Vaccine Therapy in Treating Patients With Stage III or Stage IV Breast Cancer

Phase 1

Completed

• Conditions: Breast Cancer
• Interventions: Biological: synthetic breast cancer peptides-tetanus toxoid-Montanide ISA-51 vaccine

• Registration Number: NCT00304096
• Lead Sponsor: University of Virginia

Brief Summary

RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Giving booster vaccinations may make a stronger immune response and kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects of vaccine therapy in treating patients with stage III or stage IV breast cancer.

Detailed Description

OBJECTIVES:

Primary

* Determine the safety of a vaccine comprising multiple synthetic breast cancer-associated peptides and a tetanus toxoid helper peptide emulsified in Montanide ISA-51 in patients with stage III or IV adenocarcinoma of the breast.

* Determine, preliminarily, the frequency of immune responses against the 9 class I MHC-restricted peptides in patients treated with the vaccine.

* Determine, preliminarily, the cytotoxic responses of T-cells to allogeneic breast cancer cells and autologous breast cancer cells (when available).

OUTLINE: This is an open-label study.

Patients receive peptide vaccine comprising 9 synthetic breast cancer peptides and tetanus toxoid helper peptide emulsified in Montanide ISA-51 subcutaneously and intradermally once daily on days 1, 8, 15, 36, 57, and 78 in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 1 year.

PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study.

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2006-03-15
• Study First Submitted QC: 2006-03-15
• Study First Posted: 2006-03-17
• Primary Completion: 2007-06
• Study Completion: 2008-04
• Results First Submitted: 2013-01-15
• Status Verified: 2013-02
• Results First Submitted QC: 2013-02-26
• Last Update Submitted: 2013-02-26
• Results First Posted: 2013-04-09
• Last Update Posted: 2013-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stratum 1: Receiving Hormone Therapy	synthetic breast cancer peptides-tetanus toxoid-Montanide ISA-51 vaccine	Patients treated with 9 peptide vaccine who received hormone therapy
Stratum 2: Not receiving hormone therapy	synthetic breast cancer peptides-tetanus toxoid-Montanide ISA-51 vaccine	Patients receiving 9 peptide vaccine who did not receive hormone therapy

Primary Outcome Measures

Name	Time	Method
The Number of Participants Who Experienced Dose-limiting Adverse Events	30 days post administration of last vaccine	Safety of the 9-peptide mixture if fewer than 33% of patients experience a dose-limiting toxicity

Secondary Outcome Measures

Name	Time	Method
The Number of Participants With T-cell Responses Against the Vaccine as Measured by Elispot Assay After 14 Day in Vitro Sensitization	Days 1-78

Trial Locations

Locations (1)

University of Virginia Cancer Center; 🇺🇸 Charlottesville, Virginia, United States