Status:
COMPLETED
NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine
Lead Sponsor:
Ludwig Institute for Cancer Research
Collaborating Sponsors:
New York Presbyterian Hospital
M.D. Anderson Cancer Center
Conditions:
Prostate Cancer
Bladder Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
To evaluate the safety of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine given by particle-mediated epidermal delivery (PMED) in patients with tumor types known to express NY-ESO-1 or LAGE-1.
Detailed Description
NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device. The 4 microgram dosa...
Eligibility Criteria
Inclusion
- Patients were eligible for enrollment if they fulfilled all of the following criteria:
- 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.
- Advanced disease and have declined, delayed, failed or completed standard therapy.
- Full recovery from surgery.
- Expected survival of at least 6 months.
- Karnofsky performance scale ≥ 60.
- Adequate bone marrow, kidney, liver and immune functions.
- Able and willing to give valid written informed consent.
Exclusion
- Clinically significant heart disease (NYHA Class III or IV).
- Other serious illnesses, e.g., serious infections requiring antibiotics or bleeding disorders, clinically significant liver or renal insufficiency requiring treatment.
- Patients with serious intercurrent illness, requiring hospitalization.
- Known HIV, Hepatitis B or Hepatitis C positivity.
- History of autoimmune diseases (e.g. SLE, scleroderma). Vitiligo is not an exclusion criterion.
- 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.
- Evidence of skin disease (e.g. psoriasis, eczema or keloid formation) at the proposed administration site.
- Allergy to gold (including gold jewelry).
- History or evidence of chrysotherapy (gold salts).
- Chemotherapy, radiation therapy, or immunotherapy within 4 weeks prior to first dosing (6 weeks for nitrosoureas).
- Other malignancy within 3 years prior to entry into the study, except for treated non-melanoma skin cancer, cervical carcinoma in situ.
- Mental impairment, in the opinion of the investigator, that may compromise the ability to give informed consent and comply with the requirements of the study.
- Lack of availability for immunological and clinical follow-up assessments.
- Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dosing.
- Pregnancy or breastfeeding.
- Women of childbearing potential: Refusal or inability to use effective means of contraception.
Key Trial Info
Start Date :
September 27 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00199849
Start Date
September 27 2004
End Date
September 1 2007
Last Update
October 10 2022
Active Locations (2)
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1
New York Presbyterian Hospital
New York, New York, United States, 10021
2
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030