Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Active 18 and over Pharmaceutical / Industry CCL5001-01 NCT00062907

Trial Description

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.

Further Study Information

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Corixa

U.S.A.
Florida
	Ocoee
	Cancer Centers of Florida - Ocoee
		Bobbi Rehm, RN	Ph: 407-292-3042
			Email: brehm@usoncology.com
		Barry S. Berman	Principal Investigator
Texas
	Dallas
	Mary Crowley Medical Research Center at Sammons Cancer Center
		Jennifer Edwards	Ph: 214-658-1944
			Email: jedwards@mcmrc.com
		John J. Nemunaitis	Principal Investigator
	Tyler
	Tyler Cancer Center
		Linda Dunklin, RN	Ph: 903-579-9800
			Email: linda.dunklin@usoncology.com
		Donald A. Richards	Principal Investigator
Washington
	Seattle
	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
		Jane Arthur, RN	Ph: 206-386-6921
			Email: jane.arthur@swedish.org
		Howard West, MD	Principal Investigator
	Spokane
	Cancer Care Northwest - North
		Rose Miller, RN, OCN	Ph: 509-228-1432
			Email: rosalee.miller@usoncology.com
		Stephen Anthony, D.O.	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00062907
Information obtained from ClinicalTrials.gov on May 27, 2008