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Vaccine Therapy and Sargramostim With or Without Docetaxel in Treating Patients With Metastatic Lung Cancer or Metastatic Colorectal Cancer

NCT00088933 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2014-03-31

No results posted yet for this study

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.

Conditions

  • Extensive Stage Small Cell Lung Cancer
  • Recurrent Colon Cancer
  • Recurrent Non-small Cell Lung Cancer
  • Recurrent Rectal Cancer
  • Recurrent Small Cell Lung Cancer
  • Stage IV Colon Cancer
  • Stage IV Non-small Cell Lung Cancer
  • Stage IV Rectal Cancer

Interventions

DRUG

recombinant fowlpox-CEA(6D)/TRICOM vaccine

Given intradermally

DRUG

recombinant vaccinia-CEA(6D)-TRICOM vaccine

Given intradermally

DRUG

docetaxel

Given IV

DRUG

sargramostim

Given subcutaneously

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • John Marshall · Lombardi Comprehensive Cancer Center at Georgetown University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-06-30
Primary Completion
2007-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00088933 on ClinicalTrials.gov