Clinical Trials /

Adjuvant Therapy With an Alpha-lactalbumin Vaccine in Triple-Negative Breast Cancer

NCT04674306

Description:

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

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Early Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Adjuvant Therapy With an Alpha-lactalbumin Vaccine in Triple-Negative Breast Cancer
  • 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

Clinical Trial IDs

  • ORG STUDY ID: CASE6119
  • NCT ID: NCT04674306

Conditions

  • Stage IIA Triple Negative Breast Cancer
  • Triple Negative Breast Cancer

Interventions

DrugSynonymsArms
α-lactalbumin vaccineα-lactalbumin proteinα-lactalbumin and zymosan
Zymosanα-lactalbumin and zymosan

Purpose

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

Detailed Description

      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).
    

Trial Arms

NameTypeDescriptionInterventions
α-lactalbumin and zymosanExperimentalParticipants will be treated with successively higher doses of α-lactalbumin and zymosan. Treatment will involve a course of 3 vaccinations given 4 weeks apart. 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, after which the MTD will be expanded to 6 participants, and subsequently successively lower doses will be expanded to 6 participants until the lowest DL associated with immune response has been expanded. Dose Level (DL) 1: 1 (Microgram) mcg a-lactalbumin + 1 mcg Zymosan DL 2: 10 mcg a-lactalbumin + 10 mcg Zymosan DL 3: 100 mcg a-lactalbumin + 00 mcg Zymosan DL5: 500 mcg a-lactalbumin + 500 mcg Zymosan DL6: 1000 mcg a-lactalbumin + 1000 mcg Zymosan
  • α-lactalbumin vaccine
  • Zymosan

Eligibility Criteria

        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).
             4.1.3 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.

                    -  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
                       triple-negative breast cancer

          -  Treatment prior to enrollment must be consistent with contemporary NCCN guidelines,
             found at: https://www.nccn.org/

          -  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);

          -  Participants must have the ability to understand and the willingness to sign and
             provide a written informed consent document;

          -  Participants 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.

          -  Participants agrees not to use alternative therapies from the time of informed consent
             through 30 days following the last vaccine injection

        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

          -  Participants receiving any other investigational agents within the last 4 weeks.

          -  Participants with any known recurrence or metastasis

          -  Participants 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

          -  Participants 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

          -  Participants with known hyperprolactinemia

          -  Participants being treated with drugs known to cause hyperprolactinemia

          -  Known allergy to penicillin
      
Maximum Eligible Age:N/A
Minimum Eligible Age:19 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Maximum Tolerated Dose (MTD) of an α-lactalbumin vaccine in non-metastatic triple-negative breast cancer participants
Time Frame:4 weeks after administration of final vaccination
Safety Issue:
Description:MTD of an α-lactalbumin vaccine in participants with non-metastatic triple-negative breast cancer

Secondary Outcome Measures

Measure:Lowest Immunologic Dose (LID) of α-lactalbumin vaccine in participants with operable triple-negativebreast cancer
Time Frame:4 weeks after administration of final vaccination
Safety Issue:
Description:LID of α-lactalbumin vaccine in participants with operable triple-negativebreast 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

Details

Phase:Early Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:George T. Budd

Last Updated

December 19, 2020