Vaccine Therapy in Treating Patients With Metastatic Melanoma of the Eye

NCT00020475 | Completed Phase 2

• 3 other identifiers: CDR0000068514NCI-01-C-0074NCI-2910
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Combining vaccine therapy with interleukin-2 may be a more effective treatment for metastatic melanoma of the eye. PURPOSE: Phase II trial to study the effectiveness of vaccine therapy and interleukin-2 in treating patients who have metastatic melanoma of the eye.

Conditions

Extraocular Extension Melanoma; Recurrent Intraocular Melanoma

Keywords

adult solid tumor; body system/site cancer; cancer; extraocular extension melanoma; eye cancer; intraocular melanoma; recurrent intraocular melanoma; solid tumor; stage, intraocular melanoma

Interventions

gp100 antigen DRUG

interleukin-2 DRUG

MART-1 antigen DRUG

Montanide ISA-51 DRUG

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Age Groups: Child (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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Surgery Branch

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Uveal Melanoma; Neoplasms; Eye Neoplasms

Interventions

Interleukin-2; MART-1 Antigen; montanide ISA 51

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors; Melanoma-Specific Antigens; Neoplasm Proteins; Antigens, Neoplasm; Antigens

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 1, 2001
• Study Completion: March 1, 2007
• Last Updated: March 4, 2024

Record last verified: 2024-03

Locations

US (1)