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

History of Changes

Tracking Information
First Received Date ^ICMJE	June 17, 2003
Last Updated Date	December 5, 2006
Start Date ^ICMJE	May 2003
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00062907 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety and Immunogenicity of Recombinant DNA and Adenovirus Expressing L523S Protein in Early Stage Non-Small Cell Lung Cancer
Official Title ^ICMJE	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
Brief Summary	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.
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
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Non-Small Cell Lung Cancer
Intervention ^ICMJE	Biological: Recombinant DNA- pVAX/L523S Biological: Recombinant adenovirus- Ad/L523S
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Enrollment ^ICMJE	9
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00062907
Other Study ID Numbers ^ICMJE	CCL5001-01
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Corixa Corporation
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Corixa Corporation
Verification Date	November 2004
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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