Status:
COMPLETED
Vaccine Therapy in Treating Patients With Stage I, Stage II, or Stage III Non-small Cell Lung Cancer
Lead Sponsor:
Edward Hirschowitz
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
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 studyin...
Detailed Description
OBJECTIVES: * Determine the immunologic effects of adjuvant vaccine therapy comprising autologous dendritic cells loaded with allogeneic non-small cell lung cancer (NSCLC) cells in patients with unre...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00103116
Start Date
October 1 2004
End Date
April 1 2008
Last Update
April 4 2017
Active Locations (1)
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1
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States, 40536-0293