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Chemotherapy

Cancer Vaccine + GM-CSF and Cyclophosphamide for Triple Negative Breast Cancer

Phase 2

Waitlist Available

Led By Kathryn J Ruddy

Research Sponsored by Academic and Community Cancer Research United

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >= 18 years

Female

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion (average of 5 years)

Awards & highlights

Study Summary

This trial is testing a vaccine made from a person's white blood cells mixed with tumor proteins, given with sargramostim (GM-CSF) and cyclophosphamide, to see if it can prevent the recurrence of stage 1-3 triple negative breast cancer.

Who is the study for?

This trial is for women aged 18+ with stage 1-3 triple negative breast cancer who've completed surgery and other treatments within the past 90 to 546 days. They must have a good performance status, adequate organ function, and no evidence of metastatic disease or recurrence. Women must not be pregnant, nursing, immunocompromised on antiretroviral therapy, or have active autoimmune diseases.Check my eligibility

What is being tested?

The study tests if a vaccine made from white blood cells and tumor proteins plus GM-CSF (sargramostim) and cyclophosphamide can prevent cancer recurrence in patients post-surgery. Participants are randomly assigned to receive either this combination treatment or a placebo in an effort to stimulate the immune system against cancer cells.See study design

What are the potential side effects?

Potential side effects include reactions at the injection site from the vaccine, flu-like symptoms due to GM-CSF, and typical chemotherapy-related issues like nausea, hair loss, low blood cell counts leading to increased infection risk from cyclophosphamide.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am female.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion (average of 5 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion (average of 5 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion (average of 5 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Disease-free survival

Secondary outcome measures

FRalpha levels

Incidence of adverse events assessed by Common Terminology Criteria for Adverse Events 4.0

Overall survival

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm I (FRalpha peptide vaccine, sargramostim)Experimental Treatment4 Interventions

Patients receive cyclophosphamide PO 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 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.

Group II: Arm II (placebo, sargramostim)Placebo Group4 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

1995

Completed Phase 3

~3780

Multi-epitope Folate Receptor Alpha Peptide Vaccine

2012

Completed Phase 1

~30

Sargramostim

2008

Completed Phase 4

~710

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Academic and Community Cancer Research UnitedLead Sponsor

53 Previous Clinical Trials

4,856 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,932,873 Total Patients Enrolled

940 Trials studying Breast Cancer

1,543,360 Patients Enrolled for Breast Cancer

Kathryn J RuddyPrincipal InvestigatorAcademic and Community Cancer Research United

1 Previous Clinical Trials

100 Total Patients Enrolled

Media Library

Cyclophosphamide (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03012100 — Phase 2

Breast Cancer Research Study Groups: Arm I (FRalpha peptide vaccine, sargramostim), Arm II (placebo, sargramostim)

Breast Cancer Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT03012100 — Phase 2

Cyclophosphamide (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03012100 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What adverse effects have been reported with administering the Multi-epitope Folate Receptor Alpha Peptide Vaccine?

"Our experts at Power rated the safety of Multi-epitope Folate Receptor Alpha Peptide Vaccine a 2, as data collected from Phase 2 trials demonstrate its relative security yet there is no evidence for efficacy."

Answered by AI

Are there any records of other experiments involving Multi-epitope Folate Receptor Alpha Peptide Vaccine?

"In 1997, Multi-epitope Folate Receptor Alpha Peptide Vaccine was first researched by City of Hope Comprehensive Cancer Center. Since then, 1850 studies have been completed. Presently 865 clinical trials are actively recruiting participants across the USA, with a notable concentration in Boston ma."

Answered by AI

In how many distinct areas is this clinical experiment being managed?

"This medical study has 11 unique sites of operation, including the Massachusetts General Hospital Cancer Center in Boston, Ochsner Medical Center Jefferson in New Orleans, and Mayo Clinic Arizona in Scottsdale. Additional locations are available as well."

Answered by AI

What is the typical purpose for administering Multi-epitope Folate Receptor Alpha Peptide Vaccine?

"The Multi-epitope Folate Receptor Alpha Peptide Vaccine is typically used to treat the proliferation of lung cancer. In some cases, it has been employed as an intervention for lymphoma, Hodgkin's disease, bone marrow transplantation and multiple sclerosis."

Answered by AI

How many participants have joined this research endeavor?

"Unfortunately, this research is currently not accepting applicants. This experiment was first posted in March of 2017 and last updated on September 23rd 2022. Fortunately, there are 4,600 studies investigating breast cancer and 865 experiments exploring the Multi-epitope Folate Receptor Alpha Peptide Vaccine that are actively recruiting patients at present."

Answered by AI

Are recruitment efforts still ongoing for this clinical experiment?

"At the present moment, this clinical trial is not actively recruiting. Initially posted on March 31st 2017 and last updated on September 23rd 2022, people seeking to participate in medical research should consider one of the 4600 trials enrolling patients with breast cancer or 865 studies for Multi-epitope Folate Receptor Alpha Peptide Vaccine which are currently open."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2017. "Multi-epitope Folate Receptor Alpha Peptide Vaccine, GM-CSF, and Cyclophosphamide in Treating Patients With Triple Negative Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03012100.

All > Metastatic Triple Negative Breast Cancer > Louisiana