Overview

This trial is active, not recruiting.

Condition lung cancer
Treatments ep-2101, incomplete freund's adjuvant
Phase phase 2
Sponsor Epimmune
Start date December 2004
Trial identifier NCT00104780, CDR0000415721, EPIMMUNE-EP2101-201, MCMRC-0461

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Comparison of overall survival with historical controls
time frame:
Safety
time frame:

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title 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)
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).