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

Phase 1

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00079157
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

Brief 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.

Detailed Description

OBJECTIVES:

Primary

* Determine the safety of telomerase: 540-548 peptide vaccine emulsified in Montanide ISA-51 and sargramostim (GM-CSF) in patients with HLA-A2-expressing stage IV breast cancer.

Secondary

* Compare the generation of human telomerase reverse transcriptase (hTERT) peptide-specific vs cytomegalovirus peptide-specific cytotoxic T-lymphocyte (CTL) immunity in patients treated with this regimen.

* Correlate the dose level of this regimen with the generation of hTERT-specific CTL immunity and the development of hTERT-specific autoimmunity in these patients.

* Determine the tumor response in patients treated with this regimen.

OUTLINE: This is a dose-escalation study of the telomerase: 540-548 peptide and CMV 495 peptide portions of the vaccine.

Patients receive telomerase: 540-548 peptide and CMV 495 peptide (as an immunological control) vaccine emulsified in Montanide ISA-51 subcutaneously (SC) followed by sargramostim (GM-CSF) SC on day 1 of weeks 1, 3, 5, 7, 11, 15, 19, and 27 (for a total of 8 vaccinations). Treatment continues in the absence of disease progression or unacceptable toxicity.

Cohorts of 5-8 patients receive escalating doses of telomerase: 540-548 peptide and CMV 495 peptide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 5 or 2 of 8 patients experience dose-limiting toxicity. A total of 12 patients receive treatment at the MTD.

Patients are followed within 30 days and then at 6 and 12 months.

PROJECTED ACCRUAL: A total of 5-28 patients will be accrued for this study.

Study Timeline

• Study Start: 2004-02
• Study First Submitted: 2004-03-08
• Study First Submitted QC: 2004-03-09
• Study First Posted: 2004-03-10
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-03
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Abramson Cancer Center of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States