Phase I Study of ALVAC(2)-NY-ESO-1(M)/TRICOM in Patients With Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma Whose Tumors Express NY-ESO-1 or LAGE-1 Antigen
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal
cavity cancer
- Stage II-IV disease
- Tumor expresses 1 of the following antigens:
- NY-ESO-1 by RT-PCR or IHC
- LAGE-1 by RT-PCR
- Previously treated with initial surgery AND ≥ 1 platinum-based chemotherapy regimen
- Must have demonstrated complete response to prior front-line therapy as evidenced by
negative clinical examination, no objective evidence of disease progression by CT
scan, and serum CA-125 ≤ 35 IU/mL
- If second-look surgery was performed, patient may have either a negative or
microscopic positive second-look surgery (laparoscopy or laparotomy)
- Recurrent disease allowed provided patient completed surgery and/or chemotherapy for
recurrent disease
- Patient may have asymptomatic residual measurable disease by physical
examination and/or CT scan and/or elevated CA-125 or may be in complete clinical
remission
- No CNS metastases
PATIENT CHARACTERISTICS:
- Karnofsky performance status ≥ 70%
- Life expectancy ≥ 6 months
- ANC ≥ 1,500/mm^3
- WBC ≥ 5,000/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 10 g/dL
- Serum creatinine ≤ 2 mg/dL
- Serum bilirubin ≤ 2 mg/dL
- No history of autoimmune disease (e.g., thyroiditis or lupus), except vitiligo
- No known immunodeficiency or HIV positivity
- No known allergy or history of life threatening reaction to sargramostim (GM-CSF)
- No known history of allergies to eggs, neomycin, or bovine products
- No history of severe allergic reactions to vaccines or unknown allergens
- None of the following cardiovascular conditions:
- Myocardial infarction
- Angina
- Congestive heart failure
- Cardiomyopathy
- Stroke or transient ischemic attack
- Chest pain or shortness of breath with activity
- Other heart conditions being treated by a doctor
- No other serious illness (e.g., serious infections requiring antibiotics or bleeding
disorders)
- No other malignancy within the past 3 years, except previously treated nonmelanoma
skin cancer or carcinoma in situ of the cervix
- No mental impairment that may compromise the ability to give informed consent and
comply with study requirements
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from prior surgery
- More than 4 weeks since prior and no concurrent chemotherapy (6 weeks for
nitrosoureas), radiotherapy, immunotherapy, or other anticancer therapy
- Concurrent hormonal or hormonal-related anticancer therapy allowed
- More than 4 weeks since prior participation in another clinical trial involving an
investigational agent
- No prior NY-ESO-1 vaccine therapy
- No concurrent systemic corticosteroids, antihistamines, non-steroidal
anti-inflammatory drugs, or other immunosuppressants
- Concurrent low-dose aspirin (≤ 100 mg/day) or specific COX-2 inhibitors allowed