Ignite Creation Date:
2024-05-06 @ 2:22 PM
Last Modification Date:
2024-10-26 @ 1:30 PM
Study NCT ID:
NCT04298606
Status:
RECRUITING
Last Update Posted:
2023-08-01
First Post:
2020-03-04
Brief Title:
A Vaccine CIMAvax-EGF for the Prevention of Lung Cancer Development or Recurrence
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
A Phase 0 Study of CIMAvax-EGF Vaccine in Patients Who Are at High Risk for Lung Cancer and Lung Cancer Survivors at Risk for Recurrence
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This early phase I trial studies the side effects of a vaccine called CIMAvax-EGF and to see how well it works in preventing lung cancer from developing in patients at high risk for lung cancer or coming back recurrence in stage IB-IIIA non-small cell lung cancer survivors In many cancers such as lung cancer there is a protein receptor called EGFR epidermal growth factor receptor that is overexpressed within these cancers Activation of EGFR has shown to lead to tumor growth and development Previous studies have indicated that EGFR activation is present in the airways of cancer-free subjects as well CIMAvax-EGF vaccine works by causing the body to make antibodies against EGF that is being produced that could be possibly driving the risk for developing cancer
Detailed Description:
PRIMARY OBJECTIVES
I To determine the efficacy of the vaccine based on circulating EGF and anti-EGF antibodies
II To access the molecular profile of blood bronchial and nasal brushes and bronchial biopsies to identify molecular markers associated with treatment and response
III To establish the safety of recombinant human EGF-rP64Kmontanide ISA 51 vaccine CIMAvax-EGF treatment in cancer-free individuals using the Cancer Therapy Evaluation Program CTEP National Cancer Institute NCI Common Terminology Criteria for Adverse Events CTCAE version 5
SECONDARY OBJECTIVE
I To evaluate quality of life score changes using European Organization for the Research and Treatment of Cancer EORTC Quality of Life Questionnaire QLQ-Core 30 C30 in patients who are at high risk for development of lung cancer or recurrence during CIMAvax-EGF treatment
OUTLINE
LOADING PHASE Patients receive recombinant human EGF-rP64Kmontanide ISA 51 vaccine intramuscularly IM at 0 2 4 and 6 weeks in the absence of disease progression or unacceptable toxicity
MAINTENANCE PHASE Patients receive recombinant human EGF-rP64Kmontanide ISA 51 vaccine IM once every 4 weeks Q4W in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up for 60 days
I To determine the efficacy of the vaccine based on circulating EGF and anti-EGF antibodies
II To access the molecular profile of blood bronchial and nasal brushes and bronchial biopsies to identify molecular markers associated with treatment and response
III To establish the safety of recombinant human EGF-rP64Kmontanide ISA 51 vaccine CIMAvax-EGF treatment in cancer-free individuals using the Cancer Therapy Evaluation Program CTEP National Cancer Institute NCI Common Terminology Criteria for Adverse Events CTCAE version 5
SECONDARY OBJECTIVE
I To evaluate quality of life score changes using European Organization for the Research and Treatment of Cancer EORTC Quality of Life Questionnaire QLQ-Core 30 C30 in patients who are at high risk for development of lung cancer or recurrence during CIMAvax-EGF treatment
OUTLINE
LOADING PHASE Patients receive recombinant human EGF-rP64Kmontanide ISA 51 vaccine intramuscularly IM at 0 2 4 and 6 weeks in the absence of disease progression or unacceptable toxicity
MAINTENANCE PHASE Patients receive recombinant human EGF-rP64Kmontanide ISA 51 vaccine IM once every 4 weeks Q4W in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up for 60 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2019-08720 | REGISTRY | None | None |
| I 511919 | OTHER | Roswell Park Cancer Institute | None |