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Vaccine Therapy in Treating Patients With Metastatic Melanoma of the Eye

Primary Purpose

Extraocular Extension Melanoma, Recurrent Intraocular Melanoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
gp100 antigen
interleukin-2
MART-1 antigen
Montanide ISA-51
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Extraocular Extension Melanoma focused on measuring adult solid tumor, body system/site cancer, cancer, extraocular extension melanoma, eye cancer, intraocular melanoma, recurrent intraocular melanoma, solid tumor, stage, intraocular melanoma

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)

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

Sites / Locations

  • Surgery Branch

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 2, 2007
Last Updated
August 14, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00020475
Brief Title
Vaccine Therapy in Treating Patients With Metastatic Melanoma of the Eye
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 Type
Interventional

2. Study Status

Record Verification Date
July 2002
Overall Recruitment Status
Completed
Study Start Date
February 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
gp100 antigen
Intervention Type
Drug
Intervention Name(s)
interleukin-2
Intervention Type
Drug
Intervention Name(s)
MART-1 antigen
Intervention Type
Drug
Intervention Name(s)
Montanide ISA-51

10. Eligibility

Minimum Age & Unit of Time
16 Years
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesco M. Marincola
Organizational Affiliation
National Cancer Institute (NCI)
Official's Role
Study Chair
Facility Information:
Facility Name
Surgery Branch
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Vaccine Therapy in Treating Patients With Metastatic Melanoma of the Eye

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