Clinical trial NCT00199836: A Pilot Study of NY-ESO-1b Peptide Plus CpG 7909 and Montanide® ISA-51 in Patients With Cancer.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Neoplasm
Keywords: cancer vaccine
NY-ESO-1b peptide
CpG 7909
Montanide® ISA-51
LAGE-1
immune response
safety
Lead sponsor: Ludwig Institute for Cancer Research
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 peptides are normally found in the testis and the placenta. They have also been found on various types of cancer cells. The purpose is to stimulate the immune system to react against the peptides that are found on cancer cells.

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 and 1 mg of CpG 7909 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.

Eligibility criteria: Inclusion Criteria:

* 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 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.

Primary outcomes:
measure: Number of Patients With NY-ESO-1 Specific Humoral Immunity as Determined by an Increase in Antibody Titer From Baseline.
timeFrame: up to 27 weeks
measure: Number of Patients With NY-ESO-1 Specific Cellular Immunity as Measured by an Increase in NY-ESO-1b Specific CD8+ T-cells Following Treatment.
timeFrame: up to 27 weeks
measure: Number of Patients With Delayed-Type Hypersensitivity (DTH) Skin Reactions to NY-ESO-1b Peptide
timeFrame: up to 25 weeks
measure: Safety as Measured by the Number of Patients With Dose Limiting Toxicities (DLT)
timeFrame: up to 28 weeks
Secondary outcomes:
measure: Number of Patients With Tumor Responses as Measured by the Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: up to 28 weeks
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Krankenhaus Nordwest
Study officials:
affiliation: Weill Medical College of Cornell University
name: Nasser K Altorki, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000 Feb 2;92(3):205-16. doi: 10.1093/jnci/92.3.205.
citation: Karbach J, Gnjatic S, Bender A, Neumann A, Weidmann E, Yuan J, Ferrara CA, Hoffmann E, Old LJ, Altorki NK, Jager E. Tumor-reactive CD8+ T-cell responses after vaccination with NY-ESO-1 peptide, CpG 7909 and Montanide ISA-51: association with survival. Int J Cancer. 2010 Feb 15;126(4):909-18. doi: 10.1002/ijc.24850.