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Decitabine, Vaccine Therapy, and Pegylated Liposomal Doxorubicin Hydrochloride in Treating Patients With Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer

NCT01673217 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2022-08-01

No results posted yet for this study

Summary

This phase I trial is studying the side effects and best dose of decitabine when given together with pegylated liposomal doxorubicin hydrochloride and vaccine therapy in treating patients with recurrent ovarian epithelial cancer, fallopian tube cancer, or peritoneal cancer. Drugs used in chemotherapy, such as decitabine and pegylated liposomal doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vaccines made from a peptide or antigen may help the body build an effective immune response to kill tumor cells. Giving combination chemotherapy together with vaccine therapy may kill more tumor cells

Conditions

  • Recurrent Fallopian Tube Cancer
  • Recurrent Ovarian Epithelial Cancer
  • Recurrent Primary Peritoneal Cavity Cancer

Interventions

DRUG

decitabine

Given IV

BIOLOGICAL

NY-ESO-1 peptide vaccine

Given SC

DRUG

pegylated liposomal doxorubicin hydrochloride

Given IV

BIOLOGICAL

sargramostim

Given SC

BIOLOGICAL

incomplete Freund's adjuvant

Given SC

OTHER

immunohistochemistry staining method

Correlative studies

OTHER

liquid chromatography

Correlative studies

OTHER

mass spectrometry

Correlative studies

GENETIC

reverse transcriptase-polymerase chain reaction

Correlative studies

OTHER

laboratory biomarker analysis

Correlative studies

GENETIC

DNA methylation analysis

Correlative studies

OTHER

enzyme-linked immunosorbent assay

Correlative studies

Sponsors & Collaborators

  • Eisai Inc.

    collaborator INDUSTRY

  • Roswell Park Cancer Institute

    lead OTHER

Principal Investigators

  • Kunle Odunsi · Roswell Park Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2011-10-31
Completion
2013-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01673217 on ClinicalTrials.gov