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Vaccine Therapy in Treating Patients With Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

This study has been completed.
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: August 6, 2003
Last updated: April 23, 2011
Last verified: December 2009

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

PURPOSE: This phase I trial to studying the side effects of vaccine therapy in treating patients with ovarian epithelial, primary peritoneal, or fallopian tube cancer.

Condition Intervention Phase
Fallopian Tube Cancer
Ovarian Cancer
Primary Peritoneal Cavity Cancer
Biological: NY-ESO-1 peptide vaccine
Biological: incomplete Freund's adjuvant
Phase 1

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study Of NY-ESO-1b Peptide Plus Montanide ISA-51 In Patients With Ovarian, Primary Peritoneal, Or Fallopian Tube Cancer Expressing NY-ESO-1 or LAGE-1

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: May 2003
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Detailed Description:


  • Determine the safety of NY-ESO-1b peptide vaccine and Montanide ISA-51 in patients with ovarian epithelial, primary peritoneal, or fallopian tube cancer expressing NY-ESO-1 or LAGE-1.
  • Determine the immunologic profile (NY-ESO-1 antibody, CD8+ cells, and delayed-type hypersensitivity) induced by this regimen in these patients.

OUTLINE: This is an open-label study.

Patients receive NY-ESO-1b peptide vaccine emulsified with Montanide ISA-51 subcutaneously once every 3 weeks on weeks 1, 4, 7, 10, and 13 in the absence of disease progression or unacceptable toxicity.

Patients are followed at 3 weeks and then every 6-12 weeks for 2 years or until disease progression.

PROJECTED ACCRUAL: A total of 9 patients will be accrued for this study.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Histologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer

    • Stage II-IV at diagnosis
  • Previously treated with cytoreductive surgery and at least 1 platinum-based chemotherapy regimen
  • High-risk feature, defined as 1 of the following:

    • Suboptimal primary debulking (remaining tumor masses with diameter at least 1.0 cm)
    • Failure to normalize CA 125 during primary therapy by the end of the third course
  • Complete clinical remission, defined as all of the following:

    • CA 125 less than 35 units
    • Negative physical examination
    • No definite evidence of disease by CT scan of the abdomen and pelvis* NOTE: *Lymph nodes and/or soft tissue abnormalities in the pelvis, no greater than 1.0 cm, are not considered definite evidence of disease
  • HLA-A2 positive
  • Tumor expression of 1 of the following proteins:

    • NY-ESO-1 by reverse transcriptase and polymerase chain reaction (RT-PCR) analysis or immunohistochemistry
    • LAGE-1 by RT-PCR
  • No more than 4 months since prior primary therapy
  • No CNS metastases



  • 18 and over

Performance status

  • Karnofsky 60-100%

Life expectancy

  • At least 6 months


  • Absolute neutrophil count at least 1,000/mm^3
  • Platelet count at least 80,000/mm^3
  • No bleeding disorders


  • Bilirubin less than 2.5 times upper limit of normal (ULN)
  • ALT and AST less than 2.5 times ULN


  • Creatinine no greater than 1.5 mg/dL


  • No New York Heart Association class III or IV heart disease


  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • HIV negative
  • No serious infections requiring antibiotics
  • No serious concurrent illness requiring hospitalization
  • No other malignancy within the past 3 years except treated nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No mental impairment that would preclude giving informed consent or complying with study requirements


Biologic therapy

  • Not specified


  • See Disease Characteristics
  • No concurrent chemotherapy

Endocrine therapy

  • Concurrent tamoxifen is allowed
  • No concurrent systemic corticosteroids


  • Not specified


  • See Disease Characteristics


  • More than 4 weeks since prior participation in any other investigational study
  • Concurrent non-cytotoxic anticancer therapy allowed
  • No concurrent immunosuppressive drugs
  • No concurrent nonsteroidal anti-inflammatory drugs except as low dose for the prevention of acute cardiovascular events or for pain control
  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 identifier: NCT00066729

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Jakob Dupont, MD Memorial Sloan Kettering Cancer Center
  More Information Identifier: NCT00066729     History of Changes
Other Study ID Numbers: CDR0000318803
Study First Received: August 6, 2003
Last Updated: April 23, 2011

Keywords provided by National Cancer Institute (NCI):
stage II ovarian epithelial cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
primary peritoneal cavity cancer
fallopian tube cancer

Additional relevant MeSH terms:
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Fallopian Tube Diseases
Adnexal Diseases
Genital Diseases, Female
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Freund's Adjuvant
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic processed this record on April 25, 2017