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
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
Adjuvant used in vaccine preparation
DL1-3: 10 mcg
DL4: 30 mcg
DL5: 60 mcg
- MTD of α-lactalbumin vaccine [ Time Frame: Day 84 ]MTD of an α-lactalbumin vaccine in participants with operable triple-negative breast cancer
- 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
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
|Contact: George T Budd, MD||1-866-223-8100||TaussigResearch@ccf.org|
|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|
|Principal Investigator:||George T Budd, MD||Cleveland Clinic, Case Comprehensive Cancer Center|