Vaccine Therapy in Treating Patients With Stage III-IV or Recurrent Ovarian Cancer

Completed · Phase 1

Conditions studied: Stage III Ovarian Epithelial Cancer, Stage III Ovarian Germ Cell Tumor, Stage IV Ovarian Epithelial Cancer, Stage IV Ovarian Germ Cell Tumor

In brief

This phase I trial is studying the side effects of vaccine therapy in treating patients with stage III-IV or recurrent ovarian cancer. Vaccines made from deoxyribonucleic acid (DNA) may help the body build an effective immune response to kill tumor cells.

Key facts

Study ID

NCT01322802

Run by

University of Washington

People needed

25

Starts

2012-03-06

Expected to finish

2020-12-01

Last updated by the study team

2021-02-25

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patients with advanced stage (III/IV) or recurrent ovarian cancer who have been treated to complete remission with standard therapies including primary debulking surgery
• Cancer antigen 125 (CA-125) level within normal limits for the testing laboratory must be documented 90 days prior to enrollment when the assessment of CA-125 is applicable
• Patients must be at least 28 days post cytotoxic chemotherapy, and/or monoclonal antibody therapy, prior to enrollment
• Patients must be at least 28 days post systemic steroids prior to enrollment
• Patients must have Eastern Cooperative Oncology Group (ECOG) Performance Status Score of =< 2
• Patients must have recovered from major infections and/or surgical procedures, and in the opinion of the investigator, not have any significant active concurrent medical illnesses precluding protocol treatment
• Estimated life expectancy of more than 6 months
• White Blood Cell (WBC) >= 3000/mm\^3
• Hemoglobin (Hgb) >= 10 mg/dl
• Hematocrit (Hct) >= 28%
• Serum creatinine =< 2.0 mg/dl or creatinine clearance > 60 ml/min
• Total bilirubin =< 2.5 mg/dl
• Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) =< 3 times upper limit of normal (ULN)
• Blood glucose < 1.5 ULN

You may not qualify if…

• Patients with any of the following cardiac conditions: symptomatic restrictive cardiomyopathy; unstable angina within 4 months prior to enrollment; New York Heart Association functional class III-IV heart failure on active treatment; symptomatic pericardial effusion
• Uncontrolled diabetes
• Patients with any contraindication to receiving sargramostim (rhuGM-CSF) based products
• Ovarian cancer of a low malignant potential phenotype or clear cell histology
• Patients with any clinically significant autoimmune disease uncontrolled with treatment
• Patients who are currently receiving an anti-IGF-IR monoclonal antibody as part of their treatment regimen
• Patients who are simultaneously enrolled in any other treatment study
• All subjects able to bear children

Where it is running

• Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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