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
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.
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.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|