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Vaccine Therapy in Treating Patients With Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
This study is ongoing, but not recruiting participants.
Study NCT00066729   Information provided by National Cancer Institute (NCI)
First Received: August 6, 2003   Last Updated: February 6, 2009   History of Changes

August 6, 2003
February 6, 2009
May 2003
 
 
 
Complete list of historical versions of study NCT00066729 on ClinicalTrials.gov Archive Site
 
 
 
Vaccine Therapy in Treating Patients With Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
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

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.

OBJECTIVES:

  • 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.

Phase I
Interventional
Treatment, Open Label
  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Peritoneal Cavity Cancer
  • Biological: NY-ESO-1 peptide vaccine
  • Biological: incomplete Freund's adjuvant
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Karnofsky 60-100%

Life expectancy

  • At least 6 months

Hematopoietic

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

Hepatic

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

Renal

  • Creatinine no greater than 1.5 mg/dL

Cardiovascular

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

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • See Disease Characteristics
  • No concurrent chemotherapy

Endocrine therapy

  • Concurrent tamoxifen is allowed
  • No concurrent systemic corticosteroids

Radiotherapy

  • Not specified

Surgery

  • See Disease Characteristics

Other

  • 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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00066729
 
CDR0000318803, MSKCC-03034, LUDWIG-LUD2002-014
Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Jakob Dupont, MD Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
April 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP