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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
recombinant fowlpox GM-CSF vaccine adjuvant
recombinant fowlpox-CEA(6D)/TRICOM vaccine
recombinant vaccinia-CEA(6D)-TRICOM vaccine
carboplatin
paclitaxel
radiation therapy
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

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

Sites / Locations

  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 7, 2004
Last Updated
June 18, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00091039
Brief Title
Vaccine Therapy, Chemotherapy, and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed With Surgery
Official Title
A Pilot Trial of a CEA/TRICOM-Based Vaccine in Combination With Combined Chemotherapy/Radiotherapy in Patients With Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2005
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
Detailed Description
OBJECTIVES: Primary Determine the safety and feasibility of standard paclitaxel, carboplatin, and radiotherapy in combination with vaccinia-CEA-TRICOM vaccine, fowlpox-CEA-TRICOM vaccine, and recombinant fowlpox GM-CSF vaccine in patients with unresectable stage III non-small cell lung cancer. Secondary Determine clinical response in patients treated with this regimen. Determine time to disease progression and overall median survival of patients treated with this regimen. Determine immunologic response in patients treated with this regimen. OUTLINE: This is a pilot study. Vaccine: Patients receive vaccinia-CEA-TRICOM vaccine subcutaneously (SC) on day 0 and fowlpox-CEA-TRICOM (rF-CEA-TRICOM) vaccine SC on days 14, 29, 43, 57, 70, 91, and 112. Patients also receive recombinant fowlpox GM-CSF (rF-GM-CSF) vaccine SC with each vaccination. Patients with stable or responding disease after day 112 continue to receive rF-CEA-TRICOM and rF-GM-CSF SC every 3 weeks in the absence of disease progression or unacceptable toxicity. Radiotherapy: Patients undergo radiotherapy on days 21-25, 28-32, 35-39, 42-46, 49-53, 56-60, and 63-67. Chemotherapy: Concurrently with radiotherapy, patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 21, 28, 35, 42, 49, 56, and 63. Patients also receive paclitaxel and carboplatin on days 91 and 112 (after completion of radiotherapy). Patients are followed annually for up to 15 years. PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study within 4-6 months.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
recombinant fowlpox GM-CSF vaccine adjuvant
Intervention Type
Biological
Intervention Name(s)
recombinant fowlpox-CEA(6D)/TRICOM vaccine
Intervention Type
Biological
Intervention Name(s)
recombinant vaccinia-CEA(6D)-TRICOM vaccine
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Type
Radiation
Intervention Name(s)
radiation therapy

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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip M. Arlen, MD
Organizational Affiliation
National Cancer Institute (NCI)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892-1182
Country
United States

12. IPD Sharing Statement

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

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