NCT00085189

Brief Summary

This pilot phase II trial studies how well giving vaccine therapy works in treating patients with stage IIC-IV melanoma. Vaccines made from melanoma peptides or antigens may help the body build an effective immune response to kill tumor cells

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2004

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 10, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 11, 2004

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

May 22, 2014

Status Verified

May 1, 2014

Enrollment Period

3.3 years

First QC Date

June 10, 2004

Last Update Submit

May 20, 2014

Conditions

Ciliary Body and Choroid Melanoma, Medium/Large SizeCiliary Body and Choroid Melanoma, Small SizeExtraocular Extension MelanomaIris MelanomaMetastatic Intraocular MelanomaMucosal MelanomaRecurrent Intraocular MelanomaRecurrent MelanomaStage IIC MelanomaStage IIIA Intraocular MelanomaStage IIIA MelanomaStage IIIB Intraocular MelanomaStage IIIB MelanomaStage IIIC Intraocular MelanomaStage IIIC MelanomaStage IV Intraocular MelanomaStage IV Melanoma

Outcome Measures

Primary Outcomes (1)

  • Immunologic response defined as either an enzyme-linked immunosorbent spot (ELISPOT) response or a tetramer response for at least one peptide

    26 weeks

Secondary Outcomes (3)

  • Toxicities of the vaccine preparation graded using Common Toxicity Criteria (CTC)

    Up to 3 years

  • Time to relapse

    Up to 3 years

  • Overall survival

    Up to 3 years

Study Arms (2)

Cohort I (melanoma peptide vaccine, Montanide ISA-51)

EXPERIMENTAL

Patients receive multi-epitope peptide melanoma peptide vaccine with incomplete Freund's adjuvant and agatolimod sodium SC at 0, 2, 4, 6, 8, 10, 14, 18, 22, 26, 38, and 50 weeks and then every six months for two years for up to 16 vaccinations in the absence of disease progression or unacceptable toxicity.

Biological: gp100 antigenBiological: tyrosinase peptideBiological: recombinant MAGE-3.1 antigenBiological: multi-epitope melanoma peptide vaccineBiological: incomplete Freund's adjuvantDrug: agatolimod sodiumOther: laboratory biomarker analysis

Cohort II (melanoma peptide vaccine, Montanide ISA 51 VG)

EXPERIMENTAL

Patients receive multi-epitope peptide melanoma peptide vaccine with Montanide ISA 51 VG and agatolimod sodium SC at 0, 2, 4, 6, 8, 10, 14, 18, 22, 26, 38, and 50 weeks and then every six months for two years for up to 16 vaccinations in the absence of disease progression or unacceptable toxicity.

Biological: gp100 antigenBiological: tyrosinase peptideBiological: recombinant MAGE-3.1 antigenBiological: multi-epitope melanoma peptide vaccineDrug: Montanide ISA 51 VGDrug: agatolimod sodiumOther: laboratory biomarker analysis

Interventions

gp100 antigenBIOLOGICAL

Given SC

Also known as: gp100
Cohort I (melanoma peptide vaccine, Montanide ISA-51)Cohort II (melanoma peptide vaccine, Montanide ISA 51 VG)
tyrosinase peptideBIOLOGICAL

Given SC

Also known as: TYRP
Cohort I (melanoma peptide vaccine, Montanide ISA-51)Cohort II (melanoma peptide vaccine, Montanide ISA 51 VG)
recombinant MAGE-3.1 antigenBIOLOGICAL

Given SC

Also known as: MAGE-3, MAGE-3.1, MAGEA3
Cohort I (melanoma peptide vaccine, Montanide ISA-51)Cohort II (melanoma peptide vaccine, Montanide ISA 51 VG)
multi-epitope melanoma peptide vaccineBIOLOGICAL

Given SC

Also known as: MULTI-EP MP VAC
Cohort I (melanoma peptide vaccine, Montanide ISA-51)Cohort II (melanoma peptide vaccine, Montanide ISA 51 VG)
incomplete Freund's adjuvantBIOLOGICAL

Given SC

Also known as: IFA, ISA-51, Montanide ISA 51
Cohort I (melanoma peptide vaccine, Montanide ISA-51)
Montanide ISA 51 VGDRUG

Given SC

Cohort II (melanoma peptide vaccine, Montanide ISA 51 VG)
agatolimod sodiumDRUG

Given SC

Also known as: CpG 7909, PF-3512676
Cohort I (melanoma peptide vaccine, Montanide ISA-51)Cohort II (melanoma peptide vaccine, Montanide ISA 51 VG)
laboratory biomarker analysisOTHER

Correlative studies

Cohort I (melanoma peptide vaccine, Montanide ISA-51)Cohort II (melanoma peptide vaccine, Montanide ISA 51 VG)

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Stages IIC, III and IV cutaneous, or mucosal melanoma or stages III/IV ocular melanoma that have been completely resected; those rendered disease-free by radiation or systemic chemotherapy and/or immune therapy will also be eligible; patients must be entered within 12 months of disease-free status
  • Patients must be positive for at least one of human leukocyte antigen (HLA) A1, A3/A11 typed by a standard deoxyribonucleic acid (DNA)-polymerase chain reaction (PCR) assay, and HLA-B44 status must be known; patients who are B44 positive but do not express A1, A3 or A11 are not eligible for this trial
  • Tumor tissue must be available for analysis of gp100 and tyrosinase expression by immunohistochemistry; positive staining for at least one antigen will be an eligibility criteria for this trial
  • Serum creatinine of 2.0 mg/dl or less
  • Total bilirubin of 2.0 mg/dl or less
  • Serum glutamic oxaloacetic transaminase (SGOT)/serum glutamate pyruvate transaminase (SGPT) of 2.5 X institutional norm or less
  • Total white blood cell (WBC) of 3,000 or more
  • At least 1500 granulocytes
  • Hemoglobin of 9.0 gm/dl
  • Platelet count of 100,000 per cu mm
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Patients will be eligible for this trial if they have failed alpha-interferon, if it is felt to be contraindicated due to a pre-existing medical or psychiatric condition or if they have refused treatment with it
  • Ability to read, understand and willingness to sign an institutional review board (IRB)-approved informed consent

You may not qualify if:

  • Who are undergoing or have undergone in the past month any other therapy for their cancer, including radiation therapy and adjuvant therapy; six weeks must have elapsed for nitrosoureas
  • Have major systemic infections like pneumonia or sepsis, coagulation or bleeding disorders, or other major medical illnesses of the gastrointestinal, cardiovascular or respiratory systems
  • Who require steroid therapy or have been treated with steroids within 4 weeks of starting the trial
  • Who are pregnant or lactating, since the risk of autoimmune reactivity to tyrosinase or gp100 is felt to present a risk to the fetus or a breast feeding infant
  • Who are known to be positive for hepatitis B surface antigen (BsAg), Hepatitis C antibody or human immunodeficiency virus (HIV) antibody; since cells removed for ex vivo handling and tissue culture cannot be virus positive, and the effects of 7909 might be detrimental to HIV positive patients, patients positive for the above viruses will not be treated on this trial
  • Who have had a known allergic reaction to Montanide ISA 51 or ISA 51 VG
  • Who have a prior history of uveitis, autoimmune inflammatory eye disease or other autoimmune diseases other than vitiligo or controlled thyroiditis
  • Who have had another malignancy within the last three years with the exception of squamous or basal carcinoma of the skin or carcinoma in situ of the cervix that have been treated with curative intent
  • Who have previously received any of the peptides in the vaccine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern California

Los Angeles, California, 90033-0804, United States

Location

MeSH Terms

Conditions

Uveal MelanomaMelanoma

Interventions

gp100 Melanoma AntigenMAGEA3 protein, humanincomplete Freund's adjuvantmontanide ISA 51ProMune

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasUveal NeoplasmsEye NeoplasmsNeoplasms by SiteEye DiseasesUveal DiseasesSkin NeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Membrane ProteinsProteinsAmino Acids, Peptides, and ProteinsMelanoma-Specific AntigensNeoplasm ProteinsAntigens, NeoplasmAntigensBiological Factors

Study Officials

  • Jeffrey Weber

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2004

First Posted

June 11, 2004

Study Start

May 1, 2004

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

May 22, 2014

Record last verified: 2014-05

Locations

US(1)