Denileukin Diftitox Followed by Vaccine Therapy in Treating Patients With Metastatic Cancer

NCT00128622 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2012-11-12

No results posted yet for this study

Summary

RATIONALE: Combinations of biological substances in denileukin diftitox may be able to carry cancer-killing substances directly to the cancer cells. Vaccines made from a gene-modified virus and a person's white blood cells may help the body build an effective immune response to kill cancer cells. Giving denileukin diftitox together with vaccine therapy may kill more cancer cells.

PURPOSE: This phase I trial is studying the side effects of giving denileukin diftitox together with vaccine therapy in treating patients with metastatic cancer that expresses carcinoembryonic antigen.

Conditions

Interventions

BIOLOGICAL

denileukin diftitox

BIOLOGICAL

recombinant fowlpox-CEA(6D)/TRICOM vaccine

BIOLOGICAL

therapeutic autologous dendritic cells

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • H. Kim Lyerly

    lead OTHER

Principal Investigators

  • Michael A. Morse, MD · Duke Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2007-03-31
Completion
2009-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT00128622 on ClinicalTrials.gov