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

Brief Title

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

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

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.

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.

Study Phase

Phase 1

Study Type

Interventional

Condition

Fallopian Tube Cancer

Intervention

NY-ESO-1 peptide vaccine

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Biological

Start Date

May 2003

Primary Completion Date

July 2006

Eligibility 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

Gender

Female

Ages

18 Years - 120 Years

Accepts Healthy Volunteers

No

Contacts

Jakob Dupont, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT00066729

Organization ID

CDR0000318803

Secondary IDs

MSKCC-03034

Study Sponsor

Ludwig Institute for Cancer Research

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Jakob Dupont, MD, Study Chair, Memorial Sloan Kettering Cancer Center

Verification Date

February 2021