NCT00028496

Brief Summary

Phase I trial to study the effectiveness of vaccine therapy with or without sargramostim in treating patients who have advanced or metastatic cancer. Vaccines may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. Combining vaccine therapy with sargramostim may make tumor cells more sensitive to the vaccine and may kill more tumor cells

Trial Health

80
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P50-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

November 1, 2001

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2002

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
Last Updated

January 25, 2013

Status Verified

January 1, 2013

Enrollment Period

4 years

First QC Date

January 4, 2002

Last Update Submit

January 24, 2013

Conditions

Adenocarcinoma of the ColonAdenocarcinoma of the GallbladderAdenocarcinoma of the PancreasAdenocarcinoma of the RectumAdult Primary Hepatocellular CarcinomaAdvanced Adult Primary Liver CancerCholangiocarcinoma of the GallbladderDiffuse Adenocarcinoma of the StomachIntestinal Adenocarcinoma of the StomachMale Breast CancerMixed Adenocarcinoma of the StomachOvarian Endometrioid AdenocarcinomaPaget Disease of the Breast With Intraductal CarcinomaPaget Disease of the Breast With Invasive Ductal CarcinomaRecurrent Adult Primary Liver CancerRecurrent Breast CancerRecurrent Colon CancerRecurrent Gallbladder CancerRecurrent Gastric CancerRecurrent Malignant Testicular Germ Cell TumorRecurrent Pancreatic CancerRecurrent Rectal CancerRecurrent Salivary Gland CancerSalivary Gland AdenocarcinomaStage II Malignant Testicular Germ Cell TumorStage II Pancreatic CancerStage III Colon CancerStage III Gastric CancerStage III Malignant Testicular Germ Cell TumorStage III Pancreatic CancerStage III Rectal CancerStage III Salivary Gland CancerStage IIIA Breast CancerStage IIIB Breast CancerStage IV Breast CancerStage IV Colon CancerStage IV Gastric CancerStage IV Pancreatic CancerStage IV Rectal CancerStage IV Salivary Gland CancerThyroid Gland Medullary CarcinomaUnresectable Gallbladder Cancer

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerated dose of recombinant fowlpox-CEA(6D)/TRICOM vaccine determined by dose-limiting toxicities graded according to NCI Common Toxicity Criteria, version 2.0

    56 days

Study Arms (1)

Treatment (vaccine therapy, sargramostim, vaccine adjuvant)

EXPERIMENTAL

The first three cohorts of 3-12 patients receive escalating doses of recombinant fowlpox-CEA-TRICOM vaccine (fCEA-TRI) until the maximum tolerated dose (MTD) is determined. fCEA-TRI is administered intradermally every 2 weeks for 4 doses and then every 2 months thereafter (beginning on day 56) in the absence of disease progression or unacceptable toxicity. The fourth and fifth cohorts of 6 patients receive fCEA-TRI at the MTD in the same manner as the first three cohorts combined with escalating doses of sargramostim (GM-CSF). GM-CSF is administered subcutaneously once daily beginning on the day of each vaccination and continuing for a total of 4 days. The sixth through eighth cohorts of 6 patients receive fCEA-TRI at the MTD in the same manner as the first three cohorts combined with escalating doses of recombinant fowlpox-GM-CSF (rF-GM-CSF).

Biological: recombinant fowlpox-CEA(6D)/TRICOM vaccineBiological: sargramostimBiological: recombinant fowlpox GM-CSF vaccine adjuvant

Interventions

recombinant fowlpox-CEA(6D)/TRICOM vaccineBIOLOGICAL

Given intradermally

Also known as: fowlpox-CEA-B7-1/ICAM-1/LFA-3, rF-CEA(6D)TRICOM
Treatment (vaccine therapy, sargramostim, vaccine adjuvant)
sargramostimBIOLOGICAL

Given subcutaneously

Also known as: GM-CSF, Leukine, Prokine
Treatment (vaccine therapy, sargramostim, vaccine adjuvant)
recombinant fowlpox GM-CSF vaccine adjuvantBIOLOGICAL

Given intradermally

Also known as: fowlpox-GM-CSF, fowlpox-sargramostim, rf-GM-CSF, rf-sargramostim
Treatment (vaccine therapy, sargramostim, vaccine adjuvant)

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed adenocarcinoma that failed standard curative options and for which no standard palliative options are required within the next 8weeks
  • Advanced or metastatic disease
  • Recurrent or unresectable disease
  • Microscopic metastatic disease confirmed by surgical exploration allowed
  • CEA expression by immunohistochemistry
  • Circulating CEA greater than 5 ng/mL
  • HLA phenotyping required
  • HLA phenotyping must be repeated for patients who have undergone allogeneic bone marrow transplantation
  • No clinically symptomatic brain metastases
  • Patients with brain metastases who have completed palliative radiotherapy and have discontinued steroids are eligible
  • Hormone receptor status:
  • Not specified
  • Male or female
  • Performance status - ECOG 0-1
  • WBC at least 3,000/mm\^3
  • +56 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111-2497, United States

Location

MeSH Terms

Conditions

Colonic NeoplasmsRectal NeoplasmsCarcinoma, HepatocellularBreast Neoplasms, MaleBreast NeoplasmsGallbladder NeoplasmsStomach NeoplasmsTesticular NeoplasmsPancreatic NeoplasmsSalivary Gland NeoplasmsCarcinoma, Medullary

Interventions

sargramostimGranulocyte-Macrophage Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeLiver NeoplasmsLiver DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBiliary Tract NeoplasmsBiliary Tract DiseasesGallbladder DiseasesStomach DiseasesEndocrine Gland NeoplasmsGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesEndocrine System DiseasesTesticular DiseasesGonadal DisordersPancreatic DiseasesMouth NeoplasmsHead and Neck NeoplasmsMouth DiseasesStomatognathic DiseasesSalivary Gland DiseasesCarcinoma, NeuroendocrineNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Ductal, Lobular, and MedullaryNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Margaret von Mehren

    Fox Chase 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

January 4, 2002

First Posted

January 27, 2003

Study Start

November 1, 2001

Primary Completion

November 1, 2005

Last Updated

January 25, 2013

Record last verified: 2013-01

Locations

US(1)