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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


Phase 2
16 Years
N/A
Not Enrolling
Both
Extraocular Extension Melanoma, Recurrent Intraocular Melanoma

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Francesco M. Marincola

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

CDR0000068514

NCT ID:

NCT00020475

Start Date:

February 2001

Completion Date:

Related Keywords:

  • Extraocular Extension Melanoma
  • Recurrent Intraocular Melanoma
  • adult solid tumor
  • body system/site cancer
  • cancer
  • extraocular extension melanoma
  • eye cancer
  • intraocular melanoma
  • recurrent intraocular melanoma
  • solid tumor
  • stage, intraocular melanoma
  • Melanoma
  • Uveal Neoplasms

Name

Location

Surgery BranchBethesda, Maryland  20892