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
| Status: | Terminated |
|---|---|
| Conditions: | Skin Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | October 2014 |
| End Date: | July 2015 |
Prophylactic Hepatic Irradiation for Uveal Melanoma
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.
(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.
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.
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.
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
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