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 Completed 18 and over Other 2005-0013 LUD2002-006, NCT00199849

Trial Description

Summary

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.

Further Study Information

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 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.

Trial Contact Information

Trial Lead Organizations/Sponsors

Ludwig Institute for Cancer Research

Padmanee Sharma, MD PhD

Principal Investigator

Nasser K Altorki, MD

Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00199849
Information obtained from ClinicalTrials.gov on May 27, 2008