Decitabine, Vaccine Therapy, and Pegylated Liposomal Doxorubicin Hydrochloride in Treating Patients With Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer
NCT ID: NCT01673217
Last Updated: 2022-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
18 participants
INTERVENTIONAL
2009-04-30
2013-06-30
Brief Summary
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Detailed Description
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I. To determine the safety of 5-aza-2'-deoxycytidine (decitabine) in combination with immunization with NYESO-I protein mixed with montanide and granulocyte-macrophage colony stimulating factor (GM-CSF) in patients scheduled to receive liposomal doxorubicin for recurrent epithelial ovarian, fallopian tube or primary peritoneal carcinoma.
SECONDARY OBJECTIVES:
I. To evaluate NY-ESO-l specific cellular and humoral immunity by determination of NY-ESO-I specific antibody, CD8+ and CD4+ T-cells following immunization with NY-ESO-l protein mixed with montanide and GM-CSF in combination with 5-aza-2' -deoxycytidine (decitabine) in patients receiving liposomal doxorubicin for recurrent epithelial ovarian, fallopian tube or primary peritoneal carcinoma.
II. To determine the impact of 5-aza-2'-deoxycytidine on NY-ESO-I specific expression, NY-ESO-l promoter methylation, and global DNA methylation.
III. To compare the time to progression (ttp) for the proposed therapy with the ttp for standard therapy (historical studies).
OUTLINE: This is a dose escalation study of decitabine.
Patients receive decitabine intravenously (IV) over 3 hours on day 1, pegylated liposomal doxorubicin hydrochloride IV on day 8, and NY-ESO-1 peptide vaccine emulsified in incomplete Freund's adjuvant and sargramostim subcutaneously on day 15. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 6 months.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (chemotherapy and vaccine therapy)
Patients receive decitabine IV over 3 hours on day 1, pegylated liposomal doxorubicin hydrochloride IV on day 8, and NY-ESO-1 peptide vaccine emulsified in incomplete Freund's adjuvant and sargramostim subcutaneously on day 15. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.
decitabine
Given IV
NY-ESO-1 peptide vaccine
Given SC
pegylated liposomal doxorubicin hydrochloride
Given IV
sargramostim
Given SC
incomplete Freund's adjuvant
Given SC
immunohistochemistry staining method
Correlative studies
liquid chromatography
Correlative studies
mass spectrometry
Correlative studies
reverse transcriptase-polymerase chain reaction
Correlative studies
laboratory biomarker analysis
Correlative studies
DNA methylation analysis
Correlative studies
enzyme-linked immunosorbent assay
Correlative studies
Interventions
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decitabine
Given IV
NY-ESO-1 peptide vaccine
Given SC
pegylated liposomal doxorubicin hydrochloride
Given IV
sargramostim
Given SC
incomplete Freund's adjuvant
Given SC
immunohistochemistry staining method
Correlative studies
liquid chromatography
Correlative studies
mass spectrometry
Correlative studies
reverse transcriptase-polymerase chain reaction
Correlative studies
laboratory biomarker analysis
Correlative studies
DNA methylation analysis
Correlative studies
enzyme-linked immunosorbent assay
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients may have received up to four previous lines of chemotherapy
* The relapse may be defined by an increase in CA125; there may or may not be either measurable or symptomatic disease
* Any human leukocyte antigen (HLA) type
* No requirement for tumor expression of NY-ESO-1
* Karnofsky performance status of \> 70%
* Not previously treated with doxorubicin
* Life expectancy \>= 6 months
* Hematology and biochemistry laboratory results within the limits normally expected for the patient population, without evidence of major organ failure
* No immunodeficiency
* Have been informed of other treatment options
* Able and willing to give valid written informed consent
* Neutrophil count \>= 1.5 x 10\^9
* Platelet count \>= 100 x 10\^9
* Serum creatinine =\< 2.1 mg/dL
* Serum bilirubin =\< 2 mg/dL
* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2.6 x upper limit of normal (ULN) (normal ranges: AST 15-46 U/L; ALT 11-66 U/L)
Exclusion Criteria
* Other serious illnesses (e.g., serious infections requiring antibiotics, bleeding disorders)
* History of autoimmune disease (e.g., thyroiditis, lupus) except vitiligo
* Concomitant systemic treatment with corticosteroids, anti-histamine or non-steroidal anti-inflammatory drugs; specific CQX-2 inhibitors are permitted
* Chemotherapy, radiation therapy, or immunotherapy within 4 weeks prior to first dosing of study agent (6 weeks for nitrosoureas)
* Known human immunodeficiency virus (HIV) positivity
* Known allergy or history of life threatening reaction to GM-CSF
* Myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, chest pain or shortness of breath with activity, or other heart conditions being treated by a doctor
* Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dosing of study agent
* Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study
* Lack of availability of a patient for immunological and clinical follow-up assessment
18 Years
FEMALE
No
Sponsors
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Eisai Inc.
INDUSTRY
Roswell Park Cancer Institute
OTHER
Responsible Party
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Principal Investigators
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Kunle Odunsi
Role: PRINCIPAL_INVESTIGATOR
Roswell Park Cancer Institute
Locations
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Roswell Park Cancer Institute
Buffalo, New York, United States
Countries
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Other Identifiers
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NCI-2010-00105
Identifier Type: REGISTRY
Identifier Source: secondary_id
I 127008
Identifier Type: -
Identifier Source: org_study_id
NCT00887796
Identifier Type: -
Identifier Source: nct_alias
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