Phase 1
N=28
Phase 1 Study of NY-ESO-1 Overlapping Peptides in Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Epithelial Ovarian Cancer · Fallopian Tube Cancer · Primary Peritoneal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00616941 ↗Enrolled (actual)
28
Serious AEs
3.6%
Results posted
Jul 2018
Primary outcome: Primary: Overview of Treatment-emergent Adverse Events (TEAEs) — 3; 13; 11; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- NY-ESO-1 OLP4 (Biological); NY-ESO-1 OLP4 + Montanide (Biological); NY-ESO-1 OLP4 + Montanide + Poly-ICLC (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Ludwig Institute for Cancer Research
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overview of Treatment-emergent Adverse Events (TEAEs) |
3; 13; 11; 2; 12; 11 | — |
| SECONDARY Number of Patients With Detectable Serum Immunoglobulin G (IgG) Antibody Titers Against NY-ESO-1 Up to 16 Weeks Post-Baseline |
1; 0; 1; 1; 0; 1 | — |
| SECONDARY Number of Patients With Detectable CD8+ and CD4+ T-cell Responses Up to 16 Weeks Post-Baseline |
1; 9; 10; 4; 13; 11 | — |
| SECONDARY Number of Patients With Delayed-type Hypersensitivity (DTH) Reactions (Induration and Redness) to NY-ESO-1 OLP4 at Screening and Week 16 |
0; 0; 0; 1; 4; 2 | — |
| SECONDARY Cancer Antigen (CA)-125 Levels Up to 16 Weeks Post-Baseline |
14.0; 8.5; 10.9; 29.5; 13.8; 21.3 | — |
| SECONDARY Tumor Measurement Results According to the Response Evaluation Criteria for Solid Tumors (RECIST) Up to 16 Weeks Post-Baseline |
0; 0; 0; 1; 0; 1 | — |
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
- 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.
- 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.
- Expected survival of at least 4 months.
- Karnofsky performance scale ≥ 70%.
- 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
- Age ≥ 18 years.
- ≥ 4 weeks since completion of prior cytotoxic chemotherapy.
- Able and willing to give valid written informed consent
Exclusion Criteria
- Clinically significant heart disease (New York Heart Association Class III or IV).
- Serious intercurrent illness, eg, serious infections requiring prolonged parenteral antibiotics or bleeding disorders requiring hospitalization.
- Positive stool guaiac excluding hemorrhoids.
- 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.
- Other malignancy within 3 years prior to entry into the study, except for treated non-melanoma skin cancer and cervical carcinoma in situ.
- History of previous severe allergic reactions to vaccines or unknown allergens.
- Mental impairment that may have compromised the ability to give informed consent and comply with the requirements of the study.
- Lack of availability for immunological and clinical follow-up assessments.
- Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dose of study agent.
- Pregnancy or breast-feeding.
- Women of childbearing potential: Refusal or inability to use effective means of contraception.
Data sourced from ClinicalTrials.gov (NCT00616941). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.