NCT00088933

Brief Summary

This randomized phase I trial studies the side effects, best way to give, and best dose of docetaxel when given together with vaccine therapy and sargramostim in treating patients with metastatic lung cancer or metastatic colorectal cancer. Vaccines may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim increase the number of immune cells found in bone marrow and peripheral blood. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining vaccine therapy and sargramostim with docetaxel may kill more tumor cells.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
60

participants targeted

Target at 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

June 1, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 5, 2004

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Last Updated

March 31, 2014

Status Verified

March 1, 2013

Enrollment Period

3.4 years

First QC Date

August 4, 2004

Last Update Submit

March 28, 2014

Conditions

Extensive Stage Small Cell Lung CancerRecurrent Colon CancerRecurrent Non-small Cell Lung CancerRecurrent Rectal CancerRecurrent Small Cell Lung CancerStage IV Colon CancerStage IV Non-small Cell Lung CancerStage IV Rectal Cancer

Outcome Measures

Primary Outcomes (3)

  • Anti-tumor response rate defined as the number of patients in each arm achieving a complete or partial response or stable disease divided by the total number of patients on each arm measured according to standard RECIST guidelines

    Up to 6 years

  • Immune response defined as the numbers of patients who achieve an ELISPOT result of 1/30,000 or higher divided by the number of HLA-A2 positive individuals for each treatment arm

    The actual ELISPOT will be recorded for each individual and will be presented graphically.

    Up to 6 years

  • Number of patients experiencing each of the toxicities by grade for each treatment arm

    Up to 6 years

Secondary Outcomes (1)

  • Average quantity of circulating CEA cells determined by quantitative real time RT-PCR

    Up to 6 years

Study Arms (6)

Arm I

EXPERIMENTAL

Three weeks after treatment with vaccinia-CEA-TRICOM vaccine, patients receive fowlpox-CEA-TRICOM vaccine SC on day 1 and GM-CSF SC into each vaccination site on days 1-4.

Drug: recombinant fowlpox-CEA(6D)/TRICOM vaccineDrug: recombinant vaccinia-CEA(6D)-TRICOM vaccineDrug: sargramostim

Arm II

EXPERIMENTAL

Patients receive fowlpox-CEA-TRICOM vaccine and GM-CSF as in arm I and lower-dose docetaxel IV over 30 minutes on days 1 and 8.

Drug: recombinant fowlpox-CEA(6D)/TRICOM vaccineDrug: recombinant vaccinia-CEA(6D)-TRICOM vaccineDrug: docetaxelDrug: sargramostim

Arm III

EXPERIMENTAL

Patients receive fowlpox-CEA-TRICOM vaccine and GM-CSF as in arm I and standard-dose docetaxel IV over 30 minutes on days 1 and 8.

Drug: recombinant fowlpox-CEA(6D)/TRICOM vaccineDrug: recombinant vaccinia-CEA(6D)-TRICOM vaccineDrug: docetaxelDrug: sargramostim

Arm IV

EXPERIMENTAL

Patients receive fowlpox-CEA-TRICOM vaccine and GM-CSF as in arm I and full-dose docetaxel IV over 1 hour on day 1.

Drug: recombinant fowlpox-CEA(6D)/TRICOM vaccineDrug: recombinant vaccinia-CEA(6D)-TRICOM vaccineDrug: docetaxelDrug: sargramostim

Arm V

EXPERIMENTAL

Patients receive full-dose docetaxel IV over 1 hour on day 1, fowlpox-CEA-TRICOM vaccine SC on day 8, and GM-CSF SC into each vaccination site on days 8-11.

Drug: recombinant fowlpox-CEA(6D)/TRICOM vaccineDrug: recombinant vaccinia-CEA(6D)-TRICOM vaccineDrug: docetaxelDrug: sargramostim

Arm VI

EXPERIMENTAL

Patients receive full-dose docetaxel as in arm V, fowlpox-CEA-TRICOM vaccine SC on day 15, and GM-CSF SC into each vaccination site on days 15-18.

Drug: recombinant fowlpox-CEA(6D)/TRICOM vaccineDrug: recombinant vaccinia-CEA(6D)-TRICOM vaccineDrug: docetaxelDrug: sargramostim

Interventions

recombinant fowlpox-CEA(6D)/TRICOM vaccineDRUG

Given intradermally

Also known as: fowlpox-CEA-B7-1/ICAM-1/LFA-3, rF-CEA(6D)TRICOM
Arm IArm IIArm IIIArm IVArm VArm VI
recombinant vaccinia-CEA(6D)-TRICOM vaccineDRUG

Given intradermally

Also known as: rV-CEA(6D)-TRICOM
Arm IArm IIArm IIIArm IVArm VArm VI
docetaxelDRUG

Given IV

Also known as: RP 56976, Taxotere, TXT
Arm IIArm IIIArm IVArm VArm VI
sargramostimDRUG

Given subcutaneously

Also known as: GM-CSF, Leukine, Prokine
Arm IArm IIArm IIIArm IVArm VArm VI

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed lung OR colorectal cancer
  • Incurable metastatic disease
  • Currently available standard treatment not likely to offer a survival advantage or result in superior palliation
  • Evaluable disease by radiograph
  • Tumor must currently express carcinoembryonic antigen (CEA) by immunohistochemistry OR CEA \>= 10 ng/mL at any point during disease course
  • No clinically active brain metastases
  • Must have had first- and second-line treatment OR declined second-line treatment (part I only)
  • Patients with colon cancer must have had or have been offered treatment with oxaliplatin (part I only)
  • ECOG 0-1
  • Life expectancy of at least 4 months
  • Absolute neutrophil count \>= 1,500/mm\^3
  • WBC \>= 3,000/mm\^3
  • Platelet count \>= 100,000/mm\^3
  • Bilirubin normal
  • Meets 1 of the following criteria:
  • +50 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lombardi Comprehensive Cancer Center at Georgetown University

Washington D.C., District of Columbia, 20057, United States

Location

MeSH Terms

Conditions

Colonic NeoplasmsCarcinoma, Non-Small-Cell LungRectal NeoplasmsSmall Cell Lung Carcinoma

Interventions

DocetaxelsargramostimGranulocyte-Macrophage Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • John Marshall

    Lombardi Comprehensive Cancer Center at Georgetown University

    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

August 4, 2004

First Posted

August 5, 2004

Study Start

June 1, 2004

Primary Completion

November 1, 2007

Last Updated

March 31, 2014

Record last verified: 2013-03

Locations

US(1)