DNP-Modified Autologous Tumor Cell Vaccine for Resectable Non-Small Cell Lung Cancer
Stopped early · Phase 1/Phase 2
Conditions studied: Non-Small Cell Lung Cancer - Completely Resectable
In brief
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
Key facts
- Study ID
- NCT00298298
- Run by
- AVAX Technologies
- People needed
- 6
- Starts
- 2006-01-01
- Expected to finish
- 2014-01-01
- Last updated by the study team
- 2015-12-03
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Highlands Oncology Group — Fayetteville, Arkansas, United States
- University of Pennsylvania Cancer Center — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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