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

NCT02336763 | Terminated Results DMC

• 3 other identifiers: 14-000903NCI-2014-02254JCCCID466
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Progression-free Survival

  Up to 5 years

• Reduction in Liver Metastasis

  Up to 5 years

Secondary Outcomes (5)

• 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

• Frequency and Severity of Late Toxicity Per NCI CTCAE Version 4

  More than 3 months after study treatment

• Overall Survival

  Up to 5 years

• Distant Failure Rates

  Up to 5 years

• Disease-specific Survival

  Up to 5 years

Study Arms (1)

Treatment (external beam radiation therapy)

EXPERIMENTAL

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; Other: Laboratory Biomarker Analysis

Interventions

External Beam Radiation Therapy RADIATION

Undergo external beam radiation therapy

Also known as: Definitive Radiation Therapy, EBRT, External Beam RT

Treatment (external beam radiation therapy)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (external beam radiation therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Uveal Melanoma

Condition Hierarchy (Ancestors)

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Uveal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases; Uveal Diseases

Results Point of Contact

• Title: Mitchell Kamrava, MD
• Organization: UCLA

mkamrava@mednet.ucla.edu

310-825-9775

Study Officials

• Mitchell Kamrava

  Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2015
• First Posted: January 13, 2015
• Study Start: October 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: July 24, 2020
• Results First Posted: March 11, 2016

Record last verified: 2016-03

Locations

US (1)