Vaccine Therapy in Treating Patients With Stage I, Stage II, or Stage III Non-small Cell Lung Cancer
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.
Checked against the public recordLast updated Apr 4, 2017 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Edward Hirschowitz
- Interventions being studied
- Biological: autologous dendritic cell cancer vaccine
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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 allowed
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Markey Cancer Center at University of Kentucky Chandler Medical CenterLexington, Kentucky
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 4, 2017. Always confirm current availability with the study team.