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Trial record 3 of 14 for:    NY-ESO-1/LAGE-1

A Pilot Study of NY-ESO-1b Peptide Plus CpG 7909 and Montanide ISA-51 in Patients With Cancer.

This study has been completed.
Sponsor:
Information provided by:
Ludwig Institute for Cancer Research
ClinicalTrials.gov Identifier:
NCT00199836
First received: September 12, 2005
Last updated: August 21, 2006
Last verified: August 2006
  Purpose
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 every protein. These 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

Condition Intervention Phase
Cancer
Neoplasm
Biological: NY-ESO-1b peptide plus CpG 7909 and Montanide ISA-51
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Ludwig Institute for Cancer Research:

Primary Outcome Measures:
  • NY-ESO-1 specific humoral immunity
  • NY-ESO-1 specific cellular immunity
  • DTH to NY-ESO-1b peptide
  • Toxicities and adverse events

Secondary Outcome Measures:
  • Tumor response

Estimated Enrollment: 9
Study Start Date: September 2003
Estimated Study Completion Date: December 2005
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 0.5mL 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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00199836

Locations
Germany
Krankenhaus Nordwest
Frankfurt, Germany
Sponsors and Collaborators
Ludwig Institute for Cancer Research
Investigators
Principal Investigator: Nasser K Altorki, MD Weill Medical College of Cornell University
  More Information

ClinicalTrials.gov Identifier: NCT00199836     History of Changes
Other Study ID Numbers: LUD2002-007 
Study First Received: September 12, 2005
Last Updated: August 21, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Ludwig Institute for Cancer Research:
cancer vaccine
NY-ESO-1b peptide
CpG 7909
Montanide ISA-51
LAGE-1
immune response
safety

Additional relevant MeSH terms:
Freund's Adjuvant
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 29, 2016