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NCT00971737 · ClinicalTrials.gov registry record · Phase 2

Cyclophosphamide and Vaccine Therapy With or Without Trastuzumab in Treating Patients With Metastatic Breast Cancer

A Phase 2 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

Completed
Registry status
Phase 2
Development phase
63
Enrollment target

NCT00971737 is a Phase 2 study that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 63 participants.

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The verdict

NCT00971737, a Phase 2 study, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

COMPLETED
Registry status
Phase 2
Development phase
63 participants
Enrollment target

Study Summary

RATIONALE: Vaccines made from gene-modified tumor cells may help the body build an effective immune response to kill tumor cells. Biological therapies, such as cyclophosphamide and trastuzumab, may increase the number of immune cells and make the immune response stronger. It is not yet known whether giving cyclophosphamide together with vaccine therapy is more effective with or without trastuzumab in treating patients with metastatic breast cancer. PURPOSE: This randomized phase II trial is studying the side effects of giving cyclophosphamide together with vaccine therapy and to see how well it works compared with giving cyclophosphamide and vaccine therapy together with trastuzumab in treating patients with metastatic breast cancer.

Interventions

  • DRUG cyclophosphamide
  • BIOLOGICAL trastuzumab
  • BIOLOGICAL allogeneic GM-CSF-secreting breast cancer vaccine

Trial Details

FieldValue
Enrollment Target 63 participants
Start Date 2009-07
Est. Completion 2016-03
Phase Phase 2

What the Registry Record Tells You About NCT00971737

The ClinicalTrials.gov registry entry for NCT00971737 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total studies on file at ClinicalTrials.gov.

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

NCT00971737 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00971737 about?

NCT00971737 is a clinical study titled "Cyclophosphamide and Vaccine Therapy With or Without Trastuzumab in Treating Patients With Metastatic Breast Cancer". RATIONALE: Vaccines made from gene-modified tumor cells may help the body build an effective immune response to kill tumor cells. Biological therapies, such as cyclophosphamide and trastuzumab, may increase the number of immune cells and make the immune response stronger. It is not yet known whether...

What is the current status of trial NCT00971737?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 63 participants. The study started on 2009-07. Estimated completion is 2016-03.

What interventions are being tested in trial NCT00971737?

The interventions under investigation include: cyclophosphamide (DRUG), trastuzumab (BIOLOGICAL), allogeneic GM-CSF-secreting breast cancer vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT00971737?

This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.

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

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