Trials Sponsors Conditions Drugs Pricing

Conditions

Extraocular Extension Melanoma Recurrent Intraocular Melanoma

Keywords

adult solid tumorbody system/site cancercancerextraocular extension melanomaeye cancerintraocular melanomarecurrent intraocular melanomasolid tumorstage, intraocular melanoma

Interventions

gp100 antigenDrug

interleukin-2Drug

MART-1 antigenDrug

Eligibility Criteria

Age16 Years+

Sexall

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of metastatic ocular melanoma Progressive disease Measurable disease HLA-A\*201 positive --Prior/Concurrent Therapy-- Biologic therapy: At least 3 weeks since prior biologic therapy Chemotherapy: At least 3 weeks since prior chemotherapy Endocrine therapy: At least 3 weeks since prior endocrine therapy No concurrent steroid therapy Radiotherapy: At least 3 weeks since prior radiotherapy Surgery: Not specified --Patient Characteristics-- Age: 16 and over Performance status: ECOG 0-2 Life expectancy: More than 3 months Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 90,000/mm3 No coagulation disorders Hepatic: Bilirubin no greater than 2.0 mg/dL AST/ALT less than 3 times normal Hepatitis B surface antigen negative Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No major cardiovascular illness For interleukin-2 (IL-2) therapy: No cardiac ischemia No myocardial infarction No cardiac arrhythmias Pulmonary: No major respiratory system illness For IL-2 therapy: No obstructive or restrictive pulmonary disease Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active systemic infection No autoimmune disease No primary or secondary immunodeficiency by abnormal lymphocyte counts or presence of opportunistic infection

Sponsors & Collaborators

National Cancer Institute (NCI)
NIHlead

Study Sites (1)

Surgery Branch

Bethesda, Maryland, 20892, United States

MeSH Terms

Conditions

Uveal MelanomaNeoplasmsEye Neoplasms

Interventions

Interleukin-2MART-1 Antigenmontanide ISA 51

Condition Hierarchy (Ancestors)

MelanomaNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueNevi and MelanomasUveal Neoplasms

Study Officials

Francesco M. Marincola
National Cancer Institute (NCI)
STUDY CHAIR

Study Design

Study Type: interventional
Phase: phase 2
Purpose: TREATMENT
Sponsor Type: NIH

Study Record Dates

First Submitted

March 2, 2007

First Posted

March 6, 2007

Study Start

February 2001

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

March 2007

Actual (reported)

Vaccine Therapy in Treating Patients With Metastatic Melanoma of the Eye

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Study Completion

First Submitted

First Posted

Conditions

Keywords

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Study Completion

First Submitted

First Posted

Conditions

Keywords

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Source record

Locations