Clinical trial · Interventional
Vaccine Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer
Phase II Trial of Individualized Mutant p53 Peptide-Pulsed Cultured Autologous Dendritic Cells in the Adjuvant Treatment of Patients With Locally Advanced Non-Small Cell Lung Cancer After Standard Therapy
NCT00019929CI-TRIAL-00010885completedPhase 2ClinicalTrials.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 may make the body build an immune response to kill tumor cells. PURPOSE: This phase II trial is studying vaccine therapy given after standard therapy to see how well it works in treating patients with 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| mutant p53 peptide pulsed dendritic cell vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Disease-free survival by CTEP CTC v2.x
- measure
- Overall survival by CTEP CTC v2.x
- measure
- Toxicity by CTEP CTC v2.x
Secondary outcomes (1)
- measure
- Immunological response by ELISPOT before and 2 weeks after last vaccine
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed stage IIIA or IIIB non-small cell lung cancer (NSCLC) with one of the following p53 mutations: * Point mutation altering the protein sequence * Frame-shift mutation with the generation of a novel sequence * No significant pleural effusions visible on plain chest radiography * Must have completed or plan to undergo curative intent therapy for NSCLC * At least 2 courses of neoadjuvant chemotherapy for patients with known N2 or N3 resectable disease OR * At least 55 Gy radiotherapy with concurrent or sequential chemotherapy for patients with unresectable disease * Patients with incidental N2 or N3 disease at time of surgery may receive optional adjuvant chemotherapy and radiotherapy PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * ECOG 0-1 Life expectancy: * Not specified Hematopoietic: * Lymphocyte count greater than 475/mm\^3 * Granulocyte count greater than 1,000/mm\^3 * Platelet count greater than 100,000/mm\^3 Hepatic: * Bilirubin less than 2.0 mg/dL * SGOT less than 3 times normal * Albumin at least 3.0 g/dL * No signs of acute hepatitis B infection * Hepatitis B surface antigen positive allowed provided there are no signs of chronic active hepatitis * No prior hepatitis C infection Renal: * Creatinine less than 2.5 mg/dL * Calcium less than 11.0 mg/dL (corrected for albumin) Cardiovascular: * No myocardial infarction or significant ventricular arrhythmias within the past 6 months Other: * No other malignancy within the past 5 years unless curatively treated and probability of recurrence is less than 5% * HIV negative * No psychiatric or other condition that would preclude study * No serious ongoing infection * No other serious medical condition that would limit life expectancy to less than 2 years * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * At least 4 weeks since prior chemotherapy and no anticipated need for chemotherapy for at least 2 months after vaccinations Endocrine therapy: * At least 4 weeks since prior supraphysiologic steroids and no anticipated need for steroid therapy for at least 2 months after vaccinations Radiotherapy: * See Disease Characteristics * At least 4 weeks since prior radiotherapy and no anticipated need for radiotherapy for at least 2 months after vaccinations Surgery: * See Disease Characteristics Other: * No influenza vaccination if egg allergy present * At least 4 weeks and no greater than 24 weeks since completion of all prior modalities for primary therapy
References
Publications (1)
- BACKGROUNDRead EJ, Carter CS, Lee J, et al.: Clinical scale preparation of antigen-pulsed mature autologous dendritic cells for tumor-specific immunotherapy. [Abstract] ISHAGE 2001 Seventh Annual Symposium A-100, 2001.