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
Inclusion 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