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NCT01042535 · ClinicalTrials.gov registry record · Phase 1

Vaccine Therapy and 1-MT in Treating Patients With Metastatic Breast Cancer

A Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

Completed
Registry status
Phase 1
Development phase
44
Enrollment target

NCT01042535 is a Phase 1 study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 44 participants.

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The verdict

NCT01042535, a Phase 1 study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

COMPLETED
Registry status
Phase 1
Development phase
44 participants
Enrollment target

Study Summary

This randomized phase I/II trial studies the side effects and best dose of vaccine therapy and to see how well it works when given together with 1-methyl-D-tryptophan (1-MT) in treating patients with metastatic breast cancer. Vaccines made from a person's tumor cells and white blood cells may help the body build an effective immune response to kill tumor cells.

Interventions

  • OTHER Laboratory biomarker analysis
  • DRUG 1-methyl-d-tryptophan
  • BIOLOGICAL adenovirus-p53 transduced dendritic cell (DC) vaccine

Trial Details

FieldValue
Enrollment Target 44 participants
Start Date 2009-12-28
Est. Completion 2018-02-27
Phase Phase 1

What the Registry Record Tells You About NCT01042535

The ClinicalTrials.gov registry entry for NCT01042535 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is H. Lee Moffitt Cancer Center and Research Institute, which has 502 total studies on file at ClinicalTrials.gov.

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

NCT01042535 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01042535 about?

NCT01042535 is a clinical study titled "Vaccine Therapy and 1-MT in Treating Patients With Metastatic Breast Cancer". This randomized phase I/II trial studies the side effects and best dose of vaccine therapy and to see how well it works when given together with 1-methyl-D-tryptophan (1-MT) in treating patients with metastatic breast cancer. Vaccines made from a person's tumor cells and white blood cells may help t...

What is the current status of trial NCT01042535?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2009-12-28. Estimated completion is 2018-02-27.

What interventions are being tested in trial NCT01042535?

The interventions under investigation include: Laboratory biomarker analysis (OTHER), 1-methyl-d-tryptophan (DRUG), adenovirus-p53 transduced dendritic cell (DC) vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT01042535?

This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.

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.