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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Non-Small Cell Lung Cancer

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Trial Information

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


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

Inclusion 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

Type of Study:

Interventional

Study Design:

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

Authority:

United States: Food and Drug Administration

Study ID:

CCL5001-01

NCT ID:

NCT00062907

Start Date:

May 2003

Completion Date:

Related Keywords:

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

Name

Location

Swedish Cancer InstituteSeattle, Washington  98104
Tyler Cancer CenterTyler, Texas  75702
Cancer Care NorthwestSpokane, Washington  99202
Cancer Centers of FloridaOrlando, Florida  32806
Mary Crowley Medical Research ClinicDallas, Texas  75246