Clinical trial · Interventional
Vaccine Therapy in Treating Patients With Stage I, Stage II, or Stage III Non-small Cell Lung Cancer
Autologous Dendritic Cell Vaccines in Non-small Cell Lung Cancer (NSCLC)
NCT00103116CI-TRIAL-00026782completedPhase 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 a person's white blood cells and allogeneic tumor cells may make the body build an effective immune response to kill tumor cells. PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with stage I, stage II, or stage III non-small cell lung cancer.
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 |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous dendritic cell cancer vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Autologous dendritic cell cancer vaccine
- description
- Open label nonrandomized
- interventionNames
- Biological: autologous dendritic cell cancer vaccine
Primary outcomes (1)
- measure
- Number of Participants Showing Immunologic Response to Vaccine Within Six Months of Immunization
- timeFrame
- six months post vaccine
- description
- Antigen specific reaction is measured serially in blood of each participant prior to and through six months post-vaccine. Increase in levels of specific T cell activity from pre vaccine to post vaccine serve as primary measures of an individual's response to vaccine. The number (relative percent) of participants achieving immunologic response to vaccine within 6 month of immunization was the dominant metric of vaccine activity within the study population.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed non-small cell lung cancer (NSCLC)
* Meets 1 of the following stage criteria:
* Completely resected stage I-IIIB disease
* Underwent surgical resection \> 4 weeks but ≤ 4 years ago
* Unresectable stage IIIA or IIIB disease AND previously treated with definitive radiotherapy or chemotherapy \> 6 weeks ago
* Bronchoalveolar carcinomas allowed
* Clinically stable disease by chest x-ray or CT scan within the past 6 weeks
* No progressive disease
* No malignant pleural or pericardial effusions
PATIENT CHARACTERISTICS:
Age
* 18 to 80
Performance status
* ECOG 0-1
Life expectancy
* Not specified
Hematopoietic
* Hemoglobin ≥ 9.0 g/dL
Hepatic
* Bilirubin ≤ 2.5 times upper limit of normal (ULN)
* AST and ALT ≤ 2.5 times ULN
* No known history of infectious hepatitis
Renal
* Creatinine ≤ 3 mg/dL
* Ionized calcium ≥ 0.9 mmol/L (may be replaced)
Cardiovascular
* No known New York Heart Association class III-IV congestive heart failure
* No hemodynamically significant valvular heart disease
* No myocardial infarction within the past 6 months
* No active angina pectoris
* No uncontrolled ventricular arrhythmia
* No stroke within the past year
* No known cerebrovascular disease
* No other significant cardiac disease by echocardiogram, stress test, or risk assessment by cardiologist (for patients suspected of cardiac disease by history or physical exam)
Immunologic
* No known HIV positivity
* No other immunosuppressive disorders, including chronic disorders
Other
* Not pregnant
* Negative pregnancy test
* Potassium ≥ 3.0 mEq/L (may be replaced)
* Able to tolerate modest blood volume and electrolyte shifts during leukapheresis
* No other malignancy
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Prior biologic therapy allowed
* Other concurrent biologic therapy allowed
Chemotherapy
* See Disease Characteristics
* No concurrent chemotherapy
Endocrine therapy
* No concurrent steroids during and for 16 weeks after study treatment
Radiotherapy
* See Disease Characteristics
* No concurrent radiotherapy
Surgery
* See Disease Characteristics
Other
* Prior neoadjuvant or adjuvant therapy for surgically resected patients allowed
* No concurrent shorter courses of immunosuppressive medications during and for 16 weeks after study treatment
* No concurrent chronic immunosuppressive medications
* Concurrent cyclooxygenase-2 inhibitors allowedReferences
Publications (3)
- RESULTHirschowitz EA, Foody T, Hidalgo GE, Yannelli JR. Immunization of NSCLC patients with antigen-pulsed immature autologous dendritic cells. Lung Cancer. 2007 Sep;57(3):365-72. doi: 10.1016/j.lungcan.2007.04.002. Epub 2007 May 16. PMID 17509725
- RESULTHirschowitz 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
- RESULTHirschowitz EA, Yannelli JR. Immunotherapy for lung cancer. Proc Am Thorac Soc. 2009 Apr 15;6(2):224-32. doi: 10.1513/pats.200806-048LC. PMID 19349492