Safety and Immunogenicity of Recombinant DNA and Adenovirus Expressing L523S Protein in Early Stage Non-Small Cell Lung Cancer
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
1 other identifier
interventional
9
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 nonsmall-cell-lung-cancer
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2003
CompletedFirst Submitted
Initial submission to the registry
June 17, 2003
CompletedFirst Posted
Study publicly available on registry
June 19, 2003
CompletedDecember 6, 2006
November 1, 2004
June 17, 2003
December 5, 2006
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Cancer Centers of Florida
Ocoee, Florida, 34761, United States
Mary Crowley Medical Research Clinic
Dallas, Texas, 75246, United States
Tyler Cancer Center
Tyler, Texas, 75702, United States
Swedish Cancer Institute
Seattle, Washington, 98104, United States
Cancer Care Northwest
Spokane, Washington, 99218, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 17, 2003
First Posted
June 19, 2003
Study Start
May 1, 2003
Last Updated
December 6, 2006
Record last verified: 2004-11