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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00091039
First received: September 7, 2004
Last updated: June 18, 2013
Last verified: December 2005
  Purpose

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.


Condition Intervention
Lung Cancer
Biological: recombinant fowlpox GM-CSF vaccine adjuvant
Biological: recombinant fowlpox-CEA(6D)/TRICOM vaccine
Biological: recombinant vaccinia-CEA(6D)-TRICOM vaccine
Drug: carboplatin
Drug: paclitaxel
Radiation: radiation therapy

Study Type: Interventional
Study Design: Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: August 2004
Study Completion Date: February 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00091039

Locations
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
Investigators
Principal Investigator: Philip M. Arlen, MD National Cancer Institute (NCI)
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00091039     History of Changes
Obsolete Identifiers: NCT00088725
Other Study ID Numbers: CDR0000383146, NCI-04-C-0252, NCI-6439
Study First Received: September 7, 2004
Last Updated: June 18, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Metronidazole
Carboplatin
Paclitaxel
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antiprotozoal Agents
Antiparasitic Agents
Radiation-Sensitizing Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 19, 2014