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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.

Phase 1
18 Years
Not Enrolling
Cancer, Neoplasm

Thank you

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

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:


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


United States: Food and Drug Administration

Study ID:




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