NCT00090480

A Phase I/II Study of an Antitumor Vaccination Using Alpha(1,3)Galactosyltransferase Expressing Allogeneic Tumor Cells in Patients With Relapsed or Refractory Breast Cancer

Terminated Phase 1/Phase 2 Last updated 26 May 2020

What this trial tests

Phase 1/Phase 2 trial testing HyperAcute - Breast cancer vaccine in Breast Cancer in 3 participants. Terminated before completion.

Timeline

1 August 2004

Primary endpoint
1 September 2007

1 September 2007

Quick facts

Lead sponsor	NewLink Genetics Corporation
Phase	Phase 1/Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	3
Start date	1 August 2004
Primary completion	1 September 2007
Estimated completion	1 September 2007
Sites	1 location across United States

Drugs / interventions tested

• HyperAcute - Breast cancer vaccine — full drug profile →

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

NewLink Genetics Corporation — full company profile →

Who can join

18 and older, any sex, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• To determine the safety and efficacy of administration of HyperAcute Breast (HAB) cancer cells by injection into women with recurrent or refractory breast carcinoma
  Time frame: 4 months

Sponsor's own description

This 2-phase study will determine the safety of treating patients with breast cancer with the genetically engineered HyperAcute-Breast cancer vaccine. It will establish the proper vaccine dose and will examine side effects and potential benefits of the treatment. The vaccine contains killed breast cancer cells containing a mouse gene that causes the production of a foreign pattern of protein-sugars on the cell surface. It is hoped that the immune response to the foreign substance will stimulate the immune system to attack the patient's own cancer cells that have similar proteins without this sugar pattern, causing the tumor to remain stable or shrink.

Patients 18 years of age or older with breast cancer that has recurred or no longer responds to standard treatment may be eligible for this study. Candidates will be screened with medical history and physical examination, blood tests, urinalysis, chest x-rays and CT scans. MRI, PET, and ultrasound scans may be obtained if needed.

Participants will receive four vaccinations a month apart from each other. The vaccines will be injected under the skin, similar to the way a tuberculosis skin test is given. Phase I of the study will treat successive groups of patients with increasing numbers of the vaccine cells to evaluate side effects of the treatment and determine the optimum dose. Phase II will look for any beneficial effects of the vaccine given at the highest dose found to be safe in Phase I. Weekly blood samples will be drawn during the 4 months of vaccine treatment. In addition, patient follow-up visits will be scheduled every 2 months for the first year after vaccination and then every 3 months for the next 2 years for the following tests and procedures to evaluate treatment response and side effects:

* Medical history and physical examination
* Blood tests
* X-rays and various scans (nuclear medicine/CT/MRI)
* FACT-B Assessment questionnaire to measure the impact of treatment on the patient's general well-being. The questionnaire is administered before beginning treatment, before each vaccination, and during follow-up visits after completing the treatment. It includes questions on the severity of breast cancer symptoms and the ability to perform normal activities of daily life.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Changing Landscape of Cancer Vaccines-Novel Proteomics Platform for New Antigen Compositions.
   Lokhov PG, Lichtenberg S, Balashova EE. · · 2022 · cited 2× · PMID 35457221 · DOI 10.3390/ijms23084401