Brief Title
Phase 1 Study of NY-ESO-1 Overlapping Peptides in Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Official Title
A Phase 1 Study of NY-ESO-1 Overlapping Peptides With or Without Immunoadjuvants Montanide and Poly-ICLC Vaccination of Epithelial Ovarian Cancer, Fallopian Tube, or Primary Peritoneal Cancer Patients in Second or Third Remission
Brief 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.
Detailed Description
Subjects received NY-ESO-1 OLP4 by subcutaneous injection once every 3 weeks (Weeks 1, 4, 7,
10, and 13) for a total of 5 vaccinations.
Subjects were assigned sequentially to 1 of 3 dosing cohorts:
Cohort 1: received NY-ESO-1 OLP4 alone; Cohort 2: received NY-ESO-1 OLP4 in combination with
Montanide; Cohort 3: received NY-ESO-1 OLP4 in combination with Montanide and Poly-ICLC.
Enrollment into each subsequent dosing cohort was dependent on a dose-limiting toxicity (DLT)
rate of <33% in the preceding cohort. No dose escalation was planned.
Subjects were observed by study staff for up to 30 minutes following each vaccination.
Immunologic assessments were performed prior to the first vaccination and 3 weeks after each
vaccination. Toxicity assessments were performed with each vaccination and 3 weeks after the
completion of therapy (ie, the final study visit was Week 16). Immunologic assessments
included measurement of the anti-NY-ESO-1 antibody by enzyme-linked immunsorbent assay
(ELISA), detection of CD-4 and CD-8 cellular responses by tetramer and enzyme-linked
immunosorbent spot assay (ELISPOT), and delayed-type hypersensitivity (DTH).
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Overview of Treatment-emergent Adverse Events (TEAEs)
Secondary Outcome
Number of Patients With Detectable Serum Immunoglobulin G (IgG) Antibody Titers Against NY-ESO-1 Up to 16 Weeks Post-Baseline
Condition
Epithelial Ovarian Cancer
Intervention
NY-ESO-1 OLP4
Study Arms / Comparison Groups
Cohort 1
Description: Subjects received 4 synthetic peptides coded by the NY-ESO-1 gene (ie, NY-ESO-1 OLP4) once every 3 weeks for a total of 5 vaccinations.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
28
Start Date
March 2008
Completion Date
June 2011
Primary Completion Date
June 2011
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.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Paul Sabbatini, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00616941
Organization ID
LUD2006-001
Secondary IDs
MSKCC IRB# 07-152
Responsible Party
Sponsor
Study Sponsor
Ludwig Institute for Cancer Research
Collaborators
Memorial Sloan Kettering Cancer Center
Study Sponsor
Paul Sabbatini, MD, Principal Investigator, Memorial Sloan Kettering Cancer Center
Verification Date
October 2017