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

NCT01322802 | Completed Phase 1

• 5 other identifiers: 7396NCI-2011-00099134P30CA015704RG7212000
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stage III Ovarian Epithelial Cancer; Stage III Ovarian Germ Cell Tumor; Stage IV Ovarian Epithelial Cancer; Stage IV Ovarian Germ Cell Tumor

Keywords

Ovarian Cancer; Vaccine; Stage III; Stage IV; Remission

Outcome Measures

Primary Outcomes (1)

• Safety as assessed per Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

  Demographic and background characteristics obtained at enrollment will be listed and summarized. The type and grade of toxicities noted during the immunization regimen will be summarized. All adverse events noted by the investigator will be tabulated according to the affected body system. Descriptive statistics will be used to summarize changes from baseline in clinical laboratory parameters.

  Up to 16 months

Secondary Outcomes (5)

• Immunogenicity, via cellular immune response and humoral immune response, as assessed by the generation of IGFBP-2 specific T cells and IgG antibodies

  Up to 16 months

• Epitope spreading with the generation of an IGFBP-2 Th1 immune response

  Up to 16 months

• Levels of regulatory T- cells (Tregs) over the course of immunization to detect modulation of Tregs with vaccination

  Up to 16 months

• Disease-free survival

  Up to 5 years

• Overall survival

  Up to 5 years

Study Arms (1)

Treatment (pUMVC3-hIGFBP-2 multi-epitope plasmid DNA vaccine)

EXPERIMENTAL

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

Biological: pUMVC3-hIGFBP-2 multi-epitope plasmid DNA vaccine; Other: laboratory biomarker analysis

Interventions

pUMVC3-hIGFBP-2 multi-epitope plasmid DNA vaccine BIOLOGICAL

Given ID

Treatment (pUMVC3-hIGFBP-2 multi-epitope plasmid DNA vaccine)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (pUMVC3-hIGFBP-2 multi-epitope plasmid DNA vaccine)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Washington: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial; Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Mary Disis

  Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2011
• First Posted: March 25, 2011
• Study Start: March 6, 2012
• Primary Completion: January 9, 2015
• Study Completion: December 1, 2020
• Last Updated: February 25, 2021

Record last verified: 2021-02

Locations

US (1)