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Pilot Study of Vaccinia-CEA-TRICOM Vaccine, Fowlpox-CEA-TRICOM Vaccine, and Recombinant Fowlpox GM-CSF Vaccine With Paclitaxel, Carboplatin, and Radiotherapy in Patients With Unresectable Stage III Non-Small Cell Lung Cancer
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outline Trial Contact Information Registry Information
Alternate Title
Vaccine Therapy, Chemotherapy, and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed With Surgery
Basic Trial Information
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Protocol IDs
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No phase specified
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Treatment
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Completed
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18 and over
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NCI
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NCI-04-C-0252 NCI-6439, 6439, NCT00091039
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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.
Entry 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
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
Patient Characteristics:
Age Performance status Life expectancy Hematopoietic - Granulocyte count ≥ 1,500/mm3
- Platelet count ≥ 100,000/mm3
- Absolute lymphocyte count ≥ 600/mm3
- 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
Expected Enrollment A total of 10 patients will be accrued for this study within 4-6 months. 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.
Trial Contact Information
Trial Lead Organizations NCI - Center for Cancer Research | | | Philip Arlen, MD, Principal investigator | | | |
Registry Information | | 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) | | Trial Start Date | | 2004-08-11 | | Registered in ClinicalTrials.gov | | NCT00091039 | | Date Submitted to PDQ | | 2004-07-21 | | Information Last Verified | | 2005-12-07 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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