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

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Roswell Park Cancer Institute
• Collaborators: Eisai Inc.; National Cancer Institute (NCI)
• Treatments: Azacitidine; Decitabine; Doxorubicin; Freund's Adjuvant; Liposomal doxorubicin; Sargramostim; Vaccines

Criteria

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