Intraocular Melanoma Clinical Trial
Official title:
Prognostication of Uveal Melanoma by Fine Needle Aspiration (FNA) and Fluorescence in Situ Hybridization (FlSH)
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.
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.
;
Observational Model: Case-Only, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT01217398 -
Temozolomide and Bevacizumab in Treating Patients With Metastatic Melanoma of the Eye
|
Phase 2 | |
| Completed |
NCT00471471 -
Vaccine Therapy in Treating Patients With Recurrent Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery
|
Phase 1 | |
| Completed |
NCT00398073 -
Vaccine Therapy in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Melanoma
|
N/A | |
| Completed |
NCT00334776 -
Vaccine Therapy in Treating Patients With Metastatic Melanoma
|
Phase 2 | |
| Completed |
NCT00025181 -
Monoclonal Antibody and Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Has Been Removed During Surgery
|
Phase 1 | |
| Terminated |
NCT00002947 -
Indium In 111 Pentetreotide in Treating Patients With Refractory Cancer
|
Phase 1 | |
| Completed |
NCT00897624 -
Bone Marrow and Blood Samples From Patients With Metastatic Choroid Melanoma
|
N/A | |
| Completed |
NCT00003339 -
Vaccine Therapy With or Without Interleukin-12 in Treating Patients With Stage III or Stage IV Melanoma
|
Phase 2 | |
| Completed |
NCT00084656 -
Monoclonal Antibody Therapy and Vaccine Therapy in Treating Patients With Resected Stage III or Stage IV Melanoma
|
Phase 2 | |
| Completed |
NCT00705640 -
Vaccine Therapy in Treating Patients With Advanced Melanoma
|
Phase 1 | |
| Recruiting |
NCT00489944 -
Sunitinib, Tamoxifen, and Cisplatin in Treating Patients With High-Risk Ocular Melanoma
|
Phase 2 | |
| Completed |
NCT00027742 -
Temozolomide and Interferon Alfa in Treating Patients With Stage III or Stage IV Melanoma
|
Phase 2 | |
| Terminated |
NCT00005841 -
Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma
|
Phase 1 | |
| Completed |
NCT00072345 -
Temozolomide, Thalidomide, and Lomustine in Treating Patients With Unresectable Stage III or Stage IV Melanoma
|
Phase 2 | |
| Completed |
NCT00089219 -
Vaccine Therapy in Treating Patients With Stage IIIB, Stage IIIC, or Stage IV Melanoma
|
Phase 1/Phase 2 | |
| Completed |
NCT00445965 -
Iodine I 131 Monoclonal Antibody 3F8 in Treating Patients With Central Nervous System Cancer or Leptomeningeal Cancer
|
Phase 2 | |
| Completed |
NCT00243061 -
AZD2171 in Treating Patients With Recurrent or Stage IV Melanoma
|
Phase 2 | |
| Terminated |
NCT00110123 -
Intravenous or Hepatic Arterial Infusion of Fotemustine in Treating Patients With Unresectable Liver Metastases From Eye Melanoma
|
Phase 3 | |
| Completed |
NCT00032045 -
Vaccine Therapy and Monoclonal Antibody Therapy in Treating Patients With Stage IV Melanoma
|
Phase 2 | |
| Completed |
NCT00238329 -
PEG-Interferon Alfa-2b and Thalidomide in Treating Patients With Recurrent or Metastatic Melanoma
|
Phase 2 |