NCT01673217

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

A Phase I Clinical Trial of NY-ESO-1 Protein Immunization in Combination With 5-AZA-2'-Deoxycytidine (Decitabine) in Patients Receiving Liposomal Doxorubicin for Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

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.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2009-04-01
• Primary completion: 2011-10-01
• Completion: 2013-06-01
• First posted: 2012-08-27
• Last updated: 2022-08-01

Locations

1 site across 1 country: United States