Know Cancer

or
forgot password

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


Phase 1
18 Years
N/A
Not Enrolling
Female
Recurrent Fallopian Tube Cancer, Recurrent Ovarian Epithelial Cancer, Recurrent Primary Peritoneal Cavity Cancer

Thank you

Trial Information

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


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.


Inclusion Criteria:



- Subjects with relapsed epithelial ovarian cancer (including fallopian tube and
primary peritoneal cancer) who will receive liposomal doxorubicin as salvage therapy
for recurrent disease

- 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:

- Metastatic disease to the central nervous system for which other therapeutic options,
including radiotherapy, may be available

- 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicity as assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0

Outcome Description:

Estimated with a one-sided, 95%, Wilson score binomial confidence interval.

Outcome Time Frame:

Up to 6 months

Safety Issue:

Yes

Principal Investigator

Kunle Odunsi

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

I 127008

NCT ID:

NCT01673217

Start Date:

April 2009

Completion Date:

June 2013

Related Keywords:

  • Recurrent Fallopian Tube Cancer
  • Recurrent Ovarian Epithelial Cancer
  • Recurrent Primary Peritoneal Cavity Cancer
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Glandular and Epithelial
  • Ovarian Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263