Phase 2
N=32
Vaccine Therapy in Treating Patients With Stage I, Stage II, or Stage III Non-small Cell Lung Cancer
Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00103116 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Number of Participants Showing Immunologic Response to Vaccine Within Six Months of Immunization — 22 participants with immunological response
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- autologous dendritic cell cancer vaccine (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Edward Hirschowitz
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Showing Immunologic Response to Vaccine Within Six Months of Immunization |
22 | — |
| SECONDARY Number of Participants Alive Five Years Post Vaccine |
20 | — |
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 studying how well vaccine therapy works in treating patients with stage I, stage II, or stage III non-small cell lung cancer.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00103116). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.