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

Complete title: A Phase I Trial of the Safety and Immunogenicity of a DNA Plasmid Based Vaccine Encoding the Amino Acids 1-163 of Insulin-Like Growth Factor Binding Protein-2 (IGFBP-2) in Patients with Advanced Ovarian Cancer

Research Study Number       7396
    
Principal Investigator       Nora Disis, MD
    
Phase       I

Look up trial at NIH

Research Study Description

PRIMARY OBJECTIVES:

-To determine the safety of an IGFBP-2 Th polyepitope plasmid based vaccine in patients with advanced stage or recurrent ovarian cancer.

-To determine the immunogenicity of IGFBP-2 Th polyepitope plasmid based vaccine in patients with advanced stage or recurrent ovarian cancer.

Eligibility Criteria (must meet the following to participate in this study)

- Patients must be at least 18 years of age

- Patients with advanced stage (III/IV) or recurrent ovarian cancer, who have been treated to complete remission with standard therapies including primary debulking surgery.

- A CA-125 level within normal limits for the testing laboratory must be documented within 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/mm3

- Hemoglobin (Hgb) >= 10 mg/dl

- 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

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

- 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

- 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

Other exclusion criteria may apply.



Research Study Number       7396
    
Contact       Tumor Vaccine Group, Study Line
    
Telephone       206/543-6620
    
   

Keywords
Gynecological Cancer; Ovarian Cancer; Solid Tumors; Primary Peritoneal Cancer (PPC)

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