Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00090480
Status:
TERMINATED
Last Update Posted:
2020-05-28
First Post:
2004-08-26
Brief Title:
Vaccine Treatment for Advanced Breast Cancer
Sponsor:
NewLink Genetics Corporation
Organization:
Lumos Pharma
Study Overview
Official Title:
A Phase III Study of an Antitumor Vaccination Using Alpha13Galactosyltransferase Expressing Allogeneic Tumor Cells in Patients With Relapsed or Refractory Breast Cancer
Status:
TERMINATED
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Enrollment goals unable to be reached
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 patients 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 medicineCTMRI
FACT-B Assessment questionnaire to measure the impact of treatment on the patients 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
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 medicineCTMRI
FACT-B Assessment questionnaire to measure the impact of treatment on the patients 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
Detailed Description:
According to 2002 statistics of the American Cancer Society an estimated 203500 individuals will be diagnosed with breast cancer and 39600 will die of the disease this year despite all current therapy This protocol attempts to exploit an approach to breast cancer gene therapy using a naturally occurring barrier to xenotransplantation in humans in attempt to vaccinate patients against their breast cancer The expression of the murine alpha 13 galactosyltransferase alpha 13 GT gene results in the cell surface expression of alpha 13 galactosyl-epitopes alpha-gal on membrane glycoproteins and glycolipids These epitopes are the major target of the hyperacute rejection response that occurs when organs are transplanted from non-primate donor species into man Human hosts often have pre-existing anti-alpha-gal antibodies that bind alpha-gal epitopes and lead to rapid activation of complement and cell lysis The pre-existing anti-alpha-gal antibodies found in most individuals are thought to be due to exposure to alpha-gal epitopes that are naturally expressed on normal gut flora leading to chronic immunological stimulation These antibodies may comprise up to 1 of serum IgG In this Phase III trial patients with relapsed or refractory breast cancer will undergo a series of four intradermal injections with a vaccine composed of irradiated allogeneic breast cancer cell lines HAB-1 and HAB-2 that have been transduced with a recombinant Moloney murine leukemia virus MoMLV-based retroviral vector expressing the murine alpha 13 GT gene Endpoints of the study include determination of dose-limiting toxicity DLT maximum tolerated dose MTD tumor and immunological responses
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 20031968 | None | None | None |