Non-Small Cell Lung CancerPhase 2NCT00654030
Allogeneic Cellular Vaccine 1650-G for Non-Small Cell Lung Cancer
A Phase 2 study testing 1650-G Vaccine in people with Non-Small Cell Lung Cancer, run by Edward Hirschowitz at 4 sites in United States.
Trial summary
Rationale: Vaccines made from allogeneic tumor cells may help the body build an effective immune response to kill tumor cells. The Purpose of this study is to evaluate the effects of a lung cancer vaccine in patients with Stage I or Stage II Non-Small Cell Lung Cancer (NSCLC) after completion of initial definitive… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- 1650-G Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2006to Nov 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed Stage I or Stage II Non-Small Cell Lung Cancer
- Surgically resected at least 4 weeks ago but not more than 6 months ago
- Bronchoalveolar carcinomas allowed
- Completion of any chemotherapy or radiation given in conjunction with Surgery (neoadjuvant or adjuvant)
- No evidence of disease following initial therapy evidenced by a CXR, CT or PET scan within 6 weeks of enrollment
- ECOG performance status of 0 to 2
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- Adequate organ and marrow function defined as follows:
- Hemoglobin ≥9.0 gm/dL
- Bilirubin < 2.5 x upper limit of normal
- AST <2.5 x upper limit of normal
- ALT <2.5 x upper limit of normal
- Creatinine <3 mg/dL
- Women of childbearing potential must have a negative pregnancy test and be willing to use acceptable methods of contraception through week 16.
Who cannot join
- Cardiovascular disease defined as:
- New York Heart Association Class III or IV (Section 19.2) congestive heart failure
- hemodynamically significant valvular heart disease
- myocardial infarction within the last six months
- active angina pectoris
- uncontrolled ventricular arrhythmias
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- stroke within one year
- known cerebrovascular disease
- History of HIV, infectious hepatitis, or chronic immunosuppressive disease
- concurrent shorter courses of immunosuppressive medications during and for 16 weeks after study treatment
- History of an allergic reactions to any colony stimulating factor (GCSF, GMCSF)
- Female patients must not be pregnant or breastfeeding.
- History of participation in any investigational drug study within 4 weeks preceding initiation of study treatment.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Commonwealth Cancer Center
Danville, Kentucky, 40422
University of Kentucky
Lexington, Kentucky, 40536
University of Louisville Hospital
Louisville, Kentucky, 40202
Owensboro Medical Health System
Owensboro, Kentucky, 42303
About this study
Official title: Allogeneic Cellular Vaccine 1650-G for Non-Small Cell Lung Cancer (NSCLC)
Rationale: Vaccines made from allogeneic tumor cells may help the body build an effective immune response to kill tumor cells.
The Purpose of this study is to evaluate the effects of a lung cancer vaccine in patients with Stage I or Stage II Non-Small Cell Lung Cancer (NSCLC) after completion of initial definitive therapies.
Read the detailed description
The study is an open label investigation of the cellular vaccine called 1650-G. Patients receive 2 vaccine injections intradermally in the thigh given 4 weeks apart. Patients will be followed weekly after each vaccine injection and then monthly for 4 months. Patient follow-up continues with evaluations at 6 months and 1 year after receiving the first vaccine injection. Immunologic responses to the vaccine will be assessed from blood samples obtained at each visit following immunizations.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- 1650-G Vaccine
- Keywords
- Lung Cancer Vaccine, Early Stage Lung Cancer, Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1650-G VaccineDrug
Also called 1650-G Allogeneic Cellular Vaccine
.6ml injection administered intradermally in the thigh at week 0 and week 4
| Study group | Role | What they receive |
|---|---|---|
| 1650-G Vaccine | Experimental | Patients receive 2 injections of 1650-G Vaccine given 4 weeks apart, for a total of 52 weeks on study. Receives: Drug: 1650-G Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Responding to the Vaccine
The endpoint is immunologic response measured by IFN-ELISPOT. It will be reported as the percent of patients responding to vaccine (>2 Standard Deviation increase from baseline levels pre-vaccine). The number of individuals responding (> 2 SD change from baseline vaccine) will provide an approximation of biologic efficacy of the vaccine.
Measured: 16 weeks after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2008 (estimated)
- Study startOct 2006
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edward Hirschowitz
- Sponsor type
- University, hospital or other
- Collaborators
- Kentucky Lung Cancer Research Program
- Responsible party
- Sponsor-investigator, Edward Hirschowitz, University of Kentucky
- Investigators
- Edward A Hirschowitz, MD, Study chair, University of KentuckyJohn R Yannelli, PhD, Study chair, University of KentuckyGoetz H Kloecker, MD, Principal investigator, University of LouisvilleThomas R Baeker, MD, Principal investigator, Commonwealth Cancer CenterDattatraya S Prajapati, MD, Principal investigator, Owensboro Medical Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00654030
- Sponsor's protocol ID
- CTN-0505
- Other IDs
- UKIRB 06-0716-F3R, ULIRB 065.07, CIRB 1079747
- Status last verified
- Mar 2018
- First submitted
- 2 Apr 2008
- Last updated
- 9 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Hirschowitz EA, Foody T, Kryscio R, Dickson L, Sturgill J, Yannelli J. Autologous dendritic cell vaccines for non-small-cell lung cancer. J Clin Oncol. 2004 Jul 15;22(14):2808-15. doi: 10.1200/JCO.2004.01.074.
PubMed 15254048Hirschowitz EA, Hiestand DM, Yannelli JR. Vaccines for lung cancer. J Thorac Oncol. 2006 Jan;1(1):93-104.
PubMed 17409835Hirschowitz EA, Mullins A, Prajapati D, Baeker T, Kloecker G, Foody T, Damron K, Love C, Yannelli JR. Pilot study of 1650-G: a simplified cellular vaccine for lung cancer. J Thorac Oncol. 2011 Jan;6(1):169-73. doi: 10.1097/JTO.0b013e3181fb5c22.
PubMed 21150468
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogeneic Cellular Vaccine 1650-G for Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT00654030
- Acronym / sponsor ID
- CTN-0505
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Lung Cancer Vaccine, Early Stage Lung Cancer, Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Edward HirschowitzUniversity, hospital or other
- Collaborators
- Kentucky Lung Cancer Research Program
- Study start
- Oct 2006
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 7 Apr 2008 (estimated)
- Results
- Posted 20 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rationale: Vaccines made from allogeneic tumor cells may help the body build an effective immune response to kill tumor cells.
The Purpose of this study is to evaluate the effects of a lung cancer vaccine in patients with Stage I or Stage II Non-Small Cell Lung Cancer (NSCLC) after completion of initial definitive therapies.
Detailed description
The study is an open label investigation of the cellular vaccine called 1650-G. Patients receive 2 vaccine injections intradermally in the thigh given 4 weeks apart. Patients will be followed weekly after each vaccine injection and then monthly for 4 months. Patient follow-up continues with evaluations at 6 months and 1 year after receiving the first vaccine injection. Immunologic responses to the vaccine will be assessed from blood samples obtained at each visit following immunizations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1650-G Vaccine | Experimental | Drug: 1650-G VaccinePatients receive 2 injections of 1650-G Vaccine given 4 weeks apart, for a total of 52 weeks on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically confirmed Stage I or Stage II Non-Small Cell Lung Cancer
- Surgically resected at least 4 weeks ago but not more than 6 months ago
- Bronchoalveolar carcinomas allowed
- Completion of any chemotherapy or radiation given in conjunction with Surgery (neoadjuvant or adjuvant)
- No evidence of disease following initial therapy evidenced by a CXR, CT or PET scan within 6 weeks of enrollment
Key exclusion criteria (13 listed)
- Cardiovascular disease defined as:
- History of HIV, infectious hepatitis, or chronic immunosuppressive disease
- concurrent shorter courses of immunosuppressive medications during and for 16 weeks after study treatment
- History of an allergic reactions to any colony stimulating factor (GCSF, GMCSF)
- Female patients must not be pregnant or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1650-G VaccineAlso: 1650-G Allogeneic Cellular Vaccine.6ml injection administered intradermally in the thigh at week 0 and week 4 | Drug | 1650-G Vaccine |
Primary outcome
Number of Participants Responding to the Vaccine
Time frame: 16 weeks after vaccination
The endpoint is immunologic response measured by IFN-ELISPOT. It will be reported as the percent of patients responding to vaccine (>2 Standard Deviation increase from baseline levels pre-vaccine). The number of individuals responding (> 2 SD change from baseline vaccine) will provide an approximation of biologic efficacy of the vaccine.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15254048Hirschowitz EA, Foody T, Kryscio R, Dickson L, Sturgill J, Yannelli J. Autologous dendritic cell vaccines for non-small-cell lung cancer. J Clin Oncol. 2004 Jul 15;22(14):2808-15. doi: 10.1200/JCO.2004.01.074.
- Background: PubMed 17409835Hirschowitz EA, Hiestand DM, Yannelli JR. Vaccines for lung cancer. J Thorac Oncol. 2006 Jan;1(1):93-104.
- Results publication: PubMed 21150468Hirschowitz EA, Mullins A, Prajapati D, Baeker T, Kloecker G, Foody T, Damron K, Love C, Yannelli JR. Pilot study of 1650-G: a simplified cellular vaccine for lung cancer. J Thorac Oncol. 2011 Jan;6(1):169-73. doi: 10.1097/JTO.0b013e3181fb5c22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward A Hirschowitz, MD study chair
University of Kentucky
John R Yannelli, PhD study chair
University of Kentucky
Goetz H Kloecker, MD principal investigator
University of Louisville
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 1650-G Vaccine in people with Non-Small Cell Lung Cancer, run by Edward Hirschowitz at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Responding to the Vaccine (time frame: 16 weeks after vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00654030, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2018.