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DNP-Modified Autologous Tumor Cell Vaccine for Resectable Non-Small Cell Lung Cancer
This study is currently recruiting participants.
Verified by AVAX Technologies, December 2008
First Received: February 28, 2006   Last Updated: December 3, 2008   History of Changes
Sponsored by: AVAX Technologies
Information provided by: AVAX Technologies
ClinicalTrials.gov Identifier: NCT00298298
  Purpose

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


Condition Intervention Phase
Non-Small Cell Lung Cancer - Completely Resectable
Biological: L-Vax: Autologous, DNP-Modified NSCLC Vaccine
Phase I
Phase II

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by AVAX Technologies:

Primary Outcome Measures:
  • Cell-mediated immunity to autologous tumor cells. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 42
Study Start Date: January 2006
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
5 million autologous, DNP-modified NSCLC cells
Biological: L-Vax: Autologous, DNP-Modified NSCLC Vaccine
autologous, DNP-modified NSCLC cells in suspension dosage - depends on arm route - intradermal frequency - weekly x7, booster at 6 months
2: Experimental
2.5 million autologous, DNP-modified NSCLC cells
Biological: L-Vax: Autologous, DNP-Modified NSCLC Vaccine
autologous, DNP-modified NSCLC cells in suspension dosage - depends on arm route - intradermal frequency - weekly x7, booster at 6 months
3: Experimental
0.5 million autologous, DNP-modified NSCLC cells
Biological: L-Vax: Autologous, DNP-Modified NSCLC Vaccine
autologous, DNP-modified NSCLC cells in suspension dosage - depends on arm route - intradermal frequency - weekly x7, booster at 6 months

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00298298

Locations
United States, Arkansas
Highlands Oncology Group Recruiting
Fayetteville, Arkansas, United States, 72703
Contact: Kim Davison, RN     479-587-1700 ext 143     kdavison@hogonc.com    
Principal Investigator: Daniel S. Bradford, MD            
United States, Pennsylvania
University of Pennsylvania Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Jennifer Beecham, RN     215-662-9647     Jennifer.Beecham@uphs.upenn.edu    
Contact: Joseph Friedberg, ND     215-662-9640     Joseph.Friedberg@uphs.upenn.edu    
Principal Investigator: Joseph Friedberg, MD            
Sponsors and Collaborators
AVAX Technologies
Investigators
Study Director: Francois Martelet, MD AVAX Technologies
  More Information

Publications:
Responsible Party: AVAX Technologies ( Francois Martelet, MD - Chief Executive Officer )
Study ID Numbers: A/100/0601
Study First Received: February 28, 2006
Last Updated: December 3, 2008
ClinicalTrials.gov Identifier: NCT00298298     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by AVAX Technologies:
lung cancer
non-small cell lung cancere
vaccine
immunotherapy

Study placed in the following topic categories:
Thoracic Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Non-small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on May 06, 2009