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Safety and Immunological Evaluation of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine Given by Particle-Mediated Epidermal Delivery (PMED) in Patients With Tumor Type Known to Express NY-ESO-1 or LAGE-1 Antigen.


Phase 1
18 Years
N/A
Not Enrolling
Both
Prostate Cancer, Bladder Cancer, Non-Small Cell Lung Cancer, Esophageal Cancer, Sarcoma

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Trial Information

Safety and Immunological Evaluation of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine Given by Particle-Mediated Epidermal Delivery (PMED) in Patients With Tumor Type Known to Express NY-ESO-1 or LAGE-1 Antigen.


Eligible patients with tumor type known to express NY-ESO-1 or LAGE-1 antigen will be
assigned to cohorts. NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine will be administered by
PMED at a pressure of 500 psi using the XR-1 Powderject delivery device. The 4 microgram
dosage of NY-ESO-1 will be administered as 4 X 1 microgram PMEDs in close proximity.
Similarly, the 8 microgram dosage will be administered as 8 X 1 microgram PMEDs. The third
cohort of patients will receive the 8 microgram dosage as a cluster dosage of 4 doses (day
1, 3, 5, 8) as 2 X 1 microgram PMEDs per day.

Blood samples will be obtained at baseline, 2 weeks after each vaccination, prior to the
second and third vaccination, and 4 weeks after the third vaccination for the assessment of
clinical hematology, biochemistry measurements and immunology responses. Patients will be
evaluated for toxicity throughout the study.

DTH testing will be performed with NY-ESO-1 protein in all patients, with NY-ESO-1b peptide
in HLA-A2+ patients and with NY-ESO-1 DP4 peptide in HLA-DP4+ patients at baseline and at
the 2-week visit following the first and third vaccinations.

NY-ESO-1 and/or LAGE-1 specific antibodies will be assessed in all patients by ELISA using
recombinant NY-ESO-1 protein. NY-ESO-1 specific CD4+ and CD8+ T cells will be assessed in
all patients by tetramer and/or ELISPOT assays.

Disease status will be assessed at baseline and 4 weeks after the third vaccination in
patients with measurable disease.


Inclusion Criteria:



Patients will be eligible for enrollment if they fulfill all of the following criteria:

1. Histologically proven tumor type known to express NY-ESO-1 or LAGE-1 (prostate
cancer, breast cancer, bladder cancer, hepatocellular cancer, synovial sarcoma,
leiomyosarcoma, head and neck, lung cancer, esophageal, ovarian, neuroblastoma); or
NY-ESO-1 or LAGE-1 positive tumors determined by reverse transcriptase and polymerase
chain reaction (RT-PCR) analysis, preferably, or immunohistochemistry or expression
of LAGE-1 by RT-PCR.

2. Advanced disease and have declined, delayed, failed or completed standard therapy.

3. Full recovery from surgery.

4. Expected survival of at least 6 months.

5. Karnofsky performance scale >60.

6. Adequate bone marrow, kidney, liver and immune functions.

Exclusion Criteria:

1. Clinically significant heart disease (NYHA Class III or IV).

2. Other serious illnesses, e.g., serious infections requiring antibiotics or bleeding
disorders, clinically significant liver or renal insufficiency requiring treatment.

3. Patients with serious intercurrent illness, requiring hospitalization.

4. Known HIV, Hepatitis B or Hepatitis C positivity.

5. History of autoimmune diseases (e.g. SLE, scleroderma). Vitiligo is not an exclusion
criterion.

6. Concomitant systemic treatment with corticosteroids, anti-histaminic drugs or
non-steroidal anti-inflammatory drugs. Specific COX-2 inhibitors are permitted. Low
dose aspirin is permitted. Topical or inhalational steroids are permitted.

7. Evidence of skin disease (e.g. psoriasis, eczema or keloid formation) at the proposed
administration site.

8. Allergy to gold (including gold jewelry).

9. History or evidence of chrysotherapy (gold salts).

10. Chemotherapy, radiation therapy, or immunotherapy within 4 weeks prior to first
dosing (6 weeks for nitrosoureas).

11. Other malignancy within 3 years prior to entry into the study, except for treated
non-melanoma skin cancer, cervical carcinoma in situ and incidental prostate cancer
on radical cystoprostatectomy specimen.

12. Mental impairment, in the opinion of the investigator, may compromise the ability to
give informed consent and comply with the requirements of the study.

13. Lack of availability for immunological and clinical follow-up assessments.

14. Participation in any other clinical trial involving another investigational agent
within 4 weeks prior to first dosing.

15. Pregnancy or breastfeeding.

16. Women of childbearing potential: Refusal or inability to use effective means of
contraception.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

estimate the safety of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine given by PMED in patients with tumor type known to express NY-ESO-1 or LAGE-1 using frequency, severity, and duration of treatment-related adverse effects as endpoints.

Principal Investigator

Padmanee Sharma, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center Genitourinary Med Onc

Authority:

United States: Food and Drug Administration

Study ID:

2005-0013

NCT ID:

NCT00199849

Start Date:

May 2004

Completion Date:

May 2007

Related Keywords:

  • Prostate Cancer
  • Bladder Cancer
  • Non-Small Cell Lung Cancer
  • Esophageal Cancer
  • Sarcoma
  • NY-ESO-1
  • DNA
  • Urinary Bladder Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Lung Neoplasms
  • Prostatic Neoplasms
  • Sarcoma

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030
New York Presbyterian HospitalNew York, New York  10021