Vaccine Therapy, Chemotherapy, and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed With Surgery

NCT00091039 | Completed

• 3 other identifiers: CDR0000383146NCI-04-C-0252NCI-6439
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Vaccines made from a gene-modified virus may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high energy x-rays to damage tumor cells. Combining vaccine therapy with chemotherapy and radiation therapy may kill more tumor cells. PURPOSE: This clinical trial is studying how well giving vaccine therapy together with paclitaxel, carboplatin, and radiation therapy works in treating patients with stage III non-small cell lung cancer that cannot be removed with surgery.

Conditions

Lung Cancer

Keywords

stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer

Interventions

recombinant fowlpox GM-CSF vaccine adjuvant BIOLOGICAL

recombinant fowlpox-CEA(6D)/TRICOM vaccine BIOLOGICAL

recombinant vaccinia-CEA(6D)-TRICOM vaccine BIOLOGICAL

carboplatin DRUG

paclitaxel DRUG

radiation therapy RADIATION

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 * Stage III (locally advanced) disease * Unresectable disease * Carcinoembryonic antigen (CEA)-positive (staining ≥ 20% of cells) tumor by immunohistochemistry * HLA-A2-positive * No distant metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-1 Life expectancy * At least 6 months Hematopoietic * Granulocyte count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Absolute lymphocyte count ≥ 600/mm\^3 * Hemoglobin ≥ 10 g/dL Hepatic * Bilirubin \< 1.5 mg/dL * AST ≤ 2 times upper limit of normal * Hepatitis B and C negative Renal * Creatinine normal OR * Creatinine clearance \> 60 mL/min Cardiovascular * No unstable or newly diagnosed angina pectoris * No myocardial infarction within the past 6 months * No New York Heart Association class II-IV congestive heart failure Immunologic * HIV negative * No altered immune function * No active or history of eczema * No atopic dermatitis * No autoimmune disease, including any of the following: * Autoimmune neutropenia, thrombocytopenia, or hemolytic anemia * Systemic lupus erythematosus * Sjögren's syndrome * Scleroderma * Myasthenia gravis * Goodpasture's syndrome * Addison's disease * Hashimoto's thyroiditis * Active Graves' disease * Multiple sclerosis * No known history of allergy or serious reaction to prior vaccination with vaccina * No known allergy to eggs * No active or history of extensive psoriasis, severe acneiform rash, impetigo, varicella zoster, burns, or other traumatic or pruritic skin condition Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 4 months after study participation * No history of seizures or encephalitis * Able to avoid close household contact with the following individuals for at least 3 weeks after vaccinia vaccination: * Children under 3 years of age * Pregnant or nursing women * Individuals with a history of or active eczema or other eczematoid skin disorders * Individuals with other acute, chronic, or exfoliative skin conditions (e.g., atopic dermatitis, impetigo, burns, varicella zoster, severe acne, or other open rashes or wounds) * Immunodeficient or immunosuppressed individuals, including HIV-positive persons, by disease or therapy * No other active malignancy within the past 2 years * No other concurrent serious illness PRIOR CONCURRENT THERAPY: Biologic therapy * At least 3 years since prior immunotherapy with related vaccinia and fowlpox vaccines * At least 3 years since prior antigen-specific peptides * No other concurrent immunotherapy Chemotherapy * No prior paclitaxel or carboplatin for lung cancer * At least 3 years since prior chemotherapy * No other concurrent chemotherapy Endocrine therapy * No concurrent steroids, except for any of the following: * Topical steroids * Inhaled steroids for mild or moderate asthma * Dexamethasone as premedication for paclitaxel OR for short-term doses (48-72 hours in duration) to control refractory nausea that is not responding to other antiemetics * Systemic corticosteroids for ≥ grade 3 radiation pneumonitis * No steroid eye-drops for at least 3 weeks after vaccinia vaccination * No concurrent hormonal therapy * No concurrent systemic glucocorticoids Radiotherapy * No prior radiotherapy to the lung fields * No prior thoracic radiotherapy for lung cancer * No other concurrent radiotherapy Surgery * Surgical scars must be healed * No prior splenectomy * No concurrent major surgical procedure Other * Recovered from all prior therapy * No other concurrent anticancer agent or therapy

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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Carboplatin; Paclitaxel; Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Therapeutics

Study Officials

• Philip M. Arlen, MD

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 7, 2004
• First Posted: September 8, 2004
• Study Start: August 1, 2004
• Study Completion: February 1, 2006
• Last Updated: June 20, 2013

Record last verified: 2005-12

Locations

US (1)