NCT00089063

Brief Summary

This randomized phase II trial is studying vaccine therapy and sargramostim to see how well they work compared to vaccine therapy alone in treating patients who have undergone surgery for stage IIB, stage IIC, stage III, or stage IV melanoma. Vaccines made from peptides may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim increase the number of immune cells found in bone marrow or peripheral blood. Combining vaccine therapy with sargramostim may make a stronger immune response.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 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

June 1, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 5, 2004

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

April 15, 2015

Status Verified

October 1, 2013

Enrollment Period

3 years

First QC Date

August 4, 2004

Last Update Submit

April 14, 2015

Conditions

Ciliary Body and Choroid Melanoma, Medium/Large SizeExtraocular Extension MelanomaIris MelanomaStage IIB MelanomaStage IIC MelanomaStage IIIA MelanomaStage IIIB MelanomaStage IIIC MelanomaStage IV Melanoma

Outcome Measures

Primary Outcomes (2)

  • Immune response

    Summarized using means and confidence intervals (after transformation to render the data compatible with the assumptions of the normal distribution).

    Baseline

  • Immune response

    Summarized using means and confidence intervals (after transformation to render the data compatible with the assumptions of the normal distribution).

    Week 106

Secondary Outcomes (2)

  • Disease-free survival

    Up to 2 years

  • Overall survival

    Up to 2 years

Study Arms (2)

Arm I (vaccine therapy)

EXPERIMENTAL

Patients receive vaccination comprising tyrosinase peptide, gp100 antigen, and MART-1 antigen emulsified with Montanide ISA-51 and ISA-51 VG SC on day 1 of weeks 0, 26, 52, 78, and 104 (total of 5 vaccinations).

Biological: tyrosinase peptideBiological: gp100 antigenBiological: MART-1 antigenBiological: incomplete Freund's adjuvantDrug: Montanide ISA 51 VGOther: laboratory biomarker analysis

Arm II (vaccine therapy, sargramostim)

EXPERIMENTAL

Patients receive vaccination comprising tyrosinase peptide, gp100 antigen, and MART-1 antigen emulsified with Montanide ISA-51 and ISA-51 VG as in arm I. Patients also receive sargramostim (GM-CSF) SC on days 1-5 of weeks 0, 26, 52, 78, and 104.

Biological: tyrosinase peptideBiological: gp100 antigenBiological: MART-1 antigenBiological: incomplete Freund's adjuvantDrug: Montanide ISA 51 VGBiological: sargramostimOther: laboratory biomarker analysis

Interventions

tyrosinase peptideBIOLOGICAL

Given SC

Arm I (vaccine therapy)Arm II (vaccine therapy, sargramostim)
gp100 antigenBIOLOGICAL

Given SC

Arm I (vaccine therapy)Arm II (vaccine therapy, sargramostim)
MART-1 antigenBIOLOGICAL

Given SC

Arm I (vaccine therapy)Arm II (vaccine therapy, sargramostim)
incomplete Freund's adjuvantBIOLOGICAL

Given SC

Arm I (vaccine therapy)Arm II (vaccine therapy, sargramostim)
Montanide ISA 51 VGDRUG

Given SC

Arm I (vaccine therapy)Arm II (vaccine therapy, sargramostim)
sargramostimBIOLOGICAL

Given SC

Arm II (vaccine therapy, sargramostim)
laboratory biomarker analysisOTHER

Correlative studies

Arm I (vaccine therapy)Arm II (vaccine therapy, sargramostim)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who have completed protocol 10M-01-1 or 10M-00-4 are eligible for this study provided that
  • They have received all injections with evidence of an immune response
  • They have not experienced recurrence of the melanoma
  • Not more than twelve months have elapsed since the final injection on either protocol
  • They experienced no grade 3 or 4 toxicity attributed to the prior vaccine regimen
  • Serum creatinine of 2.0 mg/dl or less
  • Total bilirubin of 2.0 mg/dl or less
  • SGOT/SGPT of 2.5 X institutional norm or less
  • Total WBC of 3,000 or more
  • At least 1500 granulocytes
  • Hemoglobin of 9.0 gm/dl or more
  • Platelet count of 100,000 per cu mm. or more
  • 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 IRB-approved informed consent
  • +1 more criteria

You may not qualify if:

  • Who have undergone any other systemic therapy for their melanoma, including radiation therapy since completion of 10M-01-1 or 10M-00-4
  • 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 systemic, ocular or inhaled corticosteroids
  • Who are pregnant or lactating, since the risk of autoimmune reactivity to tyrosinase, MART-1 or gp100 is felt to present a risk to the fetus or a breast feeding infant; effective birth control for men and women is required during and for four months after the study is finished
  • Who are known to be positive for hepatitis BsAg, hepatitis C antibody or HIV antibody; since cells removed for ex vivo handling and tissue culture cannot be virus positive, and the effects of melanoma peptides 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 GM-CSF, Montanide ISA 51 (IFA) or any of the peptides included in this protocol
  • Who have a prior history of uveitis or autoimmune inflammatory eye disease, immune hemolytic anemia or other active autoimmune disease

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

MART-1 Antigenincomplete Freund's adjuvantmontanide ISA 51sargramostim

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)

Melanoma-Specific AntigensNeoplasm ProteinsProteinsAmino Acids, Peptides, and ProteinsAntigens, NeoplasmAntigensBiological Factors

Study Officials

  • Jeffrey Weber

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 4, 2004

First Posted

August 5, 2004

Study Start

June 1, 2004

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

April 15, 2015

Record last verified: 2013-10

Locations

US(1)