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COMPLETED Phase 1

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

NCT00028496 · View on ClinicalTrials.gov ↗

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

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)

2,390 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00028496

The ClinicalTrials.gov registry entry for NCT00028496 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00028496 reports 1 study location spanning 1 distinct geographic area — top geographies include Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00028496?

This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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