to 5 years ]
  2. Reduction in Liver Metastasis [ Time Frame: Up to 5 years ]

Secondary Outcome Measures :
  1. 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 ]
  2. Frequency and Severity of Late Toxicity Per NCI CTCAE Version 4 [ Time Frame: More than 3 months after study treatment ]
  3. Overall Survival [ Time Frame: Up to 5 years ]
  4. Distant Failure Rates [ Time Frame: Up to 5 years ]
    Cumulative incidence approach (Kaplan-Meier [K-M] plots and Cox proportional hazard modeling) will be used to estimate distant failure rates.

  5. Disease-specific Survival [ Time Frame: Up to 5 years ]
    Cumulative incidence approach (K-M plots and Cox proportional hazard modeling) will be used to estimate disease-specific survival.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02336763


Locations
United States, California
Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Mitchell Kamrava Jonsson Comprehensive Cancer Center

Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02336763     History of Changes
Other Study ID Numbers: 14-000903
NCI-2014-02254 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
JCCCID466
14-000903 ( Other Identifier: Jonsson Comprehensive Cancer Center )
P30CA016042 ( U.S. NIH Grant/Contract )
First Posted: January 13, 2015    Key Record Dates
Results First Posted: March 11, 2016
Last Update Posted: April 11, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Melanoma
Uveal Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Eye Neoplasms
Neoplasms by Site
Eye Diseases
Uveal Diseases