NCT00087373

Brief Summary

Vaccines may make the body build an immune response to kill tumor cells. Injecting a vaccine directly into a tumor may cause a stronger immune response and kill more tumor cells. This phase II trial is studying how well vaccine therapy works in treating patients with metastatic melanoma.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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
1 month until next milestone

First Submitted

Initial submission to the registry

July 8, 2004

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 12, 2004

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
Last Updated

June 9, 2014

Status Verified

December 1, 2012

Enrollment Period

1.7 years

First QC Date

July 8, 2004

Last Update Submit

June 6, 2014

Conditions

Recurrent MelanomaStage IV Melanoma

Outcome Measures

Primary Outcomes (2)

  • Local response defined as complete response (CR), a partial response (PR) stable disease (SD), or progressive disease (PD) in the injected lesion according to RECIST criteria

    Up to 15 years

  • Overall clinical response (CR or PR) as measured by RECIST criteria

    Up to 15 years

Secondary Outcomes (3)

  • Change in mRNA expression of B7-1, LFA-3, and/or ICAM-1in the tumor microenvironment

    Baseline and week 10

  • Changes in tumor associated T cells

    Baseline and week 10

  • Time to tumor progression

    Up to 15 years

Study Arms (1)

Treatment (recombinant fowlpox-TRICOM vaccine)

EXPERIMENTAL

Patients receive fowlpox-TRICOM intratumorally on day 1 of weeks 1, 4, and 7 (maximum of 3 injections for a single lesion) (course 1). After 3 injections (course 1), patients with stable or responding disease receive additional injections into new lesions following the same schedule as above. Treatment repeats every 9 weeks for a maximum total of 9 injections (3 injections total into a maximum of 3 different tumors) (total of 3 courses) in the absence of disease progression or unacceptable toxicity

Biological: recombinant fowlpox-TRICOM vaccineOther: laboratory biomarker analysis

Interventions

recombinant fowlpox-TRICOM vaccineBIOLOGICAL

Given intratumorally

Also known as: rF-TRICOM (B7.1.iCAM1-LFA3-Fowlpox)
Treatment (recombinant fowlpox-TRICOM vaccine)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (recombinant fowlpox-TRICOM vaccine)

Eligibility Criteria

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

You may qualify if:

  • Histologically or cytologically confirmed melanoma
  • Stage IV disease
  • Measurable disease
  • At least 1 cutaneous or lymph node mass ≥ 1 cm AND amenable to biopsy and percutaneous injection AND can be accurately measured with standard calipers
  • Must be tested for expression of HLA-A2 prior to study
  • Must have 1 of the following criteria:
  • Circulating melanoma-specific CD8-positive T cells against ≥ 1 defined antigen (Melan-A, gp100 antigen, tyrosinase, MAGE-A10, Trp-2, or NA17) as measured by tetramer or ELISpot directly ex-vivo or after a 10 day in vitro expansion
  • Detectable intratumoral T cells measured in the index lesion that is to be injected with rF-TRICOMTM by immunohistochemistry (IHC) for CD4, CD8 or another T cell marker, or by real time RT-PCR for CD8a, CD4, or other T cell transcripts
  • No untreated or edematous brain metastases or leptomeningeal disease
  • Treated CNS disease allowed provided patient remains stable off corticosteroid therapy
  • Performance status - Karnofsky 70-100%
  • More than 12 weeks
  • WBC ≥ 3,000/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • No uncontrolled bleeding disorder that would increase the risk of bleeding from the injected lesion
  • +43 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Melanoma

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

Study Officials

  • Thomas Gajewski

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2004

First Posted

July 12, 2004

Study Start

June 1, 2004

Primary Completion

February 1, 2006

Last Updated

June 9, 2014

Record last verified: 2012-12

Locations

US(1)