Vaccine Therapy in Treating Patients With Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
Condition: Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer
MeSH terms: Fallopian Tube Neoplasms
Intervention: NY-ESO-1 peptide vaccine
Intervention description: NY-ESO-1b peptide 100 μg mixed with 0.5 mL of Montanide® ISA-51
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage II ovarian epithelial cancer; stage III ovarian epithelial cancer; stage IV ovarian epithelial cancer; primary peritoneal cavity cancer; fallopian tube cancer

Summary:

      RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

      PURPOSE: A phase I trial to study the side effects of vaccine therapy in patients with
      ovarian epithelial, primary peritoneal, or fallopian tube cancer.
    

Eligibility criteria:

        Inclusion Criteria

          1. Histologically documented epithelial carcinoma arising in the ovary, fallopian tube,
             or peritoneum, from Stage II-IV at diagnosis, receiving initial cytoreductive surgery
             and chemotherapy with at least one platinum-based chemotherapy regimen.

          2. High risk feature defined as suboptimal primary debulking (remaining tumor masses with
             diameter ≥ 1.0 cm) or failure to normalize CA125 during primary therapy by the end of
             the third cycle or positive second-look surgery.

          3. Patients must be in complete clinical remission defined as CA125 < 35 units, negative
             physical examination and no definite evidence of disease by computed tomography (CT)
             of the abdomen and pelvis. Lymph nodes and/or soft tissue abnormalities ≤ 1.0 cm that
             are often present in the pelvis may not be considered definite evidence of disease.

          4. Expected survival of at least 6 months.

          5. Karnofsky performance scale ≥60%.

          6. Within the last 2 weeks prior to study day 1, vital laboratory parameters should be
             within normal range, except for the following laboratory parameters, which should be
             within the ranges specified:

               -  Absolute neutrophil count (ANC) ≥1000/mm^3

               -  Platelets ≥ 80,000/mm^3

               -  Creatinine ≤ 1.5mg/dL

               -  Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), and total
                  bilirubin all < 2.5 x upper limit of normal (ULN) 7 Age ≥ 18 years.

        8. Able and willing to give valid written informed consent. 9. HLA A02 positive. Exclusion
        Criteria

        Patients were excluded from the study for any of the following reasons:

          1. Clinically significant heart disease (NYHA Class III or IV).

          2. Other serious illnesses, e.g., serious infections requiring antibiotics or bleeding
             disorders.

          3. Patients with serious intercurrent illness, requiring hospitalization.

          4. Metastatic disease to the central nervous system for which other therapeutic options,
             including radiotherapy, may be available.

          5. Patients taking immunosuppressive drugs such as systemic corticosteroids or
             non-steroidal anti-inflammatory drugs.

          6. Known HIV positivity.

          7. Other malignancy within 3 years prior to entry into the study, except for treated
             nonmelanoma skin cancer and cervical carcinoma in situ.

          8. Mental impairment that may compromise the ability to give informed consent and comply
             with the requirements of the study.

          9. Lack of availability for immunological and clinical follow-up assessments.

         10. Participation in any other clinical trial involving another investigational agent
             within 4 weeks prior to enrollment.

         11. Pregnancy or breastfeeding.

         12. Women of childbearing potential: Refusal or inability to use effective means of
             contraception.