Clinical trial · Interventional
Vaccine Therapy in Treating Patients Who Are Undergoing Surgery for Stage IB, Stage II, or Stage IIIA Non-Small Cell Lung Cancer
A Phase I Clinical Trial of Mature Autologous Dendritic Cells Loaded With Irradiated Autologous Tumor Cells for the Treatment of Non-Small Cell Lung Cancer (NSCLC)
- 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 tumor cells and white blood cells may make the body build an effective immune response to kill tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients who are undergoing surgery for stage IB, stage II, or stage IIIA 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 (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| autologous tumor cell vaccine | Drug | — | UNRESOLVED |
| biological therapy | Procedure | — | UNRESOLVED |
| conventional surgery | Procedure | — | UNRESOLVED |
| surgery | Procedure | — | UNRESOLVED |
| therapeutic autologous dendritic cells | Drug | — | UNRESOLVED |
| tumor cell derivative vaccine | Procedure | — | UNRESOLVED |
| vaccine therapy | Procedure | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of non-small cell lung cancer * Clinical stage IB-IIIA disease * Candidate for surgical resection as primary treatment for tumor * Surgically resectable tumor ≥ 2.0 cm in diameter * No brain metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Zubrod 0-1 Life expectancy * Not specified Hematopoietic * Platelet count ≥ 100,000/mm\^3 * WBC ≥ 3,000/mm\^3 * Absolute neutrophil count ≥ 1,500/mm\^3 * Hematocrit ≥ 30% Hepatic * Hepatitis B surface antigen negative\* * Hepatitis B core antigen negative\* * Hepatitis C virus negative\* * Bilirubin ≤ 2.0 mg/dL * AST and ALT ≤ 2 times upper limit of normal NOTE: \*Screening performed only if liver enzymes are elevated Renal * Creatinine ≤ 2.2 mg/dL * BUN ≤ 40 mg/dL Pulmonary * FEV\_1 \> 2.0 L (pre-resection) OR * Predicted post-resection FEV\_1 \> 1.0 L * No more than 2 chronic obstructive pulmonary disease exacerbations requiring \> 2 weeks of oral steroids and/or hospitalization within the past year Immunologic * Purified protein derivative (PPD) skin test negative * HIV-1 and HIV-2 negative * No acute infection, including any acute viral, bacterial, or fungal infection requiring specific therapy within the past 7 days * No allergy to study agents * No known autoimmune or collagen vascular disorder Other * Not pregnant or nursing * Fertile patients must use effective contraception * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * No underlying condition that would preclude study therapy PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent anti-tumor necrosis factor agents Chemotherapy * Standard adjuvant chemotherapy for lung cancer allowed provided therapy is completed ≥ 30 days before administration of the first study vaccine * No concurrent cyclophosphamide Endocrine therapy * No concurrent high-dose corticosteroids (e.g., \> 10 mg of prednisone) * Concurrent corticosteroids for minor breathing exacerbations allowed provided patient receives ≤ 2 short courses (≤ 10 days per course) within a 45-day period * No concurrent corticosteroids within 48 hours before or after study vaccine administration Radiotherapy * Standard adjuvant radiotherapy for lung cancer allowed provided therapy is completed ≥ 30 days before administration of the first study vaccine Surgery * No prior organ allograft Other * No concurrent antihistamines within 48 hours before or after study vaccine administration * No concurrent cimetidine or other H2 blockers within 48 hours before or after study vaccine administration * Concurrent antibiotics for minor infection allowed provided patient receives ≤ 2 short courses (≤ 10 days per course) within a 45-day period * No concurrent cyclosporine * No concurrent azathioprine * No other concurrent drugs known to significantly alter immune function * No concurrent cytotoxic therapy * No concurrent participation in another clinical trial involving experimental therapy * No other concurrent anticancer therapy
References
Publications (0)
Data not yet available