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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2004 by Corixa Corporation.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Corixa Corporation
ClinicalTrials.gov Identifier:
NCT00062907
First received: June 17, 2003
Last updated: December 5, 2006
Last verified: November 2004
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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
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: 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
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         
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.         
Sponsors and Collaborators
Corixa Corporation
  More Information

No publications provided

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

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

ClinicalTrials.gov processed this record on September 14, 2014