Ignite Creation Date:
2024-05-05 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00300612
Status:
COMPLETED
Last Update Posted:
2020-05-28
First Post:
2006-03-07
Brief Title:
Vaccine Treatment for Advanced Malignant Melanoma
Sponsor:
NewLink Genetics Corporation
Organization:
Lumos Pharma
Study Overview
Official Title:
A Phase III Study of Dorgenmeltucel-L HyperAcute Melanoma an Antitumor Vaccination Using Alpha13Galactosyltransferase Expressing Allogeneic Tumor Cells in Patients With Refractory or Recurrent Malignant Melanoma
Status:
COMPLETED
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
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 malignant melanoma with the genetically engineered HyperAcute-Melanoma vaccine It will establish the proper vaccine dose and will examine side effects and potential benefits of the treatment The vaccine contains killed melanoma 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 malignant melanoma 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 twelve vaccinations two weeks 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 Monthly blood samples will be drawn during the 6 months of vaccine treatment In addition patient follow-up visits will be scheduled every 3 months for the remaining first year 6 months after vaccination and then every 6 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-G Assessment questionnaire to measure the impact of treatment on the patients general well-being The questionnaire is administered before beginning treatment monthly during treatment and during follow-up visits after completing the treatment It includes questions on the severity of cancer symptoms and the ability to perform normal activities of daily life
Patients 18 years of age or older with malignant melanoma 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 twelve vaccinations two weeks 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 Monthly blood samples will be drawn during the 6 months of vaccine treatment In addition patient follow-up visits will be scheduled every 3 months for the remaining first year 6 months after vaccination and then every 6 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-G Assessment questionnaire to measure the impact of treatment on the patients general well-being The questionnaire is administered before beginning treatment monthly during treatment and during follow-up visits after completing the treatment It includes questions on the severity of cancer symptoms and the ability to perform normal activities of daily life
Detailed Description:
According to statistics of the American Cancer Society an estimated 55000 individuals will be diagnosed with malignant melanoma and 8000 will die of the disease this year in the Unites States despite all current therapy This protocol attempts to exploit an approach to melanoma vaccine therapy using a naturally occurring barrier to xenotransplantation in humans in attempt to vaccinate patients against their melanoma The expression of the murine alpha13galactosyltransferase alpha13GT gene results in the cell surface expression of alpha13galactosyl-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 advanced stage melanoma will undergo a series of twelve intradermal injections with a trivalent vaccine composed of irradiated allogeneic melanoma cell lines HAM-1 HAM-2 and HAM-3 These cell lines have been transduced with a recombinant Moloney murine leukemia virus MoMLV-based retroviral vector expressing the murine alpha13GT 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 |
|---|---|---|---|
| OBA0404-640 | None | None | None |