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Safety and Immunogenicity of Recombinant DNA and Adenovirus Expressing L523S Protein in Early Stage Non-Small Cell Lung Cancer

This study is currently recruiting participants.
Verified by Corixa Corporation, November 2004

Sponsored by: Corixa Corporation
Information provided by: Corixa Corporation
ClinicalTrials.gov Identifier: NCT00062907
  Purpose

The purpose of this trial is to examine the safety and immunogenicity of a therapeutic vaccine regimen with recombinant DNA and adenovirus expressing L523S protein in patients with early stage non-small cell lung cancer. The vaccine regimen will consist of two fixed doses of recombinant DNA (pVAX/L523S) followed by two doses of recombinant adenovirus (Ad/L523S). The trial will evaluate the dose escalation of Ad/L523S through three cohorts of patients.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Biological: Recombinant DNA- pVAX/L523S
Biological: Recombinant adenovirus- Ad/L523S
Phase I

MedlinePlus related topics:   Cancer    Lung Cancer   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:   Phase I Open-Label Dose Escalation Trial Evaluating The Safety And Immunogenicity Of Sequential Administration Of Recombinant DNA And Adenovirus Expressing L523S Protein In Patients With Early Stage Non-Small Cell Lung Cancer

Further study details as provided by Corixa Corporation:

Estimated Enrollment:   9
Study Start Date:   May 2003

Detailed Description:

The primary objective of the study is to evaluate the safety of the vaccine regimen administered as two doses of pVAX/L523S and two doses of Ad/L523S.

The secondary objectives of the study are:

  • To provide initial evidence as to whether CD8+ and CD4+ T cell responses specific for L523S protein can be elicited by two doses of pVAX/L523S followed by two doses of Ad/L523S
  • To provide initial evidence as to whether antibody responses specific for L523S protein can be elicited by two doses of pVAX/L523S followed by two doses of Ad/L523S
  • To investigate the extent to which dose escalation of Ad/L523S affects the elicited immune response
  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

INCLUSION CRITERIA:

  • Histologically and surgical confirmed diagnosis and stage of IB, IIA, or IIB non-small cell lung cancer (NSCLC) according to the Revised International System for Staging Lung Cancer
  • Primary surgical resection of lung cancer greater than or equal to 4 weeks and less than or equal to 3 years prior to the Day 0 visit
  • No evidence of disease by standard diagnostic tests
  • Chest X-ray and physical examination showing no active disease
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • WBC count greater than or equal to 3,000 cells/mm3 and ANC greater than or equal to 1,500 cells/mm3
  • Hemoglobin value greater than or equal to 10.0 g/dL and a platelet count greater than or equal to 125,000 cells/mm3
  • Adequate renal function (defined as serum creatinine <1.5 times the upper limit of normal for females and males)
  • Normal hepatic function (defined as serum bilirubin <1.5 times the upper limit of normal, AST <2.5 times the upper limit of normal and alkaline phosphatase <1.5 times the upper limit of normal)
  • Ability to understand and willingness to sign an IRB-approved written consent prior to study enrollment
  • Female patients must be greater than or equal to 60 years of age, or greater than or equal to 5 years amenorrhea or surgically sterile
  • Male patients who are capable of fathering a child and whose partners are capable of having a child must agree to use adequate contraception for 6 months after enrollment (for men or women-surgical sterilization; for women-hormonal contraceptives, vaginal ring or IUD)
  • Absolute CD4+ cell count of >200 cells/mm3

EXCLUSION CRITERIA:

  • Received pre- or post-operative radiotherapy
  • Received prior biologic, immunologic, or gene therapy for cancer
  • Received an investigational drug (new chemical entity) within three months of study entry
  • Received antibiotics within 2 weeks of Day 0 visit
  • Received systemic or inhaled corticosteroids or immunosuppressive therapy within 4 weeks of Day 0 visit (Use of topical corticosteroids and/or eye drops containing glucocorticosteroids is acceptable)
  • History of active autoimmune diseases such as, but not limited to, systemic lupus erythematosis, sarcoidosis, rheumatoid arthritis, glomerulonephritis, vasculitis, or inflammatory bowel disease
  • History of bleeding in stools and/or diarrhea within 4 weeks of Day 0 visit
  • History of anaphylaxis or severe allergic reaction to vaccines or unknown allergens
  • Received any commercial vaccine within 2 weeks of Day 0 visit
  • Received a major organ allograft
  • Current or previous diagnosis of paraneoplastic syndrome
  • Evidence of a clinically significant active pulmonary infection, emphysema, FeV1 less than or equal to 50% predicted, DLCO less than or equal to 50% predicted, pulse oximetry less than or equal to 92% at the time of study entry
  • Known to be HIV positive
  • Results of virology screening indicate positive serology for HCV (hepatitis C virus) and/or HBsAG (hepatitis B surface antigen). Positive serology for HBV antibodies is allowed.
  • History of other malignancies at other sites, except effectively treated non-melanoma skin cancers, superficial bladder cancer or carcinoma in situ of the cervix or an effectively treated malignancy that has been in remission for greater than 5 years and is highly likely to have been cured
  • Uncontrolled medical problems (neurological, cardiovascular, gastrointestinal, genitourinary or other illness) considered as unwarranted high risk for investigational new drug treatment
  • Patient is lactating
  • Staging classification of TX or NX or MX
  • Prior adjuvant chemotherapy within 8 weeks prior to the Day 0 visit
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00062907

Locations
United States, Florida
Cancer Centers of Florida     Recruiting
      Ocoee, Florida, United States, 34761
      Contact: Bobbi Rehm, RN     407-292-3042     brehm@usoncology.com    
      Principal Investigator: Barry S. Berman, MD            
United States, Texas
Mary Crowley Medical Research Clinic     Recruiting
      Dallas, Texas, United States, 75246
      Contact: Jennifer Edwards     214-658-1944     jedwards@mcmrc.com    
      Principal Investigator: John Nemunaitis, MD            
Tyler Cancer Center     Recruiting
      Tyler, Texas, United States, 75702
      Contact: Linda Dunklin, RN     903-579-9800     linda.dunklin@usoncology.com    
      Principal Investigator: Donald Richards, MD            
United States, Washington
Cancer Care Northwest     Recruiting
      Spokane, Washington, United States, 99218
      Contact: Rose Miller, RN, OCN     509-228-1432     rosalee.miller@usoncology.com    
      Principal Investigator: Stephen Anthony, D.O.            
Swedish Cancer Institute     Recruiting
      Seattle, Washington, United States, 98104
      Contact: Jane Arthur, RN     206-386-6921     jane.arthur@swedish.org    
      Principal Investigator: Howard West, MD            

Sponsors and Collaborators
Corixa Corporation
  More Information


Study ID Numbers:   CCL5001-01
First Received:   June 17, 2003
Last Updated:   December 5, 2006
ClinicalTrials.gov Identifier:   NCT00062907
Health Authority:   United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 30, 2008




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