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CompletedNCT00031733Updated May 22, 2014

Vaccine Therapy and Interleukin-12 With Either Alum or Sargramostim After Surgery in Treating Patients With Melanoma

A Phase 2 interventional study of MART-1 antigen and gp100 antigen in Intraocular Melanoma and Melanoma (Skin), sponsored by University of Southern California. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-05-22.

Sponsored by University of Southern California · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

RATIONALE: Vaccines made from peptides may make the body build an immune response. Combining vaccine therapy with interleukin-12 and either alum or sargramostim may kill more tumor cells.

PURPOSE: Randomized phase II trial to compare the effectiveness of combining vaccine therapy with interleukin-12 and either alum or sargramostim in treating patients who have undergone surgery for stage II, stage III, or stage IV melanoma.

Read the detailed description

OBJECTIVES:

  • Compare the immune reactivity in patients with resected stage IIB, IIC, III, or IV melanoma vaccinated with tyrosinase, gp100, and MART-1 peptides emulsified with Montanide ISA-51 with interleukin-12 and either alum adjuvant or sargramostim (GM-CSF).

OUTLINE: This is a randomized study. Patients are stratified according to disease stage (cutaneous stage IIB, IIC, III, and IV vs ocular and mucosal stage III and IV). Patients are randomized to 1 of 3 treatment arms.

  • Arm I: Patients receive vaccine with tyrosinase:368-376 (370D)/gp100:209-217 (210M)/MART-1:26-27 (27L) peptides emulsified with Montanide ISA-51 (ISA-51), low-dose interleukin-12 (IL-12) subcutaneously (SC), and alum adjuvant SC on day 1 of weeks 1, 3, 5, 7, 11, 15, 19, 27, and 53.
  • Arm II: Patients receive peptide vaccine emulsified with ISA-51, high-dose IL-12 SC, and alum adjuvant SC on day 1 of weeks 1, 3, 5, 7, 11, 15, 19, 27, and 53.
  • Arm III: Patients receive peptide vaccine emulsified with ISA-51 on day 1 and low-dose IL-12 SC and sargramostim (GM-CSF) SC on days 1-5 of weeks 1, 3, 5, 7, 11, 15, 19, 27, and 53.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 60 patients (20 per treatment arm) will be accrued for this study within 3 years.

02

Conditions studied

  • Intraocular Melanoma
  • Melanoma (Skin)

Keywords

  • iris melanoma
  • ciliary body and choroid melanoma, small size
  • ciliary body and choroid melanoma, medium/large size
  • extraocular extension melanoma
  • recurrent intraocular melanoma
  • stage II melanoma
  • stage III melanoma
  • stage IV melanoma
  • recurrent melanoma
03

In context

Uveal Melanoma

109 studies on the registry are indexed under Uveal Melanoma; 37 are open to participants now.

This study's enrollment of 60 is above the median of 40 across 98 interventional studies indexed under Uveal Melanoma.

Browse Uveal Melanoma studies →

Lead sponsor

University of Southern California is the lead sponsor of 789 studies on the registry; 136 are open to participants now.

Of its 69 completed or terminated interventional studies of FDA-regulated products, 32 (46%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of stage IIB, IIC, III, or IV cutaneous melanoma OR stage III or IV ocular or mucosal melanoma

    • Resected or rendered disease-free
  • HLA-A2.1-positive by standard cytotoxicity assay
  • Tumor tissue must be available for analysis of gp100 staining and tyrosinase and MART-1 expression by immunohistochemistry

    • Must be positive for at least 1 antigen
  • Failed, ineligible for, or refused prior interferon alfa

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC at least 3,000/mm\^3
  • Granulocyte count at least 1,500/mm\^3
  • Platelet count at least 100,000/mm\^3
  • Hemoglobin at least 9.0 g/dL
  • No bleeding disorder

Hepatic:

  • Bilirubin no greater than 2.0 mg/dL
  • SGOT/SGPT no greater than 2.5 times normal
  • No coagulation disorder
  • Hepatitis surface antigen B negative
  • Hepatitis C negative

Renal:

  • Creatinine no greater than 2.0 mg/dL

Cardiovascular:

  • No major cardiovascular illness

Pulmonary:

  • No major respiratory illness

Immunologic:

  • No prior uveitis
  • No prior autoimmune inflammatory eye disease
  • No immune hemolytic anemia
  • No other active autoimmune disease

Other:

  • HIV negative
  • No major gastrointestinal illness
  • No other malignancy within the past 5 years except squamous cell skin cancer or carcinoma in situ of the cervix curatively treated at least 30 days ago
  • No major systemic infection (e.g., pneumonia or sepsis)
  • No other major medical illness
  • No prior allergic reaction to Montanide ISA-51 or alum adjuvant
  • No requirement for steroid therapy
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics
  • No prior tyrosinase:368-376 (370D), gp100:209-217 (210M), or MART-1:26-35 (27L) peptides

Chemotherapy:

  • At least 1 month since prior adjuvant chemotherapy for this disease
  • No concurrent adjuvant chemotherapy

Endocrine therapy:

  • No concurrent steroids

Radiotherapy:

  • At least 1 month since prior radiotherapy for this disease
  • No concurrent radiotherapy

Surgery:

  • See Disease Characteristics

Other:

  • At least 1 month since other prior therapy, including adjuvant therapy, for this disease
  • No other concurrent therapy, including adjuvant therapy
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Enrollment
60 participants (actual)

Interventions

06

Study locations

1 site
  • USC/Norris Comprehensive Cancer Center and Hospital
    Los Angeles, California 90089, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00031733
Responsible party
Sponsor
First posted
Jan 27, 2003
Start date
Feb 2002
Primary completion
Dec 2004
Completion
Nov 2007
Last update
May 22, 2014

Study contacts

Jeffrey S. Weber, MD, PhD
study chair · University of Southern California

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: MART-1 Antigen · GP-100 antigen · Interleukin-12 · Sargramostim

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