Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00073398
Status:
COMPLETED
Last Update Posted:
2020-05-28
First Post:
2003-11-19
Brief Title:
Vaccine Treatment for Advanced Non-Small Cell Lung Cancer
Sponsor:
NewLink Genetics Corporation
Organization:
Lumos Pharma
Study Overview
Official Title:
A Phase III Study of Tergenpumatucel-L HyperAcute Lung an Antitumor Vaccination Using Alpha 13 Galactosyltransferase Expressing Allogeneic Tumor Cells in Patients With Refractory or Recurrent Non-Small Cell Lung Cancer
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 non-small cell lung cancer with the genetically engineered HyperAcute-Lung cancer vaccine It will establish the proper vaccine dose and will examine side effects and potential benefits of the treatment The vaccine contains killed lung 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 non-small cell lung cancer that has recurred or no longer responds to standard treatment may be eligible for this study Candidates will be screened with a medical history and physical examination blood tests urinalysis chest x-rays and lung function testing CT MRI PET and ultrasound scans of the chest 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-L 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 lung cancer symptoms and the ability to perform normal activities of daily life
In addition to the above procedures 3 skin punch biopsies will be done at the vaccination site to look for a local immune response For this procedure an area of skin is numbed with an anesthetic and a 4 mm about 14-inch circular area is removed using a sharp cookie cutter-type instrument Also one blood sample per year will be collected for the next 15 years to monitor the safety of the gene transfer Patients whose lung cancer spreads to the skin superficial soft tissues or a superficial lymph node may be asked to undergo a biopsy of the lesion to see what effect the treatment may be having on the tumor
Patients 18 years of age or older with non-small cell lung cancer that has recurred or no longer responds to standard treatment may be eligible for this study Candidates will be screened with a medical history and physical examination blood tests urinalysis chest x-rays and lung function testing CT MRI PET and ultrasound scans of the chest 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-L 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 lung cancer symptoms and the ability to perform normal activities of daily life
In addition to the above procedures 3 skin punch biopsies will be done at the vaccination site to look for a local immune response For this procedure an area of skin is numbed with an anesthetic and a 4 mm about 14-inch circular area is removed using a sharp cookie cutter-type instrument Also one blood sample per year will be collected for the next 15 years to monitor the safety of the gene transfer Patients whose lung cancer spreads to the skin superficial soft tissues or a superficial lymph node may be asked to undergo a biopsy of the lesion to see what effect the treatment may be having on the tumor
Detailed Description:
Background
Lung cancer remains the leading cause of cancer death with an estimated 174400 new cases and 162400 deaths each year in the US
Despite attempts at early diagnosis and the development of new therapeutic agents there has been only limited improvement in the outcome for patients with advanced lung cancer
A enzyme called alpha13galactosyltranferase alphaGT that is not found in humans can transfer sugars on to proteins in human cells that can make them highly immunogenic and cause them to be rejected by the body
Antitumor vaccination using killed donor human lung cancer cells expressing alphaGT may stimulate immune responses in patients against their own lung cancer because their lung cancer may share antigens with the vaccine cells that have been made more immunogenic by expression of alphaGT
Objectives
Phase I has been completed
Phase II
To assess the tumor response rate of anti-tumor vaccination using irradiated allogeneic lung cancer cell lines genetically engineered to express the murine alpha13galactosyltransferase enzyme in patients with advanced recurrent or refractory non-small cell lung cancer
To assess the immunological response of patients with lung cancer undergoing antitumor vaccination with irradiated allogeneic lung cancer cell lines genetically engineered to express murine alpha13galactosyltransferase
Assess the survival distribution as well as the duration of response
Eligibility
Non-small cell lung cancer Adenocarcinoma squamous cell carcinoma large cell anaplastic carcinoma and bronchoalveolar carcinoma
Stage IV recurrent or treatment refractory disease
No exclusion for prior therapy Prior therapy may include surgery radiation immunotherapy and chemotherapy regimens EGFR inhibitors or monoclonal antibodies are included as chemotherapy
Patients must have a granulocyte count of greater than or equal to 1000microL platelets greater than or equal to 100000microL hemoglobin greater than 100 gmdL albumin greater than or equal to 30 gmdL and acceptable hepatic and renal function
No systemic corticosteroids
Design Phase II
Patients will be intradermally vaccinated with 300 million alpha13galactosyltranferase-expressing vaccine cells every 2-weeks to complete a total of eight vaccinations
Patients will be monitored for tumor and immunological responses and safety
Lung cancer remains the leading cause of cancer death with an estimated 174400 new cases and 162400 deaths each year in the US
Despite attempts at early diagnosis and the development of new therapeutic agents there has been only limited improvement in the outcome for patients with advanced lung cancer
A enzyme called alpha13galactosyltranferase alphaGT that is not found in humans can transfer sugars on to proteins in human cells that can make them highly immunogenic and cause them to be rejected by the body
Antitumor vaccination using killed donor human lung cancer cells expressing alphaGT may stimulate immune responses in patients against their own lung cancer because their lung cancer may share antigens with the vaccine cells that have been made more immunogenic by expression of alphaGT
Objectives
Phase I has been completed
Phase II
To assess the tumor response rate of anti-tumor vaccination using irradiated allogeneic lung cancer cell lines genetically engineered to express the murine alpha13galactosyltransferase enzyme in patients with advanced recurrent or refractory non-small cell lung cancer
To assess the immunological response of patients with lung cancer undergoing antitumor vaccination with irradiated allogeneic lung cancer cell lines genetically engineered to express murine alpha13galactosyltransferase
Assess the survival distribution as well as the duration of response
Eligibility
Non-small cell lung cancer Adenocarcinoma squamous cell carcinoma large cell anaplastic carcinoma and bronchoalveolar carcinoma
Stage IV recurrent or treatment refractory disease
No exclusion for prior therapy Prior therapy may include surgery radiation immunotherapy and chemotherapy regimens EGFR inhibitors or monoclonal antibodies are included as chemotherapy
Patients must have a granulocyte count of greater than or equal to 1000microL platelets greater than or equal to 100000microL hemoglobin greater than 100 gmdL albumin greater than or equal to 30 gmdL and acceptable hepatic and renal function
No systemic corticosteroids
Design Phase II
Patients will be intradermally vaccinated with 300 million alpha13galactosyltranferase-expressing vaccine cells every 2-weeks to complete a total of eight vaccinations
Patients will be monitored for tumor and immunological responses and safety
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 |
|---|---|---|---|
| 04-C-0049 | None | None | None |