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

Primary Purpose

Lung Cancer

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
EP-2101
incomplete Freund's adjuvant
Sponsored by
Epimmune
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cancer Centers of Florida - Ocoee
  • New York Oncology Hematology, P. C. at Albany Regional Cancer Care
  • Duke Comprehensive Cancer Center
  • Dayton Oncology & Hematology, P.A. - Kettering
  • Cancer Centers of the Carolinas - Eastside
  • Sarah Cannon Cancer Center at Centennial Medical Center
  • Mary Crowley Medical Research Center at Sammons Cancer Center
  • Tyler Cancer Center
  • Cancer Care Northwest - North

Outcomes

Primary Outcome Measures

Comparison of overall survival with historical controls
Safety

Secondary Outcome Measures

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

Full Information

First Posted
March 3, 2005
Last Updated
November 5, 2013
Sponsor
Epimmune
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1. Study Identification

Unique Protocol Identification Number
NCT00104780
Brief Title
Vaccine Therapy in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2006
Overall Recruitment Status
Unknown status
Study Start Date
December 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Epimmune

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
EP-2101
Intervention Type
Biological
Intervention Name(s)
incomplete Freund's adjuvant
Primary Outcome Measure Information:
Title
Comparison of overall survival with historical controls
Title
Safety
Secondary Outcome Measure Information:
Title
Progression-free survival
Title
Frequency, magnitude, and breadth of cytotoxic and helper T-cell response to vaccine epitopes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Plasman
Organizational Affiliation
Epimmune
Official's Role
Study Chair
Facility Information:
Facility Name
Cancer Centers of Florida - Ocoee
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
New York Oncology Hematology, P. C. at Albany Regional Cancer Care
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Dayton Oncology & Hematology, P.A. - Kettering
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
Cancer Centers of the Carolinas - Eastside
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Sarah Cannon Cancer Center at Centennial Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Mary Crowley Medical Research Center at Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Tyler Cancer Center
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Cancer Care Northwest - North
City
Spokane
State/Province
Washington
ZIP/Postal Code
99218
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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