Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Open-label Phase IIb Trial of Maintenance Therapy With a MUC1 Dendritic Cell Vaccine (Cvac™) for Epithelial Ovarian Cancer Patients in First or Second Remission
Brief Summary: The purpose of this study is to determine the safety and efficacy of an investigational therapeutic agent (Cvac) in ovarian cancer patients in first or second remission and to determine its ability to prevent cancer from returning.

Study objectives

Primary objectives:

* To confirm the safety of administering Cvac in this population.
* To determine the effects of Cvac on progression-free survival (PFS).

Secondary objectives:

* To determine overall survival (OS) for ovarian cancer patients who receive Cvac after achieving remission in the first or second-line setting.
* Evaluation of host immunologic response to Cvac administration.


Options:
A: 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.
B: 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.
C: 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
D: Inclusion Criteria:

* Female subjects ≥ 18 years old with histologically confirmed Stage III or IV epithelial ovarian, primary peritoneal or fallopian tube cancer who have previously undergone surgical cytoreduction and received first or second line conventional chemotherapy and are currently in complete remission (based on clinical and radiologic studies).
* Cancer antigen (CA)-125 ≤ upper limit of normal with a prior history of an elevated CA-125.
* Able and willing to undergo mononuclear cell collection.
* Not more than 12 weeks between enrollment and the last dose of chemotherapy that resulted in complete remission.
* No prior surgery to the peritoneum or pleural space within 28 days of enrollment, excluding removal of catheters used for chemotherapy administration.
* No prior treatment with an investigational product within 30 days of enrollment.
* Baseline electrocardiogram within normal limits or any abnormalities deemed not indicative of cardiac disease for which intervention is required.
* Serum creatinine ≤ 2 mg/dL.
* Serum aspartate aminotransferase or serum alanine aminotransferase ≤ 2.5x the upper limit of normal or serum total bilirubin ≤ 1.5x the upper limit of normal.
* White blood cell count ≥ 3.0 K/µL; absolute neutrophil count ≥ 1.5K/µL; hemoglobin ≥ 9.0 g/dL, and platelets ≥ 100,000/mm\^3. (These complete blood count results are required for enrollment. It should be noted that complete blood count results, including monocyte count ≥ 0.2 × 10\^9/L, will be needed prior to leukapheresis to determine if sufficient dendritic cells can be obtained for Cvac™ manufacture.)
* Life expectancy of at least 12 months.
* Eastern Cooperative Oncology Group Performance Status of 0-1.
* All toxicities from prior therapies, excluding alopecia, must have resolved to Common Terminology Criteria for Adverse Events Grade ≤ 1.
* Must be non-pregnant and, if of childbearing potential, must use adequate birth control (hormonal or barrier method of birth control or abstinence) for the duration of the study and for 3 months after study completion.
* Able to provide written informed consent.

Exclusion Criteria:

* Coexisting or other malignancies unless in complete remission for not less than 3 years. Does not include in situ carcinoma of the cervix or basal cell or squamous cell carcinoma of the skin for which no restrictions apply, assuming they have been adequately treated.
* Ovarian germ cell, sarcoma, or mixed Mullerian tumors.
* Prior cancer vaccine or cellular therapy.
* Active uncontrolled infections or any organ system toxicity ≥ Grade 2 by Common Terminology Criteria for Adverse Events criteria.
* Inability to provide informed consent or to comply with study-related procedures.
* Concurrent systemic treatment with steroids or other immunosuppressive agents.
* Diagnosed immunodeficiency and/or autoimmune disorders.
* Myocardial infarction in the past 6 months and/or clinically significant heart disease.
* Infection with human immunodeficient virus (HIV), hepatitis B or C virus.
* Pregnant or breastfeeding.
* Evidence or history of central nervous system metastases.
* Full dose anticoagulation therapy administered within 7 days of leukapheresis procedure.
* Hematopoietic growth factors administered within 14 days of enrollment.

Answer: D