Non-Small Cell Lung Cancer - Completely Resectable Clinical Trial
Official title:
L-Vax: A Feasibility Study Using a DNP-Modified Autologous Tumor Cell Vaccine as Therapy in Patients With Resectable Non-Small Cell Lung Cancer
| Verified date | December 2015 |
| Source | AVAX Technologies |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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
| Status | Terminated |
| Enrollment | 6 |
| Est. completion date | January 2014 |
| Est. primary completion date | January 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - 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 Criteria: 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Highlands Oncology Group | Fayetteville | Arkansas |
| United States | University of Pennsylvania Cancer Center | Philadelphia | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| AVAX Technologies |
United States,
Berd D, Sato T, Cohn H, Maguire HC Jr, Mastrangelo MJ. Treatment of metastatic melanoma with autologous, hapten-modified melanoma vaccine: regression of pulmonary metastases. Int J Cancer. 2001 Nov;94(4):531-9. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Cell-mediated immunity to autologous tumor cells. | 3 months | No | |
| Primary | Safety | 1 year | Yes |