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NCT00217373 · ClinicalTrials.gov registry record · Phase 1

Vaccine Therapy, GM-CSF, and Interferon Alfa-2b in Treating Patients With Locally Advanced or Metastatic Cancer That Expresses Carcinoembryonic Antigen (CEA)

A Phase 1 study of Adult Solid Neoplasm, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 1
Development phase
33
Enrollment target
1
Study location

NCT00217373 is a Phase 1 study of Adult Solid Neoplasm that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 33 participants, roughly in line with the 36-participant average among 9 other Adult Solid Neoplasm trials with a reported enrollment target. The trial reports 1 study location across 1 state.

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The verdict

NCT00217373, a Phase 1 study of Adult Solid Neoplasm, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 1
Development phase
33 participants
Enrollment target
1
Study location

Study 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.

Conditions Studied

Adult Solid Neoplasm

Interventions

  • BIOLOGICAL Sargramostim
  • BIOLOGICAL Recombinant Interferon Alfa-2b
  • BIOLOGICAL Recombinant Fowlpox-CEA(6D)/TRICOM Vaccine
  • BIOLOGICAL Recombinant Vaccinia-CEA(6D)-TRICOM Vaccine

Study Locations (1)

Ohio

  • Ohio State University Comprehensive Cancer Center - Columbus

Trial Details

FieldValue
Enrollment Target 33 participants
Start Date 2005-06
Est. Completion 2015-03
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

3,257 total trials

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What the Registry Record Tells You About NCT00217373

The ClinicalTrials.gov registry entry for NCT00217373 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 36-participant average among 9 other Adult Solid Neoplasm trials with a reported enrollment target. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Adult Solid Neoplasm appearing as the primary indexed condition, and to 4 interventions - of which Sargramostim is the first listed.

NCT00217373 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.

Frequently Asked Questions

What is clinical trial NCT00217373 about?

NCT00217373 is a clinical study titled "Vaccine Therapy, GM-CSF, and Interferon Alfa-2b in Treating Patients With Locally Advanced or Metastatic Cancer That Expresses Carcinoembryonic Antigen (CEA)". 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...

What is the current status of trial NCT00217373?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2005-06. Estimated completion is 2015-03.

What conditions does trial NCT00217373 study?

This clinical trial studies the following conditions: Adult Solid Neoplasm.

What interventions are being tested in trial NCT00217373?

The interventions under investigation include: Sargramostim (BIOLOGICAL), Recombinant Interferon Alfa-2b (BIOLOGICAL), Recombinant Fowlpox-CEA(6D)/TRICOM Vaccine (BIOLOGICAL), Recombinant Vaccinia-CEA(6D)-TRICOM Vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT00217373?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00217373 being conducted?

This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.