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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00066729
First received: August 6, 2003
Last updated: April 23, 2011
Last verified: December 2009
  Purpose

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:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00066729

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Jakob Dupont, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00066729     History of Changes
Other Study ID Numbers: CDR0000318803, MSKCC-03034, LUDWIG-LUD2002-014
Study First Received: August 6, 2003
Last Updated: April 23, 2011
Health Authority: United States: Federal Government

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:
Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases
Freund's Adjuvant
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014