Non-Small Cell Lung Cancer (NSCLC) Clinical Trial
— VTNSCLCOfficial title:
Intratumoral Genetic Therapy for Lung Cancer
Verified date | January 2018 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine the dose that the vaccine can be given safely to patients when injected directly into the lung tumor, without any serious side effects.
Status | Terminated |
Enrollment | 1 |
Est. completion date | March 1, 2017 |
Est. primary completion date | March 1, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility |
Inclusion Criteria: Screening, physical exams, blood draws, CT scans, and follow-up will be performed at VA Greater Los Angeles. All interventional procedures including leukapheresis, CT guided/bronchoscopic biopsies and vaccine injections will be performed at University of California Los Angeles (UCLA). - Adults over the age of 21 capable of giving informed consent - Pathologically confirmed non-small cell lung cancer (NSCLC) - Stage IIIB, IV or recurrent disease - Progressive disease despite one or more prior chemotherapy regimens as standard of care OR patient refusal of standard chemotherapy - Measurable metastatic disease by RECIST guidelines - Patients with a major endobronchial lesion in the segmental, lobar, or mainstem bronchus with complete obstruction of the airway may be eligible for bronchoscopic injection provided there is no evidence of respiratory failure (defined as SaO2 at least 90% on room air, PCO2 less than, or equal to 45 mm Hg, or FEV1 greater than 1.0L) - Patients with an endobronchial lesion in the segmental bronchus with variable stenosis (not completely obstructed) and not amenable to standard palliative airway treatments (i.e., laser and stenting) may be eligible for bronchoscopic injection if there is no indication of respiratory failure as defined above - Patient with bullous disease may undergo CT-guided transthoracic injection provided the targeted tumor has an intended needle path without crossing bullae - ECOG performance status 0-2 - BUN less than or equal to 40 OR serum creatinine less than 2 Serum total bilirubin less than or equal to 1.5 OR serum transaminases less than or equal to 2.5 times upper limit of normal (ULN) - Negative pregnancy test (if applicable) - Fertile patients must use effective contraception - More than 14 days since prior acute therapy for viral, bacterial, or fungal infections - More than 30 days since prior and no concurrent corticosteroids - More than 15 days since prior radiotherapy - More than 30 days since prior chemotherapy, or non-cytotoxic investigational agents Exclusion Criteria: - Active CNS metastases (i.e., progression of CNS disease during the past 30 days without intervention) - Evidence of coagulopathy, defined as PT and/or PTT more than 1.5 times ULN or platelets more than or equal to 100,000/mm3. - Evidence of leukoplakia, defined as absolute neutrophil count more than or equal to 1,500/mm3 - Evidence of respiratory failure (defined as SaO2 less than 90% on room air, PCO2 more than 45 mm Hg, or FEV1 less than 1.0 L - NYHA class III-IV within the past year - Myocardial infarction within the past year - Comorbid disease or medical condition that would impair the ability of the patient to receive or comply with the study protocol - Acute viral, bacterial or fungal infection that requires specific therapy - HIV positive - Hypersensitivity to any reagents used in the study - Signs or sensitivity of acute adenoviral infection (i.e., conjunctivitis or documented adenoviral upper respiratory infection) - Pregnant or nursing - Prior organ allograft |
Country | Name | City | State |
---|---|---|---|
United States | VA Greater Los Angeles Healthcare System, West Los Angeles, CA | West Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development | Jonsson Comprehensive Cancer Center, National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum Tolerated Dose (MTD) | Toxicity as measured by NCI Common Toxicity Criteria | 28 Days | |
Secondary | Disease status at days 28 and 56 days | Immune response assessment by antigen-specific interferon gamma (IFNy) Enzyme-Linked ImmunoSpot (ELISPOT) assays on days 0, 28, and 56 | 28 and 56 Days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06040541 -
Study of RMC-9805 in Participants With KRASG12D-Mutant Solid Tumors
|
Phase 1 | |
Recruiting |
NCT05107674 -
A Study of NX-1607 in Adults With Advanced Malignancies
|
Phase 1 | |
Active, not recruiting |
NCT03667820 -
Study of Osimertinib and Stereotactic Ablative Radiation (SABR) in EGFR Mutant NSCLC
|
Phase 2 | |
Completed |
NCT02025114 -
Selumetinib in Combination With Gefitinib in NSCLC Patients
|
Phase 1/Phase 2 | |
Recruiting |
NCT01994057 -
A Retrospective Study of EGFR-TKIs,Gefitinib, Erlotinib and Osimertinib in NSCLC Patients Treatment
|
||
Completed |
NCT01438307 -
Phase II Study of Cabazitaxel-XRP6258 in Advanced Non-Small Cell Lung Cancer
|
Phase 2 | |
Completed |
NCT01193959 -
Pemetrexed in Advanced Non-small Cell Lung Cancer
|
||
Recruiting |
NCT01028729 -
A Study of Endostar Combined With Chemotherapy Followed by Endostar Maintenance Therapy to Treat Advanced Non-small Cell Lung Cancer (NSCLC)
|
Phase 4 | |
Completed |
NCT00770588 -
Assess the Efficacy, Safety and Tolerability of Gefitinib (Iressa® 250mg) as Maintenance Therapy in Locally Advanced or Metastatic (Stage IIIB/IV) Non Small Cell Lung Cancer (NSCLC)
|
Phase 4 | |
Recruiting |
NCT05462717 -
Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors
|
Phase 1 | |
Completed |
NCT01951157 -
A Clinical Study in Three-arm of Lurbinectedin (PM01183) Alone or in Combination With Gemcitabine and a Control Arm With Docetaxel as Second Line Treatment in Non-Small Cell Lung Cancer (NSCLC) Patients
|
Phase 2 | |
Recruiting |
NCT01964157 -
An Open-label, Multicenter, Phase II Study of LDK378 in Patients With Non-small Cell Lung Cancer Harboring ROS1 Rearrangement
|
Phase 2 | |
Active, not recruiting |
NCT04026412 -
A Study of Nivolumab and Ipilimumab in Untreated Participants With Stage 3 Non-small Cell Lung Cancer (NSCLC) That is Unable or Not Planned to be Removed by Surgery
|
Phase 3 | |
Recruiting |
NCT05585320 -
A Phase 1/2a Study of IMM-1-104 in Participants With Previously Treated, RAS-Mutant, Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03260491 -
U3-1402 in Metastatic or Unresectable Non-Small Cell Lung Cancer
|
Phase 1 | |
Completed |
NCT05207423 -
A Chart Review Study of Adults With Advanced NSCLC
|
||
Terminated |
NCT02608528 -
Serial [18F]Fluorodeoxyglucose ([18F]FDG )PET/CT as a Biomarker of Therapeutic Response in Anti-PD1/PDL1 Therapy
|
||
Completed |
NCT01463423 -
Individualized Lung Tumor Stereotactic Ablative Radiotherapy (iSABR)
|
N/A | |
Recruiting |
NCT02927340 -
A Study of Lorlatinib in Advanced ALK and ROS1 Rearranged Lung Cancer With CNS Metastasis in the Absence of Measurable Extracranial Lesions
|
Phase 2 | |
Recruiting |
NCT02521051 -
Phase I/II Trial of Alectinib and Bevacizumab in Patients With Advanced, Anaplastic Lymphoma Kinase (ALK)-Positive, Non-Small Cell Lung Cancer
|
Phase 1/Phase 2 |