Decitabine, Vaccine Therapy, and Doxorubicin Hydrochloride Liposome in Treating Patients With Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
| Status: | Archived |
|---|---|
| Conditions: | Ovarian Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | April 2009 |
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
RATIONALE: Drugs used in chemotherapy, such as decitabine and doxorubicin hydrochloride
liposome, 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 may help the body
build an effective immune response to kill tumor cells. Giving chemotherapy together with
vaccine therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of decitabine when
given together with vaccine therapy and doxorubicin hydrochloride liposome in treating
patients with recurrent ovarian epithelial cancer, fallopian tube cancer, or primary
peritoneal cancer.
OBJECTIVES:
Primary
- Determine the safety of decitabine when administered in combination with NY-ESO-1
peptide vaccine (emulsified with incomplete Freund's adjuvant and sargramostim
[GM-CSF]) and pegylated liposomal doxorubicin hydrochloride in patients with recurrent
ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.
Secondary
- Evaluate NY-ESO-1-specific cellular and humoral immunity by determination of
NY-ESO-1-specific antibodies and CD8+ and CD4+ T cells in patients treated with this
regimen.
- Determine the impact of decitabine on NY-ESO-1-specific expression, NY-ESO-1-promoter
methylation, and global DNA methylation.
- Compare the time to progression in patients treated with this regimen vs patients
treated with standard therapy (historical studies).
OUTLINE: This is a dose-escalation study of decitabine.
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 with incomplete Freund's
adjuvant and sargramostim (GM-CSF) subcutaneously on day 15. Treatment repeats every 28 days
for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Blood samples are collected periodically to assess NY-ESO-1-specific cellular and humoral
immunity by measuring NY-ESO-1-specific antibodies by ELISA; NY-ESO-1-specific CD8+ and CD4+
T cells by IFNγ-release ELISPOT assays; and the frequency of CD4+ CD25+ FOXP3+ regulatory T
cells. Tumor tissue samples are collected periodically to assess NY-ESO-1 expression by
quantitative RT-PCR and IHC; NY-ESO-1 promoter DNA methylation by pyrosequencing; and global
genomic DNA methylation by liquid chromatography-mass spectrometry.
After completion of study therapy, patients are followed at 2 weeks and then at 6 months.
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