Sirolimus and Vaccine Therapy in Treating Patients With Stage II-IV Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer

This is an interventional treatment trial for Recurrent Fallopian Tube Cancer Read More

Inclusion Criteria:

• Eligible patients will be women with stages II-IV epithelial ovarian, fallopian tube, or primary peritoneal carcinoma who have completed standard therapy for primary or recurrent disease (i.e., patients who would normally be observed); eligible patients may have asymptomatic residual measurable disease on physical examination and/or computed tomography (CT) scan, and/or may have an elevated cancer antigen 125 (CA-125); or may be in complete clinical remission after treatment for primary or recurrent disease; these patients would normally enter a period of observation after standard management
• Any human leukocyte antigen (HLA) type; (historic HLA typing is permitted)
• Tumor expression of NY-ESO-1 or cancer/testis antigen 2 (LAGE-1) by immunohistochemistry (IHC) and/or real-time polymerase chain reaction (RT-PCR)
• No allergy to eggs
• Life expectancy > 6 months
• Hematology and biochemistry laboratory results within the limits normally expected for the patient population, without evidence of major organ failure
• Absolute neutrophil count (ANC) >= 1,000/uL
• Platelet >= 75,000/uL
• Hemoglobin (Hgb) >= 8 g/dL
• Total bilirubin =< 1.5 x upper limit of normal (ULN)
• Serum glutamic oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST) or serum glutamic pyruvic transaminase (SGPT)/alanine aminotransferase (ALT) =< 3 x ULN
• Serum creatinine =< 2 x ULN
• Prothrombin time (PT)/international normalized ratio (INR) =< 1.5
• Electrocardiogram, showing no evidence of congestive heart failure, myocardial infarction, and cardiomyopathy
• Have been informed of other treatment options
• Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
• Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of =< 2
• Demonstrate the ability to swallow and retain oral medication
• Patients of child-bearing potential must agree to use acceptable contraceptive methods (e.g., double barrier) during treatment
• Patients may have received previous NY-ESO-1 vaccine therapy

Exclusion Criteria:

• Metastatic disease to the central nervous system for which other therapeutic options, including radiotherapy, may be available
• Other serious illnesses (e.g. serious infections requiring antibiotics, bleeding disorders)
• History of severe autoimmune disorders requiring use of steroids or other immunosuppressives
• Concomitant systemic treatment with corticosteroids, anti-histamine or nonsteroidal anti-inflammatory drugs and other platelet inhibitory agents, strong inhibitors/inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP450-3A4)
• Chemotherapy, radiation therapy, or immunotherapy within 4 weeks prior to first dosing of study drug (6 weeks for nitrosoureas); concomitant hormonal therapies for breast cancers are allowed
• Known allergy or history of life threatening reaction to GM-CSF
• Clinically significant heart disease (N-YHA Class III or IV)
• Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dosing of study drug
• Known hepatitis B, hepatitis C, or HIV
• Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study
• Lack of availability of a patient for immunological and clinical follow-up assessment
• Known pulmonary hypertension
• Known hypersensitivity to sirolimus
• Evidence of current drug or alcohol abuse or psychiatric impairment, which in the investigator's opinion will prevent completion of the protocol therapy or follow-up
• Pregnant or nursing female patients
• Unwilling or unable to follow protocol requirements
• Any condition which in the investigator's opinion deems the patient an unsuitable candidate to receive study drug; (i.e., any significant medical illness or abnormal laboratory finding that would, in the investigator's judgment, increase the subject's risk by participating in this study)