Trials / Active Not Recruiting

Active Not RecruitingNCT03012100

Multi-epitope Folate Receptor Alpha Peptide Vaccine, GM-CSF, and Cyclophosphamide in Treating Patients With Triple Negative Breast Cancer

Double Blind, Parallel Groups, Controlled, Randomized Phase II Trial to Evaluate Vaccination With Folate Receptor Alpha Peptide Vaccine With GM-CSF as Vaccine Adjuvant Following Oral Cyclophosphamide Versus GM-CSF/Placebo to Prevent Recurrence in Patients With Triple Negative Breast Cancer

Status: Active Not Recruiting
Phase: Phase 2
Study type: Interventional
Enrollment: 280 (actual)

Sponsor: Academic and Community Cancer Research United · Academic / Other
Sex: Female
Age: 18 Years
Healthy volunteers: Not accepted

Summary

This randomized phase II trial studies how well multi-epitope folate receptor alpha peptide vaccine, sargramostim (GM-CSF), and cyclophosphamide work to prevent the recurrence of stage 1-3 triple negative breast cancer. Vaccines made from a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving multi-epitope folate receptor alpha peptide vaccine, sargramostim (GM-CSF), and cyclophosphamide may work well together to prevent cancer recurrence after surgery and other standard treatments for triple negative breast cancer.

Detailed description

PRIMARY OBJECTIVE: I. To show that multi-epitope folate receptor alpha peptide vaccine (folate receptor \[FR\]alpha peptide vaccine) with sargramostim (GM-CSF) adjuvant will prolong the disease-free survival (DFS) compared to GM-CSF adjuvant treatment in patients with triple negative breast cancer. SECONDARY OBJECTIVE: I. To compare the safety and tolerability of metronomic cyclophosphamide followed by FRalpha peptide vaccine with GM-CSF versus GM-CSF alone. CORRELATIVE RESEARCH OBJECTIVES: I. To determine whether high level of antibody and cellular immune response toward the FRalpha measured at baseline is a prognostic factor for vaccine immune response and/or cancer relapse. II. To determine whether the level of tumor expression of FRalpha at baseline is a prognosis factor for vaccine immune response and/or cancer relapse. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive cyclophosphamide orally (PO) twice daily (BID) on days 1-7 and 15-21 of cycle 1 only. Starting cycle 2, patients receive multi-epitope folate receptor alpha peptide vaccine with sargramostim intradermally (ID) on day 1. Treatment repeats every 28 days for cycles 2-7 and every 6 months for cycles 8-14 in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive cyclophosphamide as in Arm I. Starting cycle 2, patients receive placebo vaccine with sargramostim ID on day 1. Treatment repeats every 28 days for cycles 2-7 and every 6 months for cycles 8-14 in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for 3 years.

Conditions

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
BIOLOGICAL	Multi-epitope Folate Receptor Alpha Peptide Vaccine	Given ID
OTHER	Placebo Administration	Given ID
BIOLOGICAL	Sargramostim	Given ID

Timeline

Start date: 2017-03-31
Primary completion: 2022-08-30
Completion: 2026-07-31
First posted: 2017-01-06
Last updated: 2023-01-13

Locations

12 sites across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT03012100. Inclusion in this directory is not an endorsement.