Recruiting
Phase 1

Recombinant DNA & Adenovirus

Sponsor:

Corixa Corporation

Code:

NCT00062907

Conditions

Non-Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Recombinant DNA- pVAX/L523S

Recombinant adenovirus- Ad/L523S

Study Details

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.

Conditions

Non-Small Cell Lung Cancer

Study ID

NCT00062907

Start date

May, 2003

Status verified date

Nov, 2004

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

9 participants

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Recombinant DNA- pVAX/L523S

Recombinant adenovirus- Ad/L523S

Central Contacts and Locations

Locations

Cancer Centers of Florida

Recruiting

Ocoee, Florida, United States, 34761

Contacts

Bobbi Rehm, RN

407-292-3042brehm@usoncology.com

Principal Investigator:

Barry S. Berman, MD

Mary Crowley Medical Research Clinic

Recruiting

Dallas, Texas, United States, 75246

Contacts

Jennifer Edwards

214-658-1944jedwards@mcmrc.com

Principal Investigator:

John Nemunaitis, MD

Tyler Cancer Center

Recruiting

Tyler, Texas, United States, 75702

Contacts

Linda Dunklin, RN

903-579-9800linda.dunklin@usoncology.com

Principal Investigator:

Donald Richards, MD

Swedish Cancer Institute

Recruiting

Seattle, Washington, United States, 98104

Contacts

Jane Arthur, RN

206-386-6921jane.arthur@swedish.org

Principal Investigator:

Howard West, MD

Cancer Care Northwest

Recruiting

Spokane, Washington, United States, 99218

Contacts

Rose Miller, RN, OCN

509-228-1432rosalee.miller@usoncology.com

Principal Investigator:

Stephen Anthony, D.O.

More Information

Sponsor

Corixa Corporation

Last update posted

Dec 6, 2006

Last verified

Nov, 2004

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Corixa Corporation on 2006-12-06.