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

NCT00104780 | Unknown Phase 2

• 3 other identifiers: CDR0000415721EPIMMUNE-EP2101-201MCMRC-0461
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 9

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.

Conditions

Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Comparison of overall survival with historical controls

• Safety

Secondary Outcomes (2)

• Progression-free survival

• Frequency, magnitude, and breadth of cytotoxic and helper T-cell response to vaccine epitopes

Interventions

EP-2101 BIOLOGICAL

incomplete Freund's adjuvant BIOLOGICAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Epimmune: lead

Study Sites (9)

Cancer Centers of Florida - Ocoee

Ocoee, Florida, 34761, United States

Location

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

Albany, New York, 12208, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Dayton Oncology & Hematology, P.A. - Kettering

Kettering, Ohio, 45409, United States

Location

Cancer Centers of the Carolinas - Eastside

Greenville, South Carolina, 29615, United States

Location

Sarah Cannon Cancer Center at Centennial Medical Center

Nashville, Tennessee, 37203, United States

Location

Mary Crowley Medical Research Center at Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

Tyler Cancer Center

Tyler, Texas, 75702, United States

Location

Cancer Care Northwest - North

Spokane, Washington, 99218, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

incomplete Freund's adjuvant

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• Scott Plasman

  Epimmune

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 3, 2005
• First Posted: March 4, 2005
• Study Start: December 1, 2004
• Last Updated: November 6, 2013

Record last verified: 2006-03

Locations

US (9)