A Phase 1-2 Study for Stage IV Breast and HER2/Neu Positive Cancers to Evaluate the Safety and Efficacy of a Vaccine Using Whole Cells From the SVBR- 1-GM Cell Line Genetically Engineered To Produce Granulocyte- Macrophage Colony Stimulating Factor

Wiseman Research Initiatives LLC2 sites in 1 country24 target enrollmentNovember 2004

ConditionsBreast Cancer Unspecified Adult Solid Tumor, Protocol Specific

Drugscyclophosphamide

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: Wiseman Research Initiatives LLC
Enrollment: 24
Locations: 2
Primary Endpoint: Survival
Status: Terminated
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

RATIONALE: Vaccines made from gene-modified tumor cells may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of tumor cells. Combining vaccine therapy with cyclophosphamide and interferon alfa may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combining vaccine therapy with interferon alfa and cyclophosphamide in treating patients who have stage IV breast cancer.

Detailed Description

OBJECTIVES: * Determine the safety, tolerability, and feasibility of vaccine therapy comprising an allogeneic (non-self) tumor cell line transfected with the sargramostim (GM-CSF) gene combined with low-dose interferon alfa and low-dose cyclophosphamide in patients with stage IV breast cancer or other solid tumors. * Determine the clinical response, time to progression, and survival of patients treated with this regimen. * Correlate clinical response with immunological response in patients treated with this regimen. OUTLINE: Patients receive low-dose cyclophosphamide IV once 2-3 days before each tumor vaccine. Patients then receive tumor vaccine comprising HER2/neu-positive allogeneic (non-self) breast cancer cells transfected with the sargramostim (GM-CSF) gene intradermally (ID) on day 1. Patients also receive low-dose interferon alfa ID approximately 48 and 96 hours after each tumor vaccine. Treatment repeats every 2 weeks for 3 vaccinations and then monthly for 3 vaccinations in the absence of disease progression or unacceptable toxicity. Patients are followed at 2 weeks and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 9-24 patients will be accrued for this study.

Registry

clinicaltrials.gov

Start Date

November 2004

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional

Sex

All