Status:
TERMINATED
DNP-Modified Autologous Tumor Cell Vaccine for Resectable Non-Small Cell Lung Cancer
Lead Sponsor:
AVAX Technologies
Conditions:
Non-Small Cell Lung Cancer - Completely Resectable
Eligibility:
All Genders
Phase:
PHASE1
PHASE2
Brief Summary
To determine if a vaccine made from patient's own tumor tissue can stimulate an immune response against the patient's tumor cells. To determine the safety of the vaccine
Detailed Description
Study Objectives: To study the toxicity, safety and delayed-type hypersensitivity (DTH) responses of DNP-modified autologous tumor cell vaccine (L-Vax) in patients with resectable NSCLC: * To determi...
Eligibility Criteria
Inclusion
- Histologically documented stage IA, IB, IIA, IIB or IIIA NSCLC that is completely resectable and does not require post-operative radiation therapy or peri-operative chemotherapy
- Excision of the tumor and harvesting of tumor mass yielding adequate cells for vaccine manufacture and DTH testing
- Successful preparation and lot release of vaccines and of DTH testing material containing DNP-modified tumor cells
- Minimum of 3 and maximum of 8 weeks since the surgery
- Expected survival of at least 6 months
- Karnofsky performance status ³ 80
- Signed informed consent
Exclusion
- Alkaline phosphatase \> 2.5 x ULN
- Total bilirubin \> 2.0 mg/dL
- Creatinine \> 2.0 mg/dL
- Hemoglobin \< 10.0 g/dL
- WBC \< 3,000 /mm3
- Platelet count \< 100,000/mm3
- Chemotherapy - pre-operative or post-operative (except as designated in protocol)
- Radiation therapy to lung - pre-operative or post-operative
- Any major field radiotherapy within 6 months prior to participation in the study
- Immunotherapy (interferons, tumor necrosis factor, other cytokines \[e.g., interleukins\], biological response modifiers, or monoclonal antibodies) within 4 weeks prior to participation in the study
- Prior splenectomy
- Concurrent use of systemic steroids, except for the period of administration of the adjuvant chemotherapy, as per Section 8.6 (months 4-7)(Note: Topical steroid therapies \[applied to the skin\] are allowed, provided these are not applied to limbs injected with vaccine or skin test materials. Inhaled aerosol steroids are allowed.)
- Concurrent use of immunosuppressive drugs, except for the period of administration of the adjuvant chemotherapy (months 4-7)
- Concurrent use of antitubercular drugs (isoniazid, rifampin, streptomycin)
- Other malignancy within 5 years except curatively treated non-melanomatous skin cancer and curatively treated carcinoma in situ of the uterine cervix, or early stage (stage A or B1) prostate cancer
- Concurrent autoimmune diseases, e.g., systemic lupus erythematosus, multiple sclerosis or ankylosing spondylitis
- Concurrent medical condition that would preclude compliance or immunologic response to study treatment
- Concurrent serious infection or other serious medical condition
- Receipt of any investigational medication within 4 weeks prior to participation in the study
- Pregnancy or lactation (serum b-human chorionic gonadotropin \[b-HCG\] test must be negative in fertile women at screening visit)
- Active tuberculosis or a past history of tuberculosis
- PPD positive (³ 5 mm to 5TU)
- Known gentamicin sensitivity
- Anergic, defined by the inability to make a DTH to at least one of the following: candida, mumps, tetanus or trichophyton (based, except for the period of administration of the adjuvant chemotherapy (months 4-7) upon availability)
- Vaccine lot release failure
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00298298
Start Date
January 1 2006
End Date
January 1 2014
Last Update
December 3 2015
Active Locations (2)
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1
Highlands Oncology Group
Fayetteville, Arkansas, United States, 72703
2
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States, 19104