Vaccine Therapy in Treating Patients With Metastatic Melanoma of the Eye

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00020475
First received: March 2, 2007
Last updated: August 14, 2013
Last verified: July 2002
  Purpose

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 Intervention Phase
Extraocular Extension Melanoma
Recurrent Intraocular Melanoma
Drug: gp100 antigen
Drug: interleukin-2
Drug: MART-1 antigen
Drug: Montanide ISA-51
Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: February 2001
Study Completion Date: March 2007
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.

  Eligibility

Ages Eligible for Study:   16 Years and older
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00020475

Locations
United States, Maryland
Surgery Branch
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Study Chair: Francesco M. Marincola National Cancer Institute (NCI)
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00020475     History of Changes
Obsolete Identifiers: NCT00009516
Other Study ID Numbers: CDR0000068514, NCI-01-C-0074, NCI-2910
Study First Received: March 2, 2007
Last Updated: August 14, 2013
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Melanoma
Uveal Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Eye Neoplasms
Neoplasms by Site
Eye Diseases
Uveal Diseases
Interleukin-2
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014