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

Lung Cancer Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00104780
• Other study ID #: CDR0000415721
• Secondary ID: EPIMMUNE-EP2101-
• Status: Active, not recruiting
• Phase: Phase 2
• First received: March 3, 2005
• Last updated: November 5, 2013
• Start date: December 2004

Study information

• Verified date: March 2006
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Biological:
• EP-2101

• incomplete Freund's adjuvant

Locations

Country	Name	City	State
United States	New York Oncology Hematology, P. C. at Albany Regional Cancer Care	Albany	New York
United States	Mary Crowley Medical Research Center at Sammons Cancer Center	Dallas	Texas
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	Cancer Centers of the Carolinas - Eastside	Greenville	South Carolina
United States	Dayton Oncology & Hematology, P.A. - Kettering	Kettering	Ohio
United States	Sarah Cannon Cancer Center at Centennial Medical Center	Nashville	Tennessee
United States	Cancer Centers of Florida - Ocoee	Ocoee	Florida
United States	Cancer Care Northwest - North	Spokane	Washington
United States	Tyler Cancer Center	Tyler	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Epimmune

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of overall survival with historical controls			No
Primary	Safety			Yes
Secondary	Progression-free survival			No
Secondary	Frequency, magnitude, and breadth of cytotoxic and helper T-cell response to vaccine epitopes			Yes