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α-lactalbumin vaccine for Breast Cancer

Phase < 1
Recruiting
Led By George T Budd, MD
Research Sponsored by George T. Budd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate major organ function, defined as: WBC ≥ 3,000/mcl, hemoglobin ≥ 10.0 gm/dL, platelets >100,000/mcL, total bilirubin within normal limits, ALT/AST <3 x upper limits of normal (ULN), serum creatinine ≤ 1.5 x ULN.
Histologically proven invasive breast cancer.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 84
Awards & highlights

Study Summary

This trial is testing a new vaccine to treat triple negative breast cancer, which is a difficult to treat form of the disease. They are testing to see if it is safe and what the most effective dose is.

Who is the study for?
This trial is for adults with non-metastatic triple-negative breast cancer who have completed initial treatment within the last 36 months, or those at high risk of developing such cancer. Participants must not be pregnant, breastfeeding, or using hormonal contraception and should have no recent history of chemotherapy or radiation therapy. They need normal organ function and cannot be on immunosuppressants.Check my eligibility
What is being tested?
The study tests the safety and optimal dose of an alpha-lactalbumin vaccine in treating patients free from metastatic triple-negative breast cancer but at risk for recurrence, as well as preventing it in high-risk individuals. It also includes participants receiving adjuvant pembrolizumab after initial treatment.See study design
What are the potential side effects?
Potential side effects are not detailed in the provided information; however, common reactions to vaccines may include soreness at injection site, fever, fatigue, headache and allergic reactions. Specific side effects will depend on individual patient responses to the alpha-lactalbumin vaccine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My blood tests show my organs are functioning well.
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My breast cancer diagnosis was confirmed through a biopsy.
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My scans show no signs of cancer coming back.
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My breast cancer is considered high risk based on its stage or because cancer remains after chemotherapy.
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My breast cancer is at an advanced stage but not the most severe, or I still have cancer after chemotherapy.
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My breast cancer is triple-negative according to the latest guidelines.
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I am 18 years old or older.
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My blood and organ tests are within normal ranges.
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My breast cancer is triple-negative.
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I am fully active or can carry out light work.
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I am 18 years old or older.
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I am older than 18 years.
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I carry a harmful BRCA1 or PALB2 mutation, increasing my risk for triple-negative breast cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 84
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 84 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pembrolizumab Cohort of α-lactalbumin vaccine
Preventative Cohort MTD of α-lactalbumin vaccine
Treatment Cohort MTD of α-lactalbumin vaccine
Secondary outcome measures
Pembrolizuman Cohort Lowest Immunologic Dose (LID) of α-lactalbumin vaccine
Preventative Cohort Lowest Immunologic Dose (LID) of α-lactalbumin vaccine
Treatment Cohort Lowest Immunologic Dose (LID) of α-lactalbumin vaccine

Trial Design

3Treatment groups
Experimental Treatment
Group I: Treatment α-lactalbumin and zymosanExperimental Treatment2 Interventions
Participants diagnosed with triple negative breast cancer (TNBC) will be treated with successively higher doses of α-lactalbumin and zymosan in a traditional 3 + 3 phase I trial design. Treatment will involve a course of 3 vaccinations given every 2 weeks. Participants will be enrolled sequentially into 1 of 5 different dose levels each comprised of cohorts of 1-6 participants until the MTD has been identified (intra-patient dose escalation not permitted), after which the MTD will be expanded to 6 participants. Successively lower doses will be expanded to 6 participants until the lowest DL associated with immune response has been expanded. Dose Level (DL) 1: 10 microgram (mcg) a-lactalbumin + 10 mcg Zymosan DL2: 100 mcg a-lactalbumin + 10 mcg Zyomsan DL3: 500 mcg a-lactalbumin + 10 mcg Zymosan DL1b: 50 mcg a-lactalbumin + 10 mcg Zymosan DL1c: 50 mcg a-lactalbumin + 50 mcg Zymosan DL1d: 50 mcg a-lactalbumin + 30 mcg Zymosan (DL1d will only be utilized if 1c is too toxic)
Group II: Standard of Care with a-lactalbumin and zymosanExperimental Treatment2 Interventions
Participants undergoing chemo-immunotherapy for operable triple-negative breast cancer will be treated with α-lactalbumin concurrently with standard of care adjuvant pembrolizumab after having completed all pre- and postoperative chemotherapy and radiation therapy, with the exception of Xeloda/capecitabine at provider discretion. Treatment will involve 3 vaccinations given every 2 weeks. Participants enrolled in the Pembrolizumab cohort will be enrolled at the proper Optimal Immunologic Dose as defined by the TNBC and preventative cohorts and based on information available at the time of study entry. Dose Level (DL) 1: 10 microgram (mcg) a-lactalbumin + 10 mcg Zymosan DL2: 100 mcg a-lactalbumin + 10 mcg Zyomsan DL3: 500 mcg a-lactalbumin + 10 mcg Zymosan DL1b: 50 mcg a-lactalbumin + 10 mcg Zymosan DL1c: 50 mcg a-lactalbumin + 50 mcg Zymosan DL1d: 50 mcg a-lactalbumin + 30 mcg Zymosan (DL1d will only be utilized if 1c is deemed too toxic)
Group III: Preventitive a-lactalbumin and zymosanExperimental Treatment2 Interventions
Participants with a genetic risk for developing TNBC who plan to undergo prophylactic mastectomy will be treated with α-lactalbumin and zymosan at doses based on the TNBC cohort. Treatment will involve a course of 3 vaccinations given every 2 weeks. Participants enrolled in the prevention cohort we will be enrolled at the dose level being used in the TNBC cohort if no DLTs above Grade 1 have been observed. If the TNBC cohort proceeds to the next dose level before another prevention cohort patient is enrolled, the next prevention patient will be enrolled on the next dose level along with the TNBC cohort. Dose Level (DL) 1: 10 microgram (mcg) a-lactalbumin + 10 mcg Zymosan DL2: 100 mcg a-lactalbumin + 10 mcg Zyomsan DL3: 500 mcg a-lactalbumin + 10 mcg Zymosan DL1b: 50 mcg a-lactalbumin + 10 mcg Zymosan DL1c: 50 mcg a-lactalbumin + 50 mcg Zymosan DL1d: 50 mcg a-lactalbumin + 30 mcg Zymosan (DL1d will only be utilized if 1c is deemed too toxic)

Find a Location

Who is running the clinical trial?

Anixa Biosciences, Inc.UNKNOWN
1 Previous Clinical Trials
48 Total Patients Enrolled
George T. BuddLead Sponsor
United States Department of DefenseFED
865 Previous Clinical Trials
327,654 Total Patients Enrolled
38 Trials studying Breast Cancer
103,466 Patients Enrolled for Breast Cancer

Frequently Asked Questions

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

Are there any slots open for participation in this research endeavor?

"Affirmative. Clinicaltrials.gov displays that this trial is still recruiting patients, beginning on October 1st 2021 and last updated June 30th 2022. This medical study requires the recruitment of 30 participants from a single site."

Answered by AI

How many people have enrolled in the research so far?

"Affirmative. Documents available on clinicaltrials.gov demonstrate that this clinical trial is actively searching for participants to enrol in the study, which was first posted on October 1st of 2021 and last updated June 30th 2022. The goal is to recruit up to 30 people from a single site."

Answered by AI

Who else is applying?

What state do they live in?
Wisconsin
What site did they apply to?
Cleveland Clinic, Case Comprehensive Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Most responsive sites:
  1. Cleveland Clinic, Case Comprehensive Cancer Center: < 48 hours
Average response time
  • < 2 Days
Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
Adjuvant Therapy With an Alpha-lactalbumin Vaccine in Triple-Negative Breast Cancer
George T. Budd 2021. "Adjuvant Therapy With an Alpha-lactalbumin Vaccine in Triple-Negative Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04674306.
~0 spots leftby May 2024
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