Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomised,Double Blind, Placebo Controlled, Multicentre Trial of Abagovomab Maintenance Therapy in Patients With Epithelial Ovarian Cancer After Complete Response to First Line Chemotherapy
Brief Summary: The purpose of this study is to evaluate the benefit of vaccination with Abagovomab, an experimental immunotherapy in ovarian cancer patients. The benefit will be evaluated in terms of time the remission status is kept as well as prolongation of life expectancy.


Options:
A: Inclusion Criteria:

* histological confirmed diagnosis cancer
* symptomatic malignant ascites
* EpCAM positive tumor
* EOCG 0-2
* negative pregnancy

Exclusion Criteria:

* acute or chronic infection
* exposure to investigational product, cancer chemo- or radiotherapy within the last 28 days
* previous treatment with mouse monoclonal antibodies
* known or suspected hypersensitivity to Removab or similar antibodies
* inadequate renal function
* inadequate hepatic function (AST, ALt, GTP,\< x ULN; bilirubin \<1.5xULN)
* Platelets \> 80000 cells/mm3; absolute neutrophil count (ANC) \< 1500 cells/mm3
* BMI \< 17
* Patients with reduced nutritional status
* Ileus within the last 30 days
* Brain metastases in cancer history
* Pregnant and nursing women
* history of myocardial infarction, congestive heart failure or relevant cardiac arrhythmia within previous 3 months
* inadequate respiratory function in option of investigator
B: Inclusion Criteria:

* Patients with stage III or IV ovarian cancer who have completed a course of platinin-based cytotoxic therapy after debulking surgery with evidence of a complete or partial response by radiological imaging. Patients with metastatic ovarian cancer who have stable disease for greater than 3 months after completion of first-line therapy.
* Patients with stage IV breast cancer who have received at least 1 course of hormonal or cytotoxic therapy for metastatic cancer. Patients must be off cytotoxic therapy with stable disease or better for 3 months or greater duration. Patients may have stable disease and still be on hormonal therapy.
* Patients with prostate cancer who have failed at least 1 course of an accepted hormonal therapy. Specifically prostate cancer patients must have castrate testosterone levels (\< 50 ng/dl) and 2 PSA values higher than the previously documented baseline at least 3 weeks apart or evidence of increases in measurable disease. These patients may have received previous courses of cytotoxic chemotherapy although chemotherapy naïve patients who are deemed not good candidates or who have refused cytotoxic therapy will be eligible. These patients may remain on anti-androgen therapy during the trial. Patients with evidence of progressive bone or other metastases are acceptable.
* At least 8 weeks since previous courses of an investigational biologic therapy (i.e. cancer vaccine) including active or passive immunotherapy.
* At least 30 days since localized surgery or radiotherapy.
* At least 30 days since initiation of a biphosphonate treatment.
* HLA A2 haplotype.

Exclusion Criteria:

* History of autoimmune disease, such as inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis. Patients with a remote history (greater than five years) of thyroiditis are not excluded.
* Presence of an acute infection requiring antibiotics within 4 weeks of study entry or a chronic infection such as: urinary tract infection, HIV, or antigen positive viral hepatitis.
* Previously resected brain metastases unless a CT or MRI scan of the brain shows no metastasis within 1 month of receiving DPX-0907.
* Concurrent (within the last 5 years) second malignancy other than non-melanoma skin cancer, cervical carcinoma in situ, or controlled bladder cancer.
* Acute or chronic skin disorders that will interfere with subcutaneous injection of the vaccine or subsequent assessment of potential skin reactions.
* Serious intercurrent chronic or acute illness, such as cardiac disease (NYHA class III or IV) or hepatic disease.
* Steroid therapy or other immunosuppressives, such as azathioprine or cyclosporin A, unless steroids are discontinued 6 weeks prior to study.
* Allergies to any component of the vaccine.
* Inability to gain venous access.
* Previous splenectomy.
* Previous lymphadenectomy in both inguinal regions.
* Pregnant or nursing mothers.
* Medical or psychological impediment or active drug or alcohol use that might preclude protocol compliance.
C: Inclusion Criteria:

Among other criteria, patients must meet all of the following conditions to be eligible to be in the study:

1. 18 years of age or older.
2. Have a cancer type that is known to express NY-ESO-1, including (but not limited to) cancer of the bladder, breast, ovary, non-small cell lung cancer, myeloma, sarcoma or melanoma.
3. Have cancer that has progressed after any therapies with curative potential or approved salvage therapies (if such therapies exist).
4. Have evaluable or measurable tumors.
5. Have adequate blood, bone marrow, liver and kidney function as determined by laboratory tests.
6. Have a sample of tumor tissue available for NY-ESO-1 testing at a central laboratory.
7. If of childbearing potential (male or female), agree to practice an effective form of contraception during study treatment.

Exclusion Criteria:

Among other criteria, patients who meet any of the following conditions are NOT eligible to be in the study:

1. Are receiving treatment with immunosuppressive or immunomodulatory agents, including any systemic steroid (inhaled or topically applied steroids are permitted).
2. Has a known infection with HIV, HBV or HCV, or any other active infection requiring systemic antibiotic treatment.
3. Has active central nervous system tumors.
4. Any underlying medical condition that in the Principal Investigator's opinion will make the administration of study drug hazardous or otherwise interfere with the study.
D: Inclusion Criteria:

At a maximum of 12 weeks after the last cycle of first line standard platinum/taxane intravenous (IV) or intraperitoneal (IP) chemotherapy, patients must fulfill all the following inclusion criteria:

* Age \>/= 18 years;
* Properly executed written informed consent;
* History of histological and CA125 (\> 35 U/ml) confirmed diagnosis of stage III-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer;
* History of debulking surgery and 6-8 cycles of standard platinum/taxane based non-investigational IV-IP chemotherapy;
* Complete clinical response defined as:
* Normal physical examination;
* No symptoms suggestive of persistent cancer;
* No definite evidence of disease by computed tomography (CT) of the abdomen and pelvis within the previous 4 weeks;
* Negative chest x-ray (or chest CT scan) within the previous 4 weeks;
* Serum CA125 within the normal laboratory range.
* Adequate hematologic, renal and hepatic function:

  * Absolute Neutrophil Count (ANC) \>/=1.5 \* 109/l;
  * Platelets \>/= 75 \* 109/l;
  * Haemoglobin \>/= 6.2 mmol/l (\>9.9 g/dl);
  * Serum creatinine \</= 1.5 \* ULN (Upper Limit of Normal);
  * Bilirubin \</= 1.5 \* ULN; AST, ALT, AP \</= 2.5 \* ULN.
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) \</= 2.

Exclusion Criteria:

Patients are ineligible to participate in the study, if any of the following criteria are present:

* any other invasive malignancies, with the exception of non-melanoma skin cancer or cervical carcinoma in situ, within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy;
* known active autoimmune disease requiring chronic treatment with immunosuppressive agents (e.g., rheumatoid arthritis, ulcerative colitis, etc.);
* known immune deficiency (e.g. HIV, hypogammaglobulinemia, etc.);
* known infection with hepatitis B, or hepatitis C;
* history of recent myocardial infarction (\</= 6 months) or decompensated heart failure (New York Heart Association - NYHA class \>/= III);
* previous or concomitant use of any anti-cancer therapy other than the platinum-taxane based 1st line chemotherapy for ovarian cancer; any maintenance or consolidation therapy is not permitted after completion of standard front line chemotherapy.
* concomitant use of any other investigational agent;
* any prior investigational anti-cancer vaccine or monoclonal antibody;
* known allergy to murine proteins;
* any significant medical or psychiatric condition, drug or alcohol abuse that might prevent the patient from complying with all study procedures;
* clinically significant active infection;
* concomitant use of any immunosuppressive agent (e.g., steroids, cyclosporin, etc.);
* major surgery within the previous 2 weeks;
* radiotherapy within the previous 4 weeks;
* any significant toxicity from prior chemotherapy;
* unreliability or inability to follow protocol requirements;
* potentially childbearing and not willing to use adequate contraceptive methods throughout the entire study period;
* pregnancy.

Answer: D