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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00066729
Recruitment Status : Completed
First Posted : August 7, 2003
Last Update Posted : April 26, 2011
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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

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.

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Study Type : Interventional  (Clinical Trial)
Masking: None (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
Study Start Date : May 2003
Actual Primary Completion Date : July 2006

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00066729

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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)
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Study Chair: Jakob Dupont, MD Memorial Sloan Kettering Cancer Center
Layout table for additonal information Identifier: NCT00066729    
Other Study ID Numbers: CDR0000318803
First Posted: August 7, 2003    Key Record Dates
Last Update Posted: April 26, 2011
Last Verified: December 2009
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:
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Fallopian Tube Neoplasms
Neoplasms by Site
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Fallopian Tube Diseases
Freund's Adjuvant
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs