Trial record 3 of 14 for:    NY-ESO-1/LAGE-1

NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine

This study has been completed.
Sponsor:
Collaborators:
New York Presbyterian Hospital
M.D. Anderson Cancer Center
Memorial Sloan-Kettering Cancer Center
Information provided by:
Ludwig Institute for Cancer Research
ClinicalTrials.gov Identifier:
NCT00199849
First received: September 12, 2005
Last updated: August 21, 2007
Last verified: August 2007
  Purpose

To 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.


Condition Intervention Phase
Prostate Cancer
Bladder Cancer
Non-Small Cell Lung Cancer
Esophageal Cancer
Sarcoma
Biological: NY-ESO-1 plasmid DNA Cancer Vaccine
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Ludwig Institute for Cancer Research:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • evaluate NY-ESO-1 specific cellular and humoral immunity by determination of: a)NY-ESO-1 specific antibody, NY-ESO-1 specific CD8+ and CD4+ cells and b) delayed-type-hypersensitivity [DTH]) induced by NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine
  • document tumor response

Estimated Enrollment: 15
Study Start Date: May 2004
Study Completion Date: May 2007
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00199849

Locations
United States, New York
New York Presbyterian Hospital
New York, New York, United States, 10021
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Ludwig Institute for Cancer Research
New York Presbyterian Hospital
M.D. Anderson Cancer Center
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Padmanee Sharma, MD PhD UT MD Anderson Cancer Center Genitourinary Med Onc
Principal Investigator: Nasser K Altorki, MD Weill Medical College of Cornell University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00199849     History of Changes
Other Study ID Numbers: 2005-0013, LUD2002-006
Study First Received: September 12, 2005
Last Updated: August 21, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Ludwig Institute for Cancer Research:
NY-ESO-1
DNA

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Carcinoma, Non-Small-Cell Lung
Esophageal Neoplasms
Lung Neoplasms
Prostatic Neoplasms
Sarcoma
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Genital Neoplasms, Male
Genital Diseases, Male
Prostatic Diseases
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on August 25, 2014