NCT00030693

Brief Summary

Randomized phase I trial to compare the effectiveness of two different vaccines given directly into the tumor in treating patients who have metastatic solid tumors. Vaccines may make the body build an immune response to kill tumor cells. Infusing the vaccine directly into a tumor may cause a stronger immune response and kill more tumor cells. It is not yet known which vaccine may be more effective in treating metastatic solid tumors

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
42

participants targeted

Target at P50-P75 for phase_1

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

December 1, 2001

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2002

Completed
12 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Last Updated

January 24, 2013

Status Verified

January 1, 2013

Enrollment Period

8.3 years

First QC Date

February 14, 2002

Last Update Submit

January 23, 2013

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (1)

  • Percentages of the DLTEs

    Will be summarized and compared between arms, doses, and disease groups using Fisher's exact test.

    12 weeks

Secondary Outcomes (3)

  • Proportion of patients with any response (CR, PR, or SD)

    12 weeks

  • Immune response

    12 weeks

  • Change in quality of life, assessed using the FACT-G survey of emotional and functional well being

    Baseline to 12 weeks

Study Arms (2)

Arm I (recombinant fowlpox-B7.1 vaccine)

EXPERIMENTAL

Patients receive rF-B7.1 vaccine intratumorally on day 1.

Biological: recombinant fowlpox-B7.1 vaccineOther: laboratory biomarker analysisProcedure: quality-of-life assessment

Arm II (recombinant fowlpox-TRICOM vaccine)

EXPERIMENTAL

Patients receive fowlpox-TRICOM vaccine intratumorally on day 1.

Biological: recombinant fowlpox-TRICOM vaccineOther: laboratory biomarker analysisProcedure: quality-of-life assessment

Interventions

recombinant fowlpox-B7.1 vaccineBIOLOGICAL

Given intratumorally

Also known as: rF-B7.1, rF-B7.1 vaccine
Arm I (recombinant fowlpox-B7.1 vaccine)
recombinant fowlpox-TRICOM vaccineBIOLOGICAL

Given intratumorally

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

Correlative studies

Arm I (recombinant fowlpox-B7.1 vaccine)Arm II (recombinant fowlpox-TRICOM vaccine)
quality-of-life assessmentPROCEDURE

Ancillary studies

Also known as: quality of life assessment
Arm I (recombinant fowlpox-B7.1 vaccine)Arm II (recombinant fowlpox-TRICOM vaccine)

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed metastatic unresectable solid tumors
  • Cutaneous, subcutaneous, lymph node, or visceral tumors that are accessible to imaging and injections
  • No standard therapy available
  • At least 1 unidimensionally measurable lesion
  • At least 20 mm for visceral lesions
  • At least 10 mm for cutaneous, subcutaneous, and nodal lesions
  • No untreated or edematous metastatic brain lesions
  • At least 6 weeks since prior surgery and/or radiotherapy for brain metastases and no evidence of disease or edema on CT scan or MRI
  • No ascites or pleural effusions
  • No leptomeningeal disease
  • Performance status - ECOG 0-1
  • More than 3 months
  • Absolute granulocyte count at least 3,000/mm\^3
  • Platelet count at least 100,000/mm\^3
  • No bleeding diathesis
  • +27 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

MeSH Terms

Interventions

rF-B7.1 vaccine

Study Officials

  • Howard Kaufman

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2002

First Posted

January 27, 2003

Study Start

December 1, 2001

Primary Completion

April 1, 2010

Last Updated

January 24, 2013

Record last verified: 2013-01

Locations

US(1)