Status:
COMPLETED
NY-ESO-1 Protein With Montanide and CpG 7909 as Cancer Vaccine in Several Tumors
Lead Sponsor:
Ludwig Institute for Cancer Research
Collaborating Sponsors:
NYU Langone Health
Conditions:
Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a Phase I, open-label, randomized study of NY-ESO-l protein with immune adjuvants CpG 7909 and Montanide ISA-51 VG in patients with tumors that often express NY-ESO-1. The vaccinations was to...
Detailed Description
Subjects were to receive an investigational (research) cancer vaccine every 3 weeks for a total of 4 treatments. It was given by injection underneath the skin in an extremity (leg or arm). A vaccine i...
Eligibility Criteria
Inclusion
- Histological diagnosis of hepatocellular carcinoma, bladder cancer, breast cancer, non-small lung cancer (NSCLC), melanoma, sarcoma, prostate cancer, esophageal cancer, or ovarian cancer, independent of NY-ESO-1 expression in a tumor biopsy.
- or
- Histological diagnosis of other types of cancers, provided NY-ESO-1 or LAGE-1 expression can be shown in a tumor biopsy.
- At least 4 weeks since surgery prior to first dosing of study agent.
- Laboratory values within the following limits:
- Hemoglobin ≥ 11.0 g/dL
- Neutrophil count ≥ 1.5 x l0\^9/L
- Lymphocyte count ≥ lower limit of institutional normal
- Platelet count ≥ 80 x l0\^9/L
- Serum creatinine ≤ 2.0 mg/dL
- Serum bilirubin ≤ 2 x upper limit of institutional normal
- AST/ALT ≤ 2 x upper limit of institutional normal
- Patients must have a Karnofsky performance status of ≥70%.
- Life expectancy ≥ 6 months.
- Age ≥ 18 years.
- Able and willing to give witnessed, written informed consent for participation in the trial.
Exclusion
- Clinically significant heart disease (i.e. NYHA class 3 congestive heart failure; myocardial infarction within the past six months; unstable angina; coronary angioplasty within the past 6 months; uncontrolled atrial or ventricular cardiac arrhythmias).
- Other serious illnesses, eg, serious infections requiring antibiotics, bleeding disorders.
- Previous bone marrow or stem cell transplant.
- History of immunodeficiency disease or autoimmune disease except vitiligo.
- Metastatic disease to the central nervous system, unless treated and stable.
- Other malignancy within 3 years prior to entry into the study, except for treated early-stage melanoma or non-melanoma skin cancer, or cervical carcinoma in situ.
- Known HIV, Hepatitis B or Hepatitis C positivity.
- Chemotherapy, radiation therapy or immunotherapy within 4 weeks prior to first dose of study agent (6 weeks for nitrosoureas).
- Concomitant treatment with steroids. Topical or inhalational steroids are permitted.
- Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dose of study agent.
- Pregnancy or lactation.
- Women of childbearing potential not using a medically acceptable means of contraception.
- Psychiatric or addictive disorders that may compromise the ability to give informed consent.
- Lack of availability of the patient for immunological and clinical follow-up assessment.
Key Trial Info
Start Date :
March 21 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 10 2014
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00299728
Start Date
March 21 2006
End Date
January 10 2014
Last Update
October 10 2022
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
NYU Clinical Cancer Center
New York, New York, United States, 10016
2
NY Presbyterian- Columbia
New York, New York, United States, 10032