A Pilot Study of NY-ESO-1b Peptide Plus CpG 7909 and Montanide ISA-51 in Patients With Cancer Expressing NY-ESO-1 or LAGE-1.
18 Years
N/A
Both
Cancer, Neoplasm
Trial Information
A Pilot Study of NY-ESO-1b Peptide Plus CpG 7909 and Montanide ISA-51 in Patients With Cancer Expressing NY-ESO-1 or LAGE-1.
This is a pilot study of patients of HLA-A2 phenotype whose tumor expresses the NY-ESO-1 or
LAGE-1 antigen. Patients will receive NY-ESO-1b peptide mixed with 0.5mL of Montanide ISA-51
and 1mg of CpG7909 given every three weeks for four doses by subcutaneous injection. There
will be a three-week follow-up period after the fourth injection making the cycle 13 weeks
long. In the absence of toxicity and progressive disease, a second cycle will be offered to
patients who have received four vaccinations.
The primary objective is to evaluate the immune response (antibodies, CD8+ T cells, and DTH)
and safety to vaccination with NY-ESO-1b peptide mixed with CpG 7909 and Montanide in
patients with cancer expressing NY-ESO-1 or LAGE-1. The secondary objective is to document
tumor responses in patients with evaluable or measurable disease.
Inclusion Criteria:
- Metastatic, measurable cancer or resected high risk Stage III/IV;resected Stage II,
III, or IV non small cell lung cancer or esophageal cancer who have declined, failed,
or completed standard therapy; tumor expression of NY-ESO-1 or LAGE-1 antigen; HLA-A2
positive; karnofsky performance status greater than or equal to 60 %; hematology and
biochemistry laboratory results within the limits normally expected for the patient
population.
Exclusion Criteria:
- Clinically significant heart disease; other serious illnesses; patients with serious
intercurrent illness, requiring hospitalization; patients taking immunosuppressive
drugs; autoimmune disease; known HIV positivity; other active malignancy within 1
year prior to entry into the study; participation in chemotherapy, radiation therapy,
or any other clinical trial involving another investigational agent within 4 weeks
prior to enrollment; pregnancy or breastfeeding; 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/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
NY-ESO-1 specific humoral immunity
Principal Investigator
Nasser K Altorki, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Weill Medical College of Cornell University
Authority:
United States: Food and Drug Administration
Study ID:
LUD2002-007
NCT ID:
NCT00199836
Start Date:
September 2003
Completion Date:
December 2005
Related Keywords:
- Cancer
- Neoplasm
- cancer vaccine
- NY-ESO-1b peptide
- CpG 7909
- Montanide ISA-51
- LAGE-1
- immune response
- safety
- Neoplasms
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