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Vaccine Therapy in Treating Patients With Metastatic Breast Cancer

2014-08-27 03:54:47 | BioPortfolio

Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with metastatic breast cancer.

Description

OBJECTIVES:

Primary

- Determine the toxicity of vaccination comprising recombinant vaccinia-MUC-1 and recombinant vaccinia-TRICOM vaccine in patients with metastatic breast cancer.

- Determine the maximum tolerated dose of this regimen in these patients.

- Determine the toxicity of this regimen when administered with sargramostim (GM-CSF) in these patients.

Secondary

- Determine the host immune reactivity in patients treated with this regimen with or without GM-CSF.

- Determine the antitumor activity in patients treated with this regimen with or without GM-CSF.

OUTLINE: This is an open-label, dose-escalation study.

Patients receive vaccination comprising recombinant vaccinia-MUC-1 and recombinant vaccinia-TRICOM vaccine intradermally on days 1 and 29 (for a total of 2 doses) in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of recombinant vaccinia-MUC-1 and recombinant vaccinia-TRICOM vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional 10 patients (including 5 HLA-A2-positive patients) receive vaccination as above at the MTD and sargramostim (GM-CSF) subcutaneously on days 1-4 and 29-32.

Patients are followed at 4 weeks, monthly until disease progression, and then annually for up to 15 years.

PROJECTED ACCRUAL: A total of 11-22 patients will be accrued for this study within 18-24 months.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Conditions

Breast Cancer

Intervention

recombinant vaccinia-MUC-1 vaccine, recombinant vaccinia-TRICOM vaccine, sargramostim

Location

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston
Massachusetts
United States
02115

Status

Completed

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:54:47-0400

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