Status:
COMPLETED
A Pilot Study of NY-ESO-1b Peptide Plus CpG 7909 and Montanide® ISA-51 in Patients With Cancer.
Lead Sponsor:
Ludwig Institute for Cancer Research
Conditions:
Cancer
Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This cancer vaccine research study involves the injection of the NY-ESO-1b peptide along with 2 other agents to help stimulate the immune system. Peptides are small fragments of protein. NY- ESO-1 pep...
Detailed Description
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 0.5 milliliter (mL) of Montanide® ISA-51 ...
Eligibility Criteria
Inclusion
- Histologically confirmed 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; age greater than or equal to 18.
Exclusion
- 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.
Key Trial Info
Start Date :
September 3 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 6 2006
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00199836
Start Date
September 3 2003
End Date
June 6 2006
Last Update
October 10 2022
Active Locations (1)
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1
Krankenhaus Nordwest
Frankfurt, Germany