Clinical trial · Interventional
Allogeneic Cellular Vaccine 1650-G for Non-Small Cell Lung Cancer
Allogeneic Cellular Vaccine 1650-G for Non-Small Cell Lung Cancer (NSCLC)
NCT00654030CI-TRIAL-00032413completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 1650-G Vaccine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1650-G Vaccine
- description
- Patients receive 2 injections of 1650-G Vaccine given 4 weeks apart, for a total of 52 weeks on study.
- interventionNames
- Drug: 1650-G Vaccine
Primary outcomes (1)
- measure
- Number of Participants Responding to the Vaccine
- timeFrame
- 16 weeks after vaccination
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * 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. Exclusion Criteria: * 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 * 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.
References
Publications (3)
- BACKGROUNDHirschowitz 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. PMID 15254048
- BACKGROUNDHirschowitz EA, Hiestand DM, Yannelli JR. Vaccines for lung cancer. J Thorac Oncol. 2006 Jan;1(1):93-104. PMID 17409835
- RESULTHirschowitz 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. PMID 21150468