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

NCT ID: NCT00104780

Last Updated: 2013-11-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-12-31

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.

Conditions

Lung Cancer

Keywords

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

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

EP-2101

Intervention Type: BIOLOGICAL

incomplete Freund's adjuvant

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Epimmune

INDUSTRY

Sponsor Role: lead

Principal Investigators

Scott Plasman

Role: STUDY_CHAIR

Epimmune

Locations

Cancer Centers of Florida - Ocoee

Ocoee, Florida, United States

New York Oncology Hematology, P. C. at Albany Regional Cancer Care

Albany, New York, United States

Duke Comprehensive Cancer Center

Durham, North Carolina, United States

Dayton Oncology & Hematology, P.A. - Kettering

Kettering, Ohio, United States

Cancer Centers of the Carolinas - Eastside

Greenville, South Carolina, United States

Sarah Cannon Cancer Center at Centennial Medical Center

Nashville, Tennessee, United States

Mary Crowley Medical Research Center at Sammons Cancer Center

Dallas, Texas, United States

Tyler Cancer Center

Tyler, Texas, United States

Cancer Care Northwest - North

Spokane, Washington, United States

Countries

United States

Other Identifiers

EPIMMUNE-EP2101-201

Identifier Type: -

Identifier Source: secondary_id

MCMRC-0461

Identifier Type: -

Identifier Source: secondary_id

CDR0000415721

Identifier Type: -

Identifier Source: org_study_id