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

Recruiting at 11 trial locations

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Academic and Community Cancer Research United

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Approximately 2 years

280 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a combination of a special vaccine, an immune booster, and a chemotherapy drug to prevent the return of triple negative breast cancer. It aims to help the immune system fight off cancer cells and use chemotherapy to kill any remaining ones.

Research Team

Kathryn J Ruddy

Principal Investigator

Academic and Community Cancer Research United

Eligibility Criteria

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.

Inclusion Criteria

My breast cancer was surgically removed, is not spread, and tests negative for ER, PR, and HER2.

I am female.

I finished my last breast cancer treatment between 3 and 18 months ago.

Exclusion Criteria

I am currently breastfeeding.

You have had a bad reaction to GM-CSF before.

I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cyclophosphamide and either the multi-epitope folate receptor alpha peptide vaccine with sargramostim or a placebo vaccine with sargramostim. Treatment repeats every 28 days for cycles 2-7 and every 6 months for cycles 8-14.

Approximately 2 years

Follow-up

Participants are monitored for disease-free survival and adverse events every 6 months for 3 years after completion of study treatment.

3 years

Treatment Details

Interventions

• Cyclophosphamide
• Multi-epitope Folate Receptor Alpha Peptide Vaccine
• Sargramostim

Trial Overview 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.

Participant Groups

Group I: Arm I (FRalpha peptide vaccine, sargramostim) Experimental Treatment 4 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 Group 4 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.

Cyclophosphamide is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Cytoxan for:

• Breast cancer
• Ovarian cancer
• Multiple myeloma
• Leukemia
• Lymphoma
• Rheumatoid arthritis

Approved in European Union as Endoxan for:

• Breast cancer
• Ovarian cancer
• Multiple myeloma
• Leukemia
• Lymphoma
• Rheumatoid arthritis

Approved in Canada as Neosar for:

• Breast cancer
• Ovarian cancer
• Multiple myeloma
• Leukemia
• Lymphoma
• Rheumatoid arthritis

Approved in Japan as Endoxan for:

• Breast cancer
• Ovarian cancer
• Multiple myeloma
• Leukemia
• Lymphoma

Who Is Running the Clinical Trial?

Academic and Community Cancer Research United

Lead Sponsor

Trials

54

Recruited

4,900+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+