Status:
TERMINATED
Vaccine Therapy in Treating Patients Who Are Undergoing Surgery for Stage IB, Stage II, or Stage IIIA Non-Small Cell Lung Cancer
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 e...
Detailed Description
OBJECTIVES: Primary * Determine the maximum tolerated dose of adjuvant autologous dendritic cells loaded with irradiated autologous tumor cells in patients with stage IB-IIIA non-small cell lung can...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00098917
Start Date
February 1 2005
Last Update
January 28 2008
Active Locations (1)
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1
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781