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COMPLETED Phase 2

Vaccine Therapy, Interleukin-2, and Sargramostim in Treating Patients With Advanced Tumors

NCT00003125 · View on ClinicalTrials.gov ↗

Study Summary

RATIONALE: 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. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Combining vaccine therapy, sargramostim, and interleukin-2 may kill more cancer cells. PURPOSE: Randomized phase II trial to study the effectiveness of vaccine therapy, sargramostim, and interleukin-2 in treating patients who have advanced tumors.

Interventions

  • BIOLOGICAL aldesleukin
  • BIOLOGICAL sargramostim
  • BIOLOGICAL ALVAC-CEA vaccine
  • BIOLOGICAL vaccinia-CEA vaccine

Study Locations (2)

District of Columbia

  • Lombardi Cancer Center, Georgetown University — Washington D.C.

Maryland

  • National Naval Medical Center — Bethesda

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 1998-01
Est. Completion 2004-11
Phase Phase 2

Sponsor

Georgetown University

109 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00003125

The ClinicalTrials.gov registry entry for NCT00003125 describes a study currently listed as completed. It is categorized as Phase 2, 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 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Georgetown University, which has 109 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 6 conditions, with Breast Cancer appearing as the primary indexed condition, and to 4 interventions — of which aldesleukin 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: NCT00003125 reports 2 study locations spanning 2 distinct geographic areas — top geographies include District of Columbia, Maryland. 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 NCT00003125 about?

NCT00003125 is a clinical study titled "Vaccine Therapy, Interleukin-2, and Sargramostim in Treating Patients With Advanced Tumors". RATIONALE: 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. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Combining vaccine therapy, sargramostim, and int...

What is the current status of trial NCT00003125?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 1998-01. Estimated completion is 2004-11.

What conditions does trial NCT00003125 study?

This clinical trial studies the following conditions: Breast Cancer, Lung Cancer, Pancreatic Cancer, Gastric Cancer, Esophageal 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 NCT00003125?

The interventions under investigation include: aldesleukin (BIOLOGICAL), sargramostim (BIOLOGICAL), ALVAC-CEA vaccine (BIOLOGICAL), vaccinia-CEA vaccine (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00003125?

This trial is sponsored by Georgetown University, which has 109 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00003125 being conducted?

This trial has 2 study locations across District of Columbia, Maryland. 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