NCT00006243

Brief Summary

This randomized pilot clinical trial studies vaccine therapy and sargramostim in treating patients with stage IV malignant melanoma. Vaccines made from melanoma peptides or antigens may help the body build an effective immune response to kill tumor cells. Colony-stimulating factors, such as sargramostim, increase the number of white blood cells and platelets found in bone marrow or peripheral blood. Giving vaccine therapy together with sargramostim may be an effective treatment for malignant melanoma

Trial Health

80
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

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

First Submitted

Initial submission to the registry

September 11, 2000

Completed
20 days until next milestone

Study Start

First participant enrolled

October 1, 2000

Completed
2.6 years until next milestone

First Posted

Study publicly available on registry

May 22, 2003

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Last Updated

January 25, 2013

Status Verified

January 1, 2013

Enrollment Period

5.6 years

First QC Date

September 11, 2000

Last Update Submit

January 24, 2013

Conditions

Recurrent MelanomaStage IV Melanoma

Outcome Measures

Primary Outcomes (1)

  • Changes in tumor antigen peptide specific immune responses

    Plots of the percent changes in these factors from their pretreatment levels against time will be constructed.

    Baseline and 24 weeks

Secondary Outcomes (2)

  • Number and severity of hematologic and non-hematologic toxicities observed using the Common Toxicity Criteria (CTC) version 2.0

    Up to 3 years

  • Proportion of objective responses (complete response [CR] and partial response [PR]) observed

    Up to 3 years

Study Arms (3)

Arm I (vaccine therapy)

EXPERIMENTAL

Patients receive tyrosinase peptide, MART-1:27-35 peptide vaccine, and gp100 antigen admixed in incomplete Freund's adjuvant SC on day 1 of weeks 0, 3, 6, 9, 12, and 24.

Biological: tyrosinase peptideBiological: MART-1:27-35 peptide vaccineBiological: gp100 antigenBiological: incomplete Freund's adjuvantOther: laboratory biomarker analysis

Arm II (vaccine therapy and lower-dose sargramostim)

EXPERIMENTAL

Patients receive tyrosinase peptide, MART-1:27-35 peptide vaccine, and gp100 antigen admixed in incomplete Freund's adjuvant SC and lower-dose sargramostim SC on day 1 of weeks 0, 3, 6, 9, 12, and 24.

Biological: tyrosinase peptideBiological: MART-1:27-35 peptide vaccineBiological: gp100 antigenBiological: incomplete Freund's adjuvantBiological: sargramostimOther: laboratory biomarker analysis

Arm III (vaccine therapy and higher-dose sargramostim)

EXPERIMENTAL

Patients receive tyrosinase peptide, MART-1:27-35 peptide vaccine, and gp100 antigen admixed in incomplete Freund's adjuvant SC and higher-dose sargramostim SC on day 1 of weeks 0, 3, 6, 9, 12, and 24.

Biological: tyrosinase peptideBiological: MART-1:27-35 peptide vaccineBiological: gp100 antigenBiological: incomplete Freund's adjuvantBiological: sargramostimOther: laboratory biomarker analysis

Interventions

tyrosinase peptideBIOLOGICAL

Given SC

Also known as: TYRP
Arm I (vaccine therapy)Arm II (vaccine therapy and lower-dose sargramostim)Arm III (vaccine therapy and higher-dose sargramostim)
MART-1:27-35 peptide vaccineBIOLOGICAL

Given SC

Arm I (vaccine therapy)Arm II (vaccine therapy and lower-dose sargramostim)Arm III (vaccine therapy and higher-dose sargramostim)
gp100 antigenBIOLOGICAL

Given SC

Also known as: gp100
Arm I (vaccine therapy)Arm II (vaccine therapy and lower-dose sargramostim)Arm III (vaccine therapy and higher-dose sargramostim)
incomplete Freund's adjuvantBIOLOGICAL

Given SC

Also known as: IFA, ISA-51, Montanide ISA 51
Arm I (vaccine therapy)Arm II (vaccine therapy and lower-dose sargramostim)Arm III (vaccine therapy and higher-dose sargramostim)
sargramostimBIOLOGICAL

Given SC

Also known as: GM-CSF, Leukine, Prokine
Arm II (vaccine therapy and lower-dose sargramostim)Arm III (vaccine therapy and higher-dose sargramostim)
laboratory biomarker analysisOTHER

Correlative studies

Arm I (vaccine therapy)Arm II (vaccine therapy and lower-dose sargramostim)Arm III (vaccine therapy and higher-dose sargramostim)

Eligibility Criteria

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

You may qualify if:

  • Human leukocyte antigen (HLA)-A2 positive
  • Histologic proof of stage IV malignant melanoma with measurable disease
  • Absolute neutrophil count (ANC) \>= 1500
  • Platelets (PLT) \>= 100,000
  • Alkaline phosphatase (Alk phos) =\< 3 x upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) =\< 3 x ULN
  • Creatinine (Creat) =\< 1.5 x ULN
  • Hemoglobin (Hgb) \> 9.0
  • Ability to provide informed consent
  • Willingness to return to a Mayo Clinic institution for follow-up
  • Life expectancy \>= 12 weeks
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2

You may not qualify if:

  • Uncontrolled or current infection
  • Prior immunization with differentiation antigen peptides
  • Known standard therapy for the patient's disease that is potentially curative or proven capable of extending life expectancy
  • Any of the following prior therapies:
  • Chemotherapy =\< 4 weeks
  • Mitomycin C/nitrosoureas =\< 6 weeks
  • Immunotherapy =\<4 weeks
  • Biologic therapy =\< 4 weeks
  • Radiation therapy =\< 4 weeks
  • Radiation to \> 25% of bone marrow
  • Failure to fully recover from effects of prior chemotherapy regardless of interval since last treatment
  • New York Heart Association classification III or IV
  • Seizure disorder
  • Any of the following:
  • Pregnant women
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

gp100 Melanoma Antigenincomplete Freund's adjuvantmontanide ISA 51sargramostimGranulocyte-Macrophage Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Membrane ProteinsProteinsAmino Acids, Peptides, and ProteinsMelanoma-Specific AntigensNeoplasm ProteinsAntigens, NeoplasmAntigensBiological FactorsColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptides

Study Officials

  • Svetomir Markovic

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2000

First Posted

May 22, 2003

Study Start

October 1, 2000

Primary Completion

May 1, 2006

Last Updated

January 25, 2013

Record last verified: 2013-01

Locations

US(1)