NCT00616941

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2008

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 15, 2008

Completed
15 days until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
7.2 years until next milestone

Results Posted

Study results publicly available

July 27, 2018

Completed
Last Updated

October 12, 2022

Status Verified

October 1, 2022

Enrollment Period

3.3 years

First QC Date

February 4, 2008

Results QC Date

April 28, 2017

Last Update Submit

October 3, 2022

Conditions

Epithelial Ovarian CancerFallopian Tube CancerPrimary Peritoneal Cancer

Keywords

NY-ESO-1 OLP4Ovarian CancerCancer Vaccine

Outcome Measures

Primary Outcomes (1)

  • Overview of Treatment-emergent Adverse Events (TEAEs)

    Analysis of TEAEs reported from clinical laboratory tests, physical examinations, and vital signs from pre-treatment through 3 weeks after the last dose of study treatment.

    Continuously for up to 16 weeks

Secondary Outcomes (5)

  • Number of Patients With Detectable Serum Immunoglobulin G (IgG) Antibody Titers Against NY-ESO-1 Up to 16 Weeks Post-Baseline

    Screening and Weeks 4, 7, 10, 13, and 16

  • Number of Patients With Detectable CD8+ and CD4+ T-cell Responses Up to 16 Weeks Post-Baseline

    Screening and Weeks 4, 7, 10, 13, and 16

  • Number of Patients With Delayed-type Hypersensitivity (DTH) Reactions (Induration and Redness) to NY-ESO-1 OLP4 at Screening and Week 16

    Screening and Week 16

  • Cancer Antigen (CA)-125 Levels Up to 16 Weeks Post-Baseline

    Screening, Week 7, and Week 16

  • Tumor Measurement Results According to the Response Evaluation Criteria for Solid Tumors (RECIST) Up to 16 Weeks Post-Baseline

    Screening and every 2 months up to Week 16

Study Arms (3)

Cohort 1

EXPERIMENTAL

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.

Biological: NY-ESO-1 OLP4

Cohort 2

EXPERIMENTAL

Subjects received 4 synthetic peptides coded by the NY-ESO-1 gene (ie, NY-ESO-1 OLP4) in combination with Montanide ISA-51 vegetable grade (VG) once every 3 weeks for a total of 5 vaccinations.

Biological: NY-ESO-1 OLP4 + Montanide

Cohort 3

EXPERIMENTAL

Subjects received 4 synthetic peptides coded by the NY-ESO-1 gene (ie, NY-ESO-1 OLP4) in combination with Montanide ISA-51 VG and poly-ICLC once every 3 weeks for a total of 5 vaccinations.

Biological: NY-ESO-1 OLP4 + Montanide + Poly-ICLC

Interventions

NY-ESO-1 OLP4BIOLOGICAL

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.

Cohort 1
NY-ESO-1 OLP4 + MontanideBIOLOGICAL

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.

Cohort 2
NY-ESO-1 OLP4 + Montanide + Poly-ICLCBIOLOGICAL

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.

Cohort 3

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSubjects must have had selected female reproductive organ cancers.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Publications (2)

  • Sabbatini P, Tsuji T, Ferran L, Ritter E, Sedrak C, Tuballes K, Jungbluth AA, Ritter G, Aghajanian C, Bell-McGuinn K, Hensley ML, Konner J, Tew W, Spriggs DR, Hoffman EW, Venhaus R, Pan L, Salazar AM, Diefenbach CM, Old LJ, Gnjatic S. Phase I trial of overlapping long peptides from a tumor self-antigen and poly-ICLC shows rapid induction of integrated immune response in ovarian cancer patients. Clin Cancer Res. 2012 Dec 1;18(23):6497-508. doi: 10.1158/1078-0432.CCR-12-2189. Epub 2012 Oct 2.

    PMID: 23032745RESULT

  • Tsuji T, Sabbatini P, Jungbluth AA, Ritter E, Pan L, Ritter G, Ferran L, Spriggs D, Salazar AM, Gnjatic S. Effect of Montanide and poly-ICLC adjuvant on human self/tumor antigen-specific CD4+ T cells in phase I overlapping long peptide vaccine trial. Cancer Immunol Res. 2013 Nov;1(5):340-50. doi: 10.1158/2326-6066.CIR-13-0089. Epub 2013 Sep 16.

    PMID: 24777970DERIVED

MeSH Terms

Conditions

Carcinoma, Ovarian EpithelialFallopian Tube NeoplasmsOvarian Neoplasms

Interventions

Monatide (IMS 3015)poly ICLC

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersFallopian Tube Diseases

Results Point of Contact

Title
Jonathan Skipper PhD
Organization
Ludwig Institute for Cancer Research
jskipper@lcr.org
12124501539

Study Officials

  • Paul Sabbatini, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2008

First Posted

February 15, 2008

Study Start

March 1, 2008

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

October 12, 2022

Results First Posted

July 27, 2018

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will share

Data have been published

Locations

US(1)