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 - N/A
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
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Jakob Dupont, MD, Study Chair, Memorial Sloan Kettering Cancer Center
Verification Date
December 2009