| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2010-00105 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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| Name | Class |
|---|---|
| Eisai Inc. | INDUSTRY |
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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
PRIMARY OBJECTIVES:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (chemotherapy and vaccine therapy) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| decitabine | Drug | Given IV |
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| Measure | Description | Time Frame |
|---|---|---|
| Toxicity as assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 | Estimated with a one-sided, 95%, Wilson score binomial confidence interval. | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| NY-ESO-1 specific cellular and humoral immunity as assessed by NY-ESO-1-specific CD8+ and CD4+ T cells and antibodies and frequency of CD4+ CD25+ FOXP3+ regulatory T cells | Will be summarized by quartiles. Also, confidence intervals will be constructed for the median and the mean. | Up to 6 months |
| NY-ESO-l expression using Q-RT-PCR and IHC |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kunle Odunsi | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
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| NY-ESO-1 peptide vaccine | Biological | Given SC |
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| pegylated liposomal doxorubicin hydrochloride | Drug | Given IV |
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| sargramostim | Biological | Given SC |
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| incomplete Freund's adjuvant | Biological | Given SC |
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| immunohistochemistry staining method | Other | Correlative studies |
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| liquid chromatography | Other | Correlative studies |
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| mass spectrometry | Other | Correlative studies |
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| reverse transcriptase-polymerase chain reaction | Genetic | Correlative studies |
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| laboratory biomarker analysis | Other | Correlative studies |
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| DNA methylation analysis | Genetic | Correlative studies |
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| enzyme-linked immunosorbent assay | Other | Correlative studies |
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| Days 1, 8, 15, 36, 43, 64, 71, 92, and 99 |
| Time to progression | Summarized by a Kaplan-Meier survival curve. | Up to 6 months |
| NY-ESO-l promoter DNA methylation using pyrosequencing | Days 1, 8, 15, 36, 43, 64, 71, 92, and 99 |
| Global genomic DNA methylation using liquid chromatography-mass spectrometry (LC-MS) and LINE-l pyrosequencing | Days 1, 8, 15, 36, 43, 64, 71, 92, and 99 |
| ID | Term |
|---|---|
| D005185 | Fallopian Tube Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005184 | Fallopian Tube Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D010051 | Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| D000077209 | Decitabine |
| C506643 | liposomal doxorubicin |
| C081222 | sargramostim |
| D016178 | Granulocyte-Macrophage Colony-Stimulating Factor |
| C114843 | incomplete Freund's adjuvant |
| C477385 | montanide ISA 51 |
| D007150 | Immunohistochemistry |
| D002853 | Chromatography, Liquid |
| D013058 | Mass Spectrometry |
| D020133 | Reverse Transcriptase Polymerase Chain Reaction |
| D019175 | DNA Methylation |
| D004797 | Enzyme-Linked Immunosorbent Assay |
| ID | Term |
|---|---|
| D001374 | Azacitidine |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D006651 | Histocytochemistry |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006652 | Histological Techniques |
| D008919 | Investigative Techniques |
| D007158 | Immunologic Techniques |
| D002845 | Chromatography |
| D002623 | Chemistry Techniques, Analytical |
| D016133 | Polymerase Chain Reaction |
| D021141 | Nucleic Acid Amplification Techniques |
| D005821 | Genetic Techniques |
| D008745 | Methylation |
| D000478 | Alkylation |
| D001669 | Biochemical Phenomena |
| D055598 | Chemical Phenomena |
| D008660 | Metabolism |
| D055614 | Genetic Phenomena |
| D007124 | Immunoenzyme Techniques |
| D007118 | Immunoassay |
| D007163 | Immunosorbent Techniques |
| D015336 | Molecular Probe Techniques |
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