Clinical trial · Interventional
Vaccine Therapy in Patients With Stages IIIB/IV Non-Small Cell Lung Cancer Who Have Finished First-Line Chemotherapy
Phase I/II Clinical Trial of Immunotherapy With an Allogeneic B7.1/HLA-A1 Transfected Tumor Cell Vaccine in Patients With Stages IIIB/IV Non-Small Cell Lung Cancer That Have Completed First Line Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Per request of Principal Investigator this study was closed.
Summary
Brief summary (as posted)
RATIONALE: Vaccines made from gene-modified tumor cells may help the body build an immune response to kill tumor cells. PURPOSE: This randomized phase I/II trial is studying the side effects of vaccine therapy and to see how well it works in treating patients with stage IIIB or stage IV non-small cell lung cancer who have finished first-line chemotherapy.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Allogeneic B7.1/HLA-A1 | Biological | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I: Allogeneic B7.1/HLA-A1
- description
- Patients will receive Allogeneic B7.1/HLA-A1 vaccine once every other week for 2 courses over 12 weeks, for a maximum of 6 vaccines. Given intradermally.
- interventionNames
- Biological: Allogeneic B7.1/HLA-A1
- type
- PLACEBO_COMPARATOR
- label
- Arm II: Placebo
- description
- Patients receive a placebo vaccine intradermally once every other week for 2 courses over 12 weeks, for a maximum of 6 vaccines.
- interventionNames
- Other: Placebo
Primary outcomes (2)
- measure
- Preliminary Safety Profile (Phase 1)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
INCLUSION CRITERIA * Patients with stage IIIB (non-candidates for radiation) or stage IV pathologically confirmed non-small cell carcinoma of the lung that completed 4-6 cycles of platinum based first line chemotherapy and achieved complete response (CR), partial response (PR) or stable disease. * Last administration of chemotherapy occurred no later than 4 weeks prior to the enrollment date. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2. * Renal Requirements: The calculated creatinine clearance must be at least 50 ml/min. * Pulmonary Function Requirements: * All patients will undergo evaluation of pulmonary function prior to enrollment. * Patients should have a Forced expiratory volume in 1 second (FEV1) more than 30% of the predicted value and/or Diffusing capacity (DLCO) more than 30% of the predicted value with a partial pressure of carbon dioxide (PCO2) \< 45mm. * Any patient enrolled in the protocol whose respiratory symptoms have experienced marked deterioration not related to a known cause (e.g. pneumonia, congestive heart failure (CHF) or pulmonary embolism (PE)) will have request pulmonary function test (PFT) evaluation and if the above parameters are seen will be excluded from the protocol. * Age ≥ 18 years. * Signed informed consent. * Patients should have absolute neutrophil count (ANC) ≥ 1000/mm3; platelets (PLT) ≥ 80,000/mm3. EXCLUSION CRITERIA: * Small cell carcinoma of the lung. * Existing autoimmune disorders such as rheumatoid arthritis, systemic lupus erythematosus, Sjogren's disease etc; colitis, inflammatory bowel disease or pancreatitis within 10 years of study. * Other active malignancies present within the past three years, except for basal and/or squamous cell carcinoma(s) or in situ cervical cancer. * Concomitant steroid or other immunosuppressive therapy. * Active infection, or less than 7 days since therapy for acute infections. * Pericardial effusion. * Currently receiving chemotherapy for another condition (such as arthritis). * Time elapsed greater than 4 weeks since last administration of first line chemotherapy for NSCLC. * Active or symptomatic cardiac disease such as congestive heart failure, angina pectoris or recent myocardial infarction. * Pregnant or lactating women (negative test for pregnancy required of women of childbearing potential). * Refusal in fertile men or women to use effective birth control measures during and for six months after the completion of treatment on study. * Known HIV infection * Untreated or uncontrolled brain metastasis. * Liver Enzymes greater than 3 times the institutional upper limit.
References
Publications (2)
- BACKGROUNDRaez LE, Cassileth PA, Schlesselman JJ, Padmanabhan S, Fisher EZ, Baldie PA, Sridhar K, Podack ER. Induction of CD8 T-cell-Ifn-gamma response and positive clinical outcome after immunization with gene-modified allogeneic tumor cells in advanced non-small-cell lung carcinoma. Cancer Gene Ther. 2003 Nov;10(11):850-8. doi: 10.1038/sj.cgt.7700641. PMID 14605671
- BACKGROUNDFrankowski DJ, Raez J, Manners I, Winnik MA, Khan SA, Spontak RJ. Formation of dispersed nanostructures from poly(ferrocenyldimethylsilane-b-dimethylsiloxane) nanotubes upon exposure to supercritical carbon dioxide. Langmuir. 2004 Oct 12;20(21):9304-14. doi: 10.1021/la049646l. PMID 15461522