Study of Tumor Samples in Patients Undergoing Radiation Therapy or Surgery For Primary Melanoma of the Eye

Case Comprehensive Cancer Center (Case CCC)

Status: Completed

Conditions: Intraocular Melanoma

Treatments: Other: laboratory biomarker analysis; Procedure: therapeutic conventional surgery; Procedure: fine-needle aspiration; Genetic: fluorescence in situ hybridization; Other: Questionnaires

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00952939

CASE 5608-CC666 (Other Identifier)

P30CA043703 (U.S. NIH Grant/Contract)

CASE5608 (Other Identifier)

Details and patient eligibility

About

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This clinical trial is studying tumor samples in patients undergoing surgery or radiation therapy for primary melanoma of the eye.

Full description

OBJECTIVES:

Primary

• To establish the feasibility of using fine needle aspiration (FNA) and FISH to determine tumor genotype in patients with primary uveal melanoma.

Secondary

• To characterize ophthalmic complication rate of FNA for FISH analysis in patients undergoing plaque radiotherapy.
• To estimate disease-free survival in patients with and without tumor monosomy 3 and/or 8q amplification.
• To explore the relationship between tumor monosomy 3 and 8q amplification and plasma levels of tumor immune escape and invasion biomarkers (e.g., circulating granulysin, beta2-microglobulin, autotoxin, lysophosphatidic acid, matrix metalloproteinase-7, tissue inhibitor of matrix metalloproteinase, and soluble E- cadherin).
• To explore the psychological impact of prognostication in uveal melanoma.

OUTLINE: Patients undergo plaque radiotherapy, enucleation, or tumor resection based upon standard of care guidelines.

Trans-scleral fine needle aspiration (FNA) is performed at the time of plaque radiotherapy and ex vivo FNA is performed on enucleation and tumor resection specimens. Tissue samples are analyzed by fluorescence in situ hybridization (FISH). Blood samples are also collected for further analysis.

After completion of study therapy, patients are followed up periodically.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Patients must have a clinical diagnosis of melanoma of the iris, ciliary body and/or choroids

• Patients must have had a hepatic ultrasound and/or other suitable imaging studies to eliminate metastatic disease

• Patients must not have received any local or systemic therapy for uveal melanoma

• All patients must be informed of the investigational nature of this study and must provide written informed consent in accordance with institutional and federal guidelines. A copy of the informed consent document signed by the patient must be given to the patient

• Patients must have the following pretreatment laboratory findings:

  • Bilirubin (total) </= 1.5 ml/dl
  • AST </= 2 x normal
  • ALT </= 2 x normal
  • Alkaline phosphatase </= 2 x normal

Exclusion Criteria

• Patients with metastasis
• Patients under the age of 18