NCT00217373

Brief Summary

This phase I trial is studying the side effects and best dose of interferon alfa-2b when given together with vaccine therapy and GM-CSF in treating patients with locally advanced or metastatic cancer that makes CEA. Vaccines made from a gene-modified virus may help the body build an effective immune response to kill cancer cells that make carcinoembryonic antigen (CEA). Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop cancer cells from growing. Interferon alfa-2b may interfere with the growth of cancer cells and slow cancer growth. Giving vaccine therapy together with GM-CSF and interferon alfa-2b may kill more cancer cells that make CEA.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2005

Longer than P75 for phase_1

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, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

April 20, 2015

Status Verified

December 1, 2014

Enrollment Period

7.6 years

First QC Date

September 20, 2005

Last Update Submit

April 17, 2015

Conditions

Adult Solid Neoplasm

Outcome Measures

Primary Outcomes (1)

  • MTD of IFN-alpha-2b, defined as the dose level one level beneath that dose at which 2 or more of 6 patients showed DLT, graded according to NCI CTCAE version 4.0

    Up to 112 days

Secondary Outcomes (2)

  • Incidence of adverse events, graded according to NCI CTCAE version 4.0

    Up to 15 years

  • Response to treatment, evaluated using the new international criteria proposed by the RECIST Committee

    Up to 15 years

Study Arms (1)

Arm I

EXPERIMENTAL

COURSE I: Patients receive recombinant vaccinia-CEA(6D)-TRICOM vaccine SC on day 1. Patients also receive sargramostim (GM-CSF) SC on days 1-4 and IFN-α-2b\* SC on days 9, 11, and 13. COURSES II-IV: Patients receive recombinant fowlpox-CEA(6D)-TRICOM vaccine SC on day 1. Patients also receive GM-CSF as in course 1 and IFN-α-2b\* SC on days 1, 3, and 5. NOTE: \*The initial cohort of 6 patients does not receive IFN-α-2b. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. After 4 courses, patients who do not have progressive disease or unacceptable toxicity may receive recombinant fowlpox-CEA (6D)-TRICOM vaccine, GM-CSF, and IFN-α-2b every 28 days for 2 more courses and then every 3 months for up to 2 years.

Biological: Recombinant Fowlpox-CEA(6D)/TRICOM VaccineBiological: Recombinant Interferon Alfa-2bBiological: Recombinant Vaccinia-CEA(6D)-TRICOM VaccineBiological: Sargramostim

Interventions

Recombinant Fowlpox-CEA(6D)/TRICOM VaccineBIOLOGICAL

Given SC

Also known as: fowlpox-CEA-B7.1/ICAM-1/LFA-3, Recombinant Fowlpox-CEA-TRICOM Vaccine, rF-CEA(6D)TRICOM
Arm I
Recombinant Interferon Alfa-2bBIOLOGICAL

Given SC

Also known as: Alfatronol, Glucoferon, Heberon Alfa, IFN alpha-2B, Interferon alfa 2b, INTERFERON ALFA-2B, Interferon Alpha-2b, Intron A, Sch 30500, Urifron, Viraferon
Arm I
Recombinant Vaccinia-CEA(6D)-TRICOM VaccineBIOLOGICAL

Given SC

Also known as: rV-CEA(6D)-TRICOM, Vaccinia-CEA-TRICOM Vaccine
Arm I
SargramostimBIOLOGICAL

Given SC

Also known as: 23-L-Leucinecolony-Stimulating Factor 2, DRG-0012, Leukine, Prokine, rhu GM-CFS, Sagramostim, Sargramostatin
Arm I

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed carcinoembryonic antigen (CEA)-expressing carcinoma
  • Metastatic or locally advanced disease
  • Tumor accessible for biopsy
  • Must have received ≥ 1 prior systemic regimen for metastatic disease
  • No known brain metastases
  • Performance status - ECOG 0-2
  • Performance status - Karnofsky 60-100%
  • More than 6 months
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Bilirubin ≤ 2.0 times upper limit of normal (ULN)
  • AST and ALT ≤ 4.0 times ULN
  • Hepatitis B negative
  • Hepatitis C negative
  • Creatinine ≤ 1.96 mg/dL
  • +47 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Interventions

IntronsInterferon alpha-2sargramostimColony-Stimulating Factors

Intervention Hierarchy (Ancestors)

DNA, IntergenicGenome ComponentsGenomeGenetic StructuresGenetic PhenomenaGene ComponentsGenesInterferon-alphaInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth Factors

Study Officials

  • William Carson

    Ohio State University Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2005

First Posted

September 22, 2005

Study Start

June 1, 2005

Primary Completion

January 1, 2013

Study Completion

March 1, 2015

Last Updated

April 20, 2015

Record last verified: 2014-12

Locations

US(1)