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

Non-Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00062907
• Other study ID #: CCL5001-01
• Status: Recruiting
• Phase: Phase 1
• First received: June 17, 2003
• Last updated: December 5, 2006
• Start date: May 2003

Study information

• Verified date: November 2004
• Source: Corixa Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 9
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Biological:
• Recombinant DNA- pVAX/L523S

• Recombinant adenovirus- Ad/L523S

Locations

Country	Name	City	State
United States	Mary Crowley Medical Research Clinic	Dallas	Texas
United States	Cancer Centers of Florida	Ocoee	Florida
United States	Swedish Cancer Institute	Seattle	Washington
United States	Cancer Care Northwest	Spokane	Washington
United States	Tyler Cancer Center	Tyler	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Corixa Corporation

Country where clinical trial is conducted

United States,