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Vaccine Therapy in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer

A Phase II, Open Label, Multi-center Study of EP2101 Therapeutic Vaccine in Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer (NSCLC)

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00104780
Enrollment
Unknown
Registered
2005-03-04
Start date
2004-12-31
Completion date
Unknown
Last updated
2013-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer

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 patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.

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 emulsified in montanide ISA-51 with that of historical controls and patients with HLA-A2-negative, stage IIIB or IV or recurrent NSCLC who undergo observation only. * Determine the safety of this vaccine in these patients. Secondary * Determine progression-free survival of patients treated with this vaccine. * Determine the frequency, magnitude, and breadth of cytotoxic and helper T-cell response to vaccine epitopes in patients treated with this vaccine. OUTLINE: This is an open-label, multicenter study. Patients are assigned to 1 of 2 treatment groups according to HLA-A2 status. * Group I (HLA-A2 positive): Patients receive vaccine therapy comprising EP-2101 emulsified in montanide ISA-51 subcutaneously once in weeks 0, 3, 6, 9, 12, and 15. * Group II (HLA-A2 negative): Patients undergo observation in weeks 9 and 18. After completion of study treatment, patients in group I are followed at 3 weeks. All patients are then followed at months 1, 2, 3, 5, and 8, every 3 months for 2 years, and then annually for 2 years. PROJECTED ACCRUAL: A total of 84 patients will be accrued for this study within 1 year.

Interventions

BIOLOGICALEP-2101
BIOLOGICALincomplete Freund's adjuvant

Sponsors

Epimmune
Lead SponsorINDUSTRY

Study design

Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Comparison of overall survival with historical controls
Safety

Secondary

MeasureTime frame
Progression-free survival
Frequency, magnitude, and breadth of cytotoxic and helper T-cell response to vaccine epitopes

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026