Vaccine Therapy in Patients With Stage II, III, or IV Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer
Condition: Fallopian Tube Cancer; Ovarian Cancer; Peritoneal Cavity Cancer
MeSH terms: Fallopian Tube Neoplasms
Intervention: rV-NY-ESO-1 vaccine; rF-NY-ESO-1 vaccine
Intervention description: Patients received a single intradermal injection of rV-NY-ESO-1 (3.1 × 10^7 PFU) on Day 1.; Patients received subcutaneous injections of rF-NY-ESO-1 (7.41 × 10^7 PFU) on Days 29, 57, 85, 113, 141, and 169.
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: fallopian tube cancer; stage II ovarian epithelial cancer; stage III ovarian epithelial cancer; stage IV ovarian epithelial cancer; peritoneal cavity cancer

Summary:

      This was a Phase 2, single-center, open-label study of recombinant vaccinia-NY-ESO-1
      (rV-NY-ESO-1) and recombinant fowlpox-NY-ESO-1 (rF-NY-ESO-1) injections in patients who had a
      complete response to standard therapy for epithelial ovarian, fallopian tube, or primary
      peritoneal carcinoma and whose tumors expressed NY-ESO-1 or LAGE-1 antigen. Study objectives
      were to evaluate maintenance of remission at 12 months, time to failure of vaccine therapy,
      cellular and humoral immunity and any correlation with time to failure, and safety.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Histologically documented epithelial carcinoma arising in the ovary, fallopian tube,
             or peritoneum, from stage II to IV at diagnosis.

          2. Received initial surgery and chemotherapy with at least one platinum-based
             chemotherapy regimen.

          3. Demonstrated complete response to first line therapy as evidenced by negative clinical
             examination, cancer antigen (CA)-125 tumor marker, and computed tomography (CT) scan.
             In addition, if second-look surgery was performed, patients must have had no evidence
             of microscopic or macroscopic disease. Patients must have been within 6 months of
             completing their first line platinum-based chemotherapy. These patients would normally
             enter a period of observation as standard management.

          4. Tumor expression of 1) NY-ESO-1 by reverse transcription-polymerase chain reaction
             (RT-PCR) analysis, preferably, or immunohistochemistry; or 2) LAGE-1 by RT-PCR.

          5. Expected survival of at least 6 months.

          6. Full recovery from surgery.

          7. Karnofsky performance status of 70% or more.

          8. Patients must have had the following clinical laboratory results:

               -  neutrophil count: ≥ 1.5 x 10^9/L

               -  lymphocyte count: ≥ 0.5 x 10^9/L

               -  platelet count: ≥ 100 x 10^9/L

               -  serum creatinine: ≤ 2 mg/dL

               -  serum bilirubin: ≤ 2 mg/dL

          9. Ability to avoid close contact with children < 3 years of age; pregnant or breast
             feeding women; individuals with active, or a history of, eczema or atopic dermatitis
             or other skin disorders such as burns, chickenpox, shingles, impetigo, herpes, severe
             acne, or psoriasis; and immunocompromised individuals (human immunodeficiency virus
             [HIV], leukemia, lymphoma, solid organ transplantation, generalized malignancy,
             cellular or humoral immunodeficiency syndromes, patients currently receiving cytotoxic
             chemotherapies, radiation, or high dose corticosteroids).

         10. Have been informed of other treatment options.

         11. Age ≥ 18 years.

         12. Able and willing to give valid written informed consent.

        Exclusion Criteria:

          1. Metastatic disease to the central nervous system for which other therapeutic options,
             including radiotherapy, may have been available.

          2. Other serious illnesses (eg, serious infections requiring antibiotics, bleeding
             disorders).

          3. History of current eczema or atopic dermatitis.

          4. History of autoimmune disease (eg., thyroiditis, lupus).

          5. Other acute, chronic, or exfoliative skin conditions such as burns, chickenpox,
             shingles, impetigo, herpes, severe acne, or psoriasis.

          6. Concomitant systemic treatment with corticosteroids, anti-histamine or non-steroidal
             anti-inflammatory drugs. Specific cyclooxygenase-2 inhibitors were permitted.

          7. Chemotherapy, radiation therapy, or immunotherapy within 4 weeks before study entry (6
             weeks for nitrosoureas).

          8. Known HIV positivity.

          9. Known allergy or severe reaction to a smallpox (vaccinia) vaccination.

         10. Known allergy to eggs, determined by history.

         11. Myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or
             transient ischemic attack, chest pain or shortness of breath with activity, or other
             heart conditions being treated by a doctor.

         12. Presence of 3 or more of the following risk factors:

               -  Hypertension

               -  Hypercholesterolemia

               -  Diabetes

               -  A first degree relative (for example, mother, father, brother, sister) who had a
                  heart condition before the age of 50

               -  Current cigarette smoker

         13. Participation in any other clinical trial involving another investigational agent
             within 4 weeks prior to enrollment.

         14. Mental impairment that may have compromised the ability to give informed consent and
             comply with the requirements of the study.

         15. Lack of availability of a patient for immunological and clinical follow-up assessment.