DNP-Modified Autologous Tumor Cell Vaccine for Resectable Non-Small Cell Lung Cancer

This study has suspended participant recruitment.
(Suspended until capitalization is completed)
Sponsor:
Information provided by (Responsible Party):
AVAX Technologies
ClinicalTrials.gov Identifier:
NCT00298298
First received: February 28, 2006
Last updated: December 1, 2011
Last verified: December 2011
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


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: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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
Experimental: 2
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
Experimental: 3
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Arkansas
Highlands Oncology Group
Fayetteville, Arkansas, United States, 72703
United States, Pennsylvania
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
AVAX Technologies
Investigators
Study Director: Henry E Schea AVAX Technologies
  More Information

Publications:
Responsible Party: AVAX Technologies
ClinicalTrials.gov Identifier: NCT00298298     History of Changes
Other Study ID Numbers: A/100/0601
Study First Received: February 28, 2006
Last Updated: December 1, 2011
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014