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

University of Washington

Status and phase

Completed

Phase 1

Conditions

Stage IV Ovarian Germ Cell Tumor

Stage III Ovarian Epithelial Cancer

Stage IV Ovarian Epithelial Cancer

Stage III Ovarian Germ Cell Tumor

Treatments

Other: laboratory biomarker analysis

Biological: pUMVC3-hIGFBP-2 multi-epitope plasmid DNA vaccine

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01322802

7396 (Other Identifier)

RG7212000 (Other Identifier)

134

P30CA015704 (U.S. NIH Grant/Contract)

NCI-2011-00099 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

PRIMARY OBJECTIVES:

I. To determine the safety of an insulin like growth factor binding protein 2 (IGFBP-2) Th polyepitope plasmid based vaccine in patients with advanced stage or recurrent ovarian cancer.

SECONDARY OBJECTIVES:

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

II. To determine whether intermolecular epitope spreading occurs with the generation of an IGFBP-2 specific Th1 immune response.

III. To determine whether IGFBP-2 vaccination modulates T regulatory cells.

OUTLINE:

Patients receive pUMVC3-hIGFBP-2 multi-epitope plasmid DNA vaccine intradermally (ID) monthly for 3 months.

After completion of study treatment, patients are followed up at 1, 3, 6, and 12 months, and then every 6 months for 5 years.

Enrollment

25 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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