Status:
UNKNOWN
Vaccine Therapy in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
Lead Sponsor:
Epimmune
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Vaccines made from peptides 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 pa...
Detailed Description
OBJECTIVES: Primary * Compare the overall survival of patients with HLA-A2-positive, stage IIIB or IV or recurrent non-small cell lung cancer (NSCLC) treated with vaccine therapy comprising EP-2101 ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed non-small cell lung cancer meeting 1 of the following stage criteria:
- Stage IIIB disease
- Stage IV disease
- Recurrent disease
- HLA-A2-positive disease
- HLA-A2 negative patients are eligible to enroll in group II (observation) only
- Measurable disease
- Estimated tumor volume ≤ 125 cc
- No CNS signs or symptoms of brain metastases
- Brain metastases that are clinically stable for ≥ 2 months AND do not require anticonvulsants or systemic steroids are allowed
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- ECOG 0-1
- Life expectancy
- At least 12 weeks
- Hematopoietic
- Hemoglobin ≥ 10 g/dL
- Platelet count \> 100,000/mm\^3
- WBC \> 3,000/mm\^3
- Absolute neutrophil count \> 1,500/mm\^3
- Absolute lymphocyte count \> 500/mm\^3
- Hepatic
- AST and ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN for patients with liver involvement by tumor)
- Bilirubin ≤ 2.0 mg/dL (3.0 mg/dL for patients with liver involvement by tumor)
- Albumin ≥ 2.5 g/dL
- Alkaline phosphatase ≤ 2.5 times ULN
- No history of hepatitis B or C positivity
- Renal
- Creatinine ≤ 2 times ULN
- Immunologic
- No history of any of the following active conditions:
- Systemic lupus erythematosus
- Scleroderma
- Connective tissue disease
- Sjögren's syndrome
- Multiple sclerosis
- Rheumatoid arthritis
- Inflammatory bowel disease
- No history of HIV positivity
- No history of serious adverse reaction, including anaphylaxis, or hypersensitivity to study vaccine or to any of its components
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 weeks after completion of study treatment
- No other malignancy within the past 5 years except curatively excised nonmelanoma skin cancer or surgically cured carcinoma in situ of the cervix
- No other acute medical condition that would preclude study treatment
- No mental or psychiatric condition that would preclude study compliance
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- More than 1 month since prior interferon therapy
- More than 1 month since prior interleukin therapy
- No prior cancer vaccine therapy, including participation in a vaccine study
- Chemotherapy
- At least 4 weeks since prior chemotherapy
- Endocrine therapy
- See Disease Characteristics
- More than 1 month since prior systemic corticosteroids except stable doses of inhaled corticosteroids
- Radiotherapy
- At least 4 weeks since prior radiotherapy
- Surgery
- Not specified
- Other
- No concurrent participation in another investigational study
Exclusion
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00104780
Start Date
December 1 2004
Last Update
November 6 2013
Active Locations (9)
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1
Cancer Centers of Florida - Ocoee
Ocoee, Florida, United States, 34761
2
New York Oncology Hematology, P. C. at Albany Regional Cancer Care
Albany, New York, United States, 12208
3
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
4
Dayton Oncology & Hematology, P.A. - Kettering
Kettering, Ohio, United States, 45409