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NCT00028496 · ClinicalTrials.gov registry record · Phase 1

Vaccine Therapy With or Without Sargramostim in Treating Patients With Advanced or Metastatic Cancer

A Phase 1 study of Male Breast Cancer and Adenocarcinoma of the Rectum, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 1
Development phase
48
Enrollment target
1
Study location

NCT00028496 is a Phase 1 study of Male Breast Cancer and Adenocarcinoma of the Rectum that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 48 participants, above the 33-participant average among 14 other Male Breast Cancer trials with a reported enrollment target (45% higher). The trial reports 1 study location across 1 state.

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The verdict

NCT00028496, a Phase 1 study of Male Breast Cancer and Adenocarcinoma of the Rectum, has completed, sponsored by National Cancer Institute (NCI).

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

Study 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

Conditions Studied

Male Breast Cancer Adenocarcinoma of the Rectum Adenocarcinoma of the Pancreas Adenocarcinoma of the Colon Advanced Adult Primary Liver Cancer Adult Primary Hepatocellular Carcinoma Diffuse Adenocarcinoma of the Stomach Intestinal Adenocarcinoma of the Stomach Cholangiocarcinoma of the Gallbladder Adenocarcinoma of the Gallbladder

Interventions

  • BIOLOGICAL sargramostim
  • BIOLOGICAL recombinant fowlpox GM-CSF vaccine adjuvant
  • BIOLOGICAL recombinant fowlpox-CEA(6D)/TRICOM vaccine

Study Locations (1)

Pennsylvania

  • Fox Chase Cancer Center - Philadelphia

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2001-11
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

3,257 total trials

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What the Registry Record Tells You About NCT00028496

The ClinicalTrials.gov registry entry for NCT00028496 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 33-participant average among 14 other Male Breast Cancer trials with a reported enrollment target (45% higher). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 10 conditions, with Male Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which sargramostim is the first listed.

NCT00028496 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT00028496 about?

NCT00028496 is a clinical study titled "Vaccine Therapy With or Without Sargramostim in Treating Patients With Advanced or Metastatic Cancer". 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 im...

What is the current status of trial NCT00028496?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2001-11.

What conditions does trial NCT00028496 study?

This clinical trial studies the following conditions: Male Breast Cancer, Adenocarcinoma of the Rectum, Adenocarcinoma of the Pancreas, Adenocarcinoma of the Colon, Advanced Adult Primary Liver Cancer.

What interventions are being tested in trial NCT00028496?

The interventions under investigation include: sargramostim (BIOLOGICAL), recombinant fowlpox GM-CSF vaccine adjuvant (BIOLOGICAL), recombinant fowlpox-CEA(6D)/TRICOM vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT00028496?

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

Where is trial NCT00028496 being conducted?

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

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.