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NCT00079157 · ClinicalTrials.gov registry record · Phase 1

Vaccine Plus Montanide ISA-51 and Sargramostim in Treating Patients With Stage IV Breast Cancer

A Phase 1 study, sponsored by Abramson Cancer Center at Penn Medicine.

Completed
Registry status
Phase 1
Development phase
28
Enrollment target

NCT00079157: Completed Phase 1 study, sponsored by Abramson Cancer Center at Penn Medicine.

NCT00079157 is a Phase 1 study that has completed, run by Abramson Cancer Center at Penn Medicine. The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00079157, a Phase 1 study, has completed, sponsored by Abramson Cancer Center at Penn Medicine.

COMPLETED
Registry status
Phase 1
Development phase
28 participants
Enrollment target

Study Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Giving a vaccine with Montanide ISA-51 and sargramostim may cause a stronger immune response and kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy when given together with Montanide ISA-51 and sargramostim in treating patients with stage IV breast cancer.

Interventions

  • BIOLOGICAL sargramostim
  • BIOLOGICAL incomplete Freund's adjuvant
  • BIOLOGICAL telomerase: 540-548 peptide vaccine

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2004-02
Est. Completion 2007-12
Phase Phase 1

What the finished NCT00079157 record still lists

NCT00079157 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).

The record links to 0 conditions, and to 3 interventions - of which sargramostim is the first listed.

NCT00079157 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00079157 about?

NCT00079157 is a clinical study titled "Vaccine Plus Montanide ISA-51 and Sargramostim in Treating Patients With Stage IV Breast Cancer". RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Giving a vaccine with Montanide ISA-51 and sargramostim may cause a stronger immune response and kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy when ...

What is the current status of trial NCT00079157?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2004-02. Estimated completion is 2007-12.

What interventions are being tested in trial NCT00079157?

The interventions under investigation include: sargramostim (BIOLOGICAL), incomplete Freund's adjuvant (BIOLOGICAL), telomerase: 540-548 peptide vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT00079157?

This trial is sponsored by Abramson Cancer Center at Penn Medicine, which has 402 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00079157's enrollment target sits among peer trials

28 1447th of 2000 higher than 538 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00079157, the US trial registry maintained by the National Library of Medicine. NCT00079157 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.