Phase 1 Study of NY-ESO-1 Overlapping Peptides in Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Condition: Epithelial Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms; Peritoneal Neoplasms
Intervention: NY-ESO-1 OLP4; NY-ESO-1 OLP4 + Montanide; NY-ESO-1 OLP4 + Montanide + Poly-ICLC
Intervention description: 1.0 mg of NY-ESO-1 OLP4 (0.25 mg of each overlapping peptide) was diluted in 0.5 mL of 5% dextrose in water (D5W) and administered subcutaneously as a single injection.; 1.0 mg of NY-ESO-1 OLP4 (0.25 mg of each overlapping peptide) was diluted in 0.5 mL of D5W, mixed with 0.5 mL of Montanide, and administered subcutaneously as a single injection.; 1.0 mg of NY-ESO-1 OLP4 (0.25 mg of each overlapping peptide) and 1.4 mg of poly-ICLC were emulsified in 1.0 mL of Montanide and administered subcutaneously as two injections.
Intervention MeSH terms: Monatide (IMS 3015); Poly ICLC
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: NY-ESO-1 OLP4; Ovarian Cancer; Cancer Vaccine

Summary:

      This was a Phase 1, open-label study of repeated vaccination with NY-ESO-1 overlapping
      peptides (OLP4) with or without the immunoadjuvants Montanide and polyinosinic-polycytidylic
      acid - poly-L-lysine carboxymethylcellulose (poly-ICLC) administered every 3 weeks for a
      total of 5 vaccinations in subjects with epithelial ovarian, fallopian tube, or primary
      peritoneal cancer in second or third clinical remission. Study objectives included
      determination of the safety and immunogenicity following vaccination.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Histologically documented epithelial carcinoma arising in the ovary, fallopian tube,
             or peritoneum, stage II to IV at diagnosis, and post-initial cytoreductive surgery and
             chemotherapy with at least one platinum-based chemotherapy regimen.

          2. In second or third stable complete clinical remission, defined as a) stable cancer
             antigen (CA)-125 < 35 U/ml (defined as CA-125 that had not doubled from the post
             chemotherapy nadir), b) unremarkable physical examination, and c) 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 were not
             considered definite evidence of disease.

          3. Expected survival of at least 4 months.

          4. Karnofsky performance scale ≥ 70%.

          5. Laboratory values within the following limits:

               -  Hemoglobin ≥ 10.0 g/dL

               -  Neutrophil count ≥ 1.5 x 10^9/L

               -  Platelet count ≥ 80 x 10^9/L

               -  Serum creatinine ≤ 2.0 mg/dL

               -  Serum bilirubin ≤ 2.5 x institutional upper limit of normal (ULN)

               -  aspartate aminotransferase/alanine aminotransferase ≤ 2.5 x institutional ULN

          6. Age ≥ 18 years.

          7. ≥ 4 weeks since completion of prior cytotoxic chemotherapy.

          8. Able and willing to give valid written informed consent

        Exclusion Criteria:

          1. Clinically significant heart disease (New York Heart Association Class III or IV).

          2. Serious intercurrent illness, eg, serious infections requiring prolonged parenteral
             antibiotics or bleeding disorders requiring hospitalization.

          3. Positive stool guaiac excluding hemorrhoids.

          4. Known autoimmune disease (ie, rheumatoid arthritis, ulcerative colitis, etc); or
             immune deficiency (human immunodeficiency virus, hypogammaglobulinemia); or known
             active infections with Hepatitis B or Hepatitis C; or receipt of immunosuppressive
             drugs such as systemic corticosteroids or cyclosporin, etc.

          5. Other malignancy within 3 years prior to entry into the study, except for treated
             non-melanoma skin cancer and cervical carcinoma in situ.

          6. History of previous severe allergic reactions to vaccines or unknown allergens.

          7. Mental impairment that may have compromised the ability to give informed consent and
             comply with the requirements of the study.

          8. Lack of availability for immunological and clinical follow-up assessments.

          9. Participation in any other clinical trial involving another investigational agent
             within 4 weeks prior to first dose of study agent.

         10. Pregnancy or breast-feeding.

         11. Women of childbearing potential: Refusal or inability to use effective means of
             contraception.