Clinical trial NCT00062907: Safety and Immunogenicity of Recombinant DNA and Adenovirus Expressing L523S Protein in Early Stage Non-Small Cell Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Corixa Corporation
Sponsor class: INDUSTRY
First posted: 2003-06-19
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ocoee
country: United States
facility: Cancer Centers of Florida
state: Florida
city: Dallas
country: United States
facility: Mary Crowley Medical Research Clinic
state: Texas
city: Tyler
country: United States
facility: Tyler Cancer Center
state: Texas
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Spokane
country: United States
facility: Cancer Care Northwest
state: Washington
Study officials:
References: