Safety and Immunogenicity of Recombinant DNA and Adenovirus Expressing L523S Protein in Early Stage Non-Small Cell Lung Cancer
NCT ID: NCT00062907
Last Updated: 2006-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
9 participants
INTERVENTIONAL
2003-05-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Recombinant DNA- pVAX/L523S
Recombinant adenovirus- Ad/L523S
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Corixa Corporation
INDUSTRY
Locations
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Cancer Centers of Florida
Ocoee, Florida, United States
Mary Crowley Medical Research Clinic
Dallas, Texas, United States
Tyler Cancer Center
Tyler, Texas, United States
Swedish Cancer Institute
Seattle, Washington, United States
Cancer Care Northwest
Spokane, Washington, United States
Countries
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Facility Contacts
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Bobbi Rehm, RN
Role: primary
Jennifer Edwards
Role: primary
Linda Dunklin, RN
Role: primary
Jane Arthur, RN
Role: primary
Rose Miller, RN, OCN
Role: primary
Other Identifiers
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CCL5001-01
Identifier Type: -
Identifier Source: org_study_id