Vaccine Therapy in Treating Patients With Metastatic Melanoma of the Eye

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00020475
Recruitment Status : Completed
First Posted : March 6, 2007
Last Update Posted : August 16, 2013
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Extraocular Extension Melanoma Recurrent Intraocular Melanoma Drug: gp100 antigen Drug: interleukin-2 Drug: MART-1 antigen Drug: Montanide ISA-51 Phase 2

Detailed Description:

OBJECTIVES: I. Determine the clinical response in patients with metastatic ocular melanoma treated with gp100:209-217 (210M) antigen and MART-1:26-35 (27L) antigen emulsified in Montanide ISA-51.

II. Determine the clinical benefit of interleukin-2 in combination with this vaccine in these patients.

PROTOCOL OUTLINE: Patients receive vaccine subcutaneously once weekly. Treatment repeats every 4 weeks for a total of 6 courses in the absence of disease progression or unacceptable toxicity.

Patients with progressive disease may receive vaccine SC on day 1 followed by interleukin-2 IV over 15 minutes every 8 hours for a maximum of 12 doses. Treatment repeats every 3 weeks for at least 4 courses in the absence of disease progression or unacceptable toxicity.


A total of 15-25 patients will be accrued for this study within 1 year.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Phase II Study of gp100:209-217 (210M) Antigen and MART-1:26-35 (27L) Antigen Emulsified in Montanide ISA-51 in Patients With Metastatic Ocular Melanoma
Study Start Date : February 2001
Study Completion Date : March 2007

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)


--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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00020475

United States, Maryland
Surgery Branch
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
Study Chair: Francesco M. Marincola National Cancer Institute (NCI) Identifier: NCT00020475     History of Changes
Obsolete Identifiers: NCT00009516
Other Study ID Numbers: CDR0000068514
First Posted: March 6, 2007    Key Record Dates
Last Update Posted: August 16, 2013
Last Verified: July 2002

Keywords provided by National Cancer Institute (NCI):
adult solid tumor
body system/site cancer
extraocular extension melanoma
eye cancer
intraocular melanoma
recurrent intraocular melanoma
solid tumor
stage, intraocular melanoma

Additional relevant MeSH terms:
Uveal Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Eye Neoplasms
Neoplasms by Site
Eye Diseases
Uveal Diseases
Freund's Adjuvant
Antineoplastic Agents
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adjuvants, Immunologic
Immunologic Factors