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Trial record 1 of 2 for:    vaccine, cleveland clinic | breast cancer | cleveland, Ohio, U.S.
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Adjuvant Therapy With an Alpha-lactalbumin Vaccine in Triple-Negative Breast Cancer

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ClinicalTrials.gov Identifier: NCT04674306
Recruitment Status : Recruiting
First Posted : December 19, 2020
Last Update Posted : July 5, 2022
United States Department of Defense
Information provided by (Responsible Party):
George T. Budd, Case Comprehensive Cancer Center

Brief Summary:
The purpose of this study is to determine the safety as well as the most effective dose of the alpha-lactalbumin vaccine (aLA breast cancer vaccine) to treat patients with non-metastatic triple negative breast cancer

Condition or disease Intervention/treatment Phase
Pathologic Stage IIA-IIIC Triple-Negative Breast Cancer TNBC - Triple-Negative Breast Cancer Residual Disease Biological: α-lactalbumin vaccine Biological: Zymosan Early Phase 1

Detailed Description:

This is an open-label, phase I dose-escalation trial in which successive cohorts of participants with high-risk triple-negative breast cancer will be treated with successively higher doses of α-lactalbumin and zymosan

This aLA breast cancer vaccine is an investigational (experimental) drug that the study team believes will work by stimulating the immune system to fight the participant's cancer, in a way similar to the way the immune system fights off an infection after a vaccination for that infection. α-lactalbumin Vaccine is experimental because it is not approved by the Food and Drug Administration (FDA).

A traditional "3+3" Phase I trial design will be employed to determined the Maximum Tolerated Dose (MTD). After identification of the MTD, if at least 1 participant has an immunologic response (correlative measurement), successively lower dose levels will be expanded to a total of 6 participants and immunologic response assessed. Enrollment will stop if a dose level is reached for which no responses are observed. Dose-Limiting toxicities (DLTs) in 2 or more of 6 participants, the next lower dose will be considered the new MTD.

Objectives are to determine MTD, DLT incidence, and Lowest Immunologic Dose (LID).

Toxicity will be assessed every 2 weeks until day 56 and at day 84 or at off-study. Participants will be offered participation in long-term follow-up involving contact or in-person follow-up for late toxicity and survival every 3 months for 2 years, every 6 months for an additional 3 years, and then annually for 10 years.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Trial of Adjuvant Therapy With an Alpha-lactalbumin Vaccine in Patients With Non-Metastatic Triple-Negative Breast Cancer at High Risk of Recurrence
Actual Study Start Date : October 1, 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: α-lactalbumin and zymosan

Participants 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 Zymosan

DL3: 500 mcg a-lactalbumin + 10 mcg Zymosan

DL4: 500 mcg a-lactalbumin + 30 mcg Zymosan

DL5: 500 mcg a-lactalbumin + 60 mcg Zymosan

Biological: α-lactalbumin vaccine

α-lactalbumin vaccine will be administered subcutaneously in rotating sites (vaccine will not be administered in the arms of any participant, due to likelihood of prior bilateral mastectomy).

DL1: 10 mcg

DL2: 100 mcg

DL3-5: 500 mcg

Other Name: α-lactalbumin protein

Biological: Zymosan

Adjuvant used in vaccine preparation

DL1-3: 10 mcg

DL4: 30 mcg

DL5: 60 mcg

Primary Outcome Measures :
  1. MTD of α-lactalbumin vaccine [ Time Frame: Day 84 ]
    MTD of an α-lactalbumin vaccine in participants with operable triple-negative breast cancer

Secondary Outcome Measures :
  1. Lowest Immunologic Dose (LID) of α-lactalbumin vaccine [ Time Frame: Day 84 ]
    LID of α-lactalbumin vaccine in participants with operable triple-negative breast cancer, based on ELISPOT assays to assess the ability to induce a pro-inflammatory T cell response consistent with tumor protection. This assessment will be determined using the ELISPOT assay to determine peripheral blood frequencies of T cells that produce interferon-gamma (IFNγ; type-1) and IL-17 (type-17) in response to recombinant human α-lactalbumin

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically proven invasive breast cancer.
  • Primary tumor must be ER-negative (ER in <1% of cells), PR-negative (PR in <1% of cells), and HER2-negative (0-1+ by IHC or FISH ratio<2.0 with signal number <6/cell), or consistent with contemporary NCCN guidelines (https://www.nccn.org/).
  • Patients must be high risk, defined as either:
  • Pathologic stage IIA, IIB, IIIA, IIIB, or IIIC by AJCC 8, or
  • Residual invasive cancer in breast or regional nodes following preoperative chemotherapy.
  • Patients must have no convincing evidence of recurrent disease based on one of the following:
  • bone scan and imaging scans of the chest/abdomen/pelvis or
  • FDG PET scan.
  • >1 months since last active therapy (chemotherapy, radiation therapy, or surgery) and <36 months since the initiation of treatment for the current cancer, based on the period of highest risk for patients with Stages I-III triplenegative breast cancer [33, 34].
  • Treatment prior to enrollment must be consistent with contemporary NCCN guidelines, found at: https://www.nccn.org/.
  • Age >18 years.
  • ECOG Performance Status 0-1.
  • 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.

  • Serum prolactin level must be < upper limits of normal (ULN).
  • Subjects must have the ability to understand and the willingness to sign and provide a written informed consent document.
  • Subjects must have archival tissue available for potential correlative studies (e.g., assays for α-lactalbumin expression or tumor infiltrating lymphocytes), but tumors will not be required to exhibit overexpression of α-lactalbumin for enrollment.
  • Subject agrees not to use alternative therapies from the time of informed consent through 30 days following the last vaccine injection (see section

Exclusion Criteria:

  • Receipt of cytotoxic chemotherapy within 4 weeks of study entry.
  • Radiation therapy within 4 weeks of study entry.
  • Failure to recover from the toxicity of the previous therapy to CTCAE Grade 0-1, except for alopecia and grade 2 neuropathy.
  • Need for systemic corticosteroid use (except as physiologic replacement, defined as prednisone 10 mg/day or equivalent).
  • Need for immunosuppression (e.g., for a history of organ transplantation).
  • Known HIV infection.
  • Active or planned lactation or pregnancy.
  • Patients taking or planning to take oral contraceptives will be excluded, as there is some evidence that such agents can induce lactational foci. This includes patients using hormone containing IUD's.
  • Refusal to use effective non-hormonal contraception. Acceptable contraception methods include but may not be limited to barrier contraception (diaphragm or condom), non-hormonal intrauterine device, vasectomy of male partner.
  • Subjects receiving any other investigational agents within the last 4 weeks.
  • Subjects with any known recurrence or metastasis.
  • Subjects with a history of another active invasive malignancy within 5 years of study entry.
  • History of allergic reactions to α-lactalbumin, human milk (excluding lactose intolerance), zymosan, or other agents used in this study.
  • Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Subjects with known hyperprolactinemia.
  • Subjects being treated with drugs known to cause hyperprolactinemia (see appendix 2).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04674306

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Contact: George T Budd, MD 1-866-223-8100 TaussigResearch@ccf.org

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United States, Ohio
Cleveland Clinic, Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44915
Contact: George T Budd, MD    866-223-8100    TaussigResearch@ccf.org   
Principal Investigator: George T Budd, MD         
Sponsors and Collaborators
George T. Budd
United States Department of Defense
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Principal Investigator: George T Budd, MD Cleveland Clinic, Case Comprehensive Cancer Center
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Responsible Party: George T. Budd, Principal Investigator, Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT04674306    
Other Study ID Numbers: CASE6119
W81XWH-17-1-0593 ( Other Grant/Funding Number: United States Department of Defense )
W81XWH-17-1-0592 ( Other Grant/Funding Number: United States Department of Defense )
First Posted: December 19, 2020    Key Record Dates
Last Update Posted: July 5, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Yes, the data will be shared with the FDA, the Department of Defense (DOD), and Anixa Biosciences who has negotiated rights to the drug, and any pharmaceutical partner who may wish to negotiate rights to the drug. All below may be shared, with patient data anonymized
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: The data will become available during the course of the trial and indefinitely thereafter.
Access Criteria: The data will be available to the FDA and DOD. Otherwise, a confidentiality agreement will need to be in place.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases