NCT00066729

Brief Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: A phase I trial to study the side effects of vaccine therapy in patients with ovarian epithelial, primary peritoneal, or fallopian tube cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2003

Longer than P75 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

Study Start

First participant enrolled

June 23, 2003

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 6, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 7, 2003

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2006

Completed
7.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
8.1 years until next milestone

Results Posted

Study results publicly available

September 16, 2021

Completed
Last Updated

October 4, 2023

Status Verified

October 1, 2023

Enrollment Period

2.9 years

First QC Date

August 6, 2003

Results QC Date

August 17, 2021

Last Update Submit

October 2, 2023

Conditions

Fallopian Tube CancerOvarian CancerPrimary Peritoneal Cavity Cancer

Keywords

stage II ovarian epithelial cancerstage III ovarian epithelial cancerstage IV ovarian epithelial cancerprimary peritoneal cavity cancerfallopian tube cancer

Outcome Measures

Primary Outcomes (1)

  • Number of Patients With Dose Limiting Toxicities (DLTs)

    Toxicities and adverse events defined by National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999). DLT defined as: ≥ Grade 2 autoimmune phenomena, asymptomatic bronchospasm or generalized urticaria, or ≥ Grade 3 hematological and non hematological toxicities. To be dose-limiting, an adverse event must be definitely, probably, or possibly related to the administration of the investigational agent.

    up to 16 weeks

Secondary Outcomes (4)

  • Number of Patients Developing NY-ESO-1 Antibodies After Treatment

    up to 16 weeks

  • Number of Patients With NY-ESO-1b-Specific CD8+ T Cells Measured by Tetramer Analysis

    up to 16 weeks.

  • Number of Patients With NY-ESO-1b-Specific Activated CD8+ T Cells Measured by ELISPOT

    up to 16 weeks

  • Number of Patients With NY-ESO-1b-specific Delayed-type Hypersensitivity (DTH)

    up to 16 weeks

Study Arms (1)

NY-ESO-1b peptide with Montanide® ISA-51

EXPERIMENTAL

Patients received NY-ESO-1b peptide mixed with Montanide® ISA-51 by subcutaneous injections, once every 3 weeks (weeks 1, 4, 7, 10, and 13) for a total of 13 weeks.

Biological: NY-ESO-1 peptide vaccine

Interventions

NY-ESO-1 peptide vaccineBIOLOGICAL

NY-ESO-1b peptide 100 μg mixed with 0.5 mL of Montanide® ISA-51

NY-ESO-1b peptide with Montanide® ISA-51

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
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, from Stage II-IV at diagnosis, receiving initial cytoreductive surgery and chemotherapy with at least one platinum-based chemotherapy regimen.
  • High risk feature defined as suboptimal primary debulking (remaining tumor masses with diameter ≥ 1.0 cm) or failure to normalize CA125 during primary therapy by the end of the third cycle or positive second-look surgery.
  • Patients must be in complete clinical remission defined as CA125 \< 35 units, negative physical examination and 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 may not be considered definite evidence of disease.
  • Expected survival of at least 6 months.
  • Karnofsky performance scale ≥60%.
  • Within the last 2 weeks prior to study day 1, vital laboratory parameters should be within normal range, except for the following laboratory parameters, which should be within the ranges specified:
  • Absolute neutrophil count (ANC) ≥1000/mm\^3
  • Platelets ≥ 80,000/mm\^3
  • Creatinine ≤ 1.5mg/dL
  • Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), and total bilirubin all \< 2.5 x upper limit of normal (ULN) 7 Age ≥ 18 years.

You may not qualify if:

  • Patients were excluded from the study for any of the following reasons:
  • Clinically significant heart disease (NYHA Class III or IV).
  • Other serious illnesses, e.g., serious infections requiring antibiotics or bleeding disorders.
  • Patients with serious intercurrent illness, requiring hospitalization.
  • Metastatic disease to the central nervous system for which other therapeutic options, including radiotherapy, may be available.
  • Patients taking immunosuppressive drugs such as systemic corticosteroids or non-steroidal anti-inflammatory drugs.
  • Known HIV positivity.
  • Other malignancy within 3 years prior to entry into the study, except for treated nonmelanoma skin cancer and cervical carcinoma in situ.
  • Mental impairment that may compromise 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 enrollment.
  • Pregnancy or breastfeeding.
  • 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 (1)

  • Diefenbach CS, Gnjatic S, Sabbatini P, Aghajanian C, Hensley ML, Spriggs DR, Iasonos A, Lee H, Dupont B, Pezzulli S, Jungbluth AA, Old LJ, Dupont J. Safety and immunogenicity study of NY-ESO-1b peptide and montanide ISA-51 vaccination of patients with epithelial ovarian cancer in high-risk first remission. Clin Cancer Res. 2008 May 1;14(9):2740-8. doi: 10.1158/1078-0432.CCR-07-4619.

    PMID: 18451240RESULT

MeSH Terms

Conditions

Fallopian Tube NeoplasmsOvarian NeoplasmsCarcinoma, Ovarian Epithelial

Condition Hierarchy (Ancestors)

Genital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFallopian Tube DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesEndocrine Gland NeoplasmsOvarian DiseasesEndocrine System DiseasesGonadal DisordersCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Results Point of Contact

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

Study Officials

  • Jakob Dupont, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2003

First Posted

August 7, 2003

Study Start

June 23, 2003

Primary Completion

May 9, 2006

Study Completion

August 1, 2013

Last Updated

October 4, 2023

Results First Posted

September 16, 2021

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)