Clinical Trial Detail

Clinical Trials

Clinical Trial Detail

IGFBP-2 Vaccine and Combination Chemotherapy in Treating Patients With Stage III-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Undergoing Surgery

Complete title: A Phase II Study of Concurrent IGFBP-2 Vaccination and Neoadjuvant Chemotherapy to Increase the Rate of Pathologic Complete Response at the Time of Cytoreductive Surgery

Research Study Number 9760
Principal Investigator John Liao
Phase II

Research Study Description

This phase II trial studies how well pUMVC3-IGFBP2 plasmid deoxyribonucleic acid (DNA) vaccine (IGFBP-2 vaccine) and combination chemotherapy work in treating patients with stage III-IV ovarian, fallopian tube, or primary peritoneal cancer undergoing surgery. IGFBP-2 is a protein found in the blood and tumor cells of most who have been diagnosed with ovarian cancer. Too much IGFBP-2 has been associated with more invasive disease. Vaccines made from DNA may help the body build an effective immune response to kill tumor cells that express IGFBP-2. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving IGFBP-2 vaccine and combination chemotherapy may work better in treating patients with stage III-IV ovarian, fallopian tube, or primary peritoneal cancer undergoing surgery.

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

Ages Eligible for Study: 18 Years and older (Adult, Senior)

Sexes Eligible for Study: Female

- Patients with newly diagnosed advanced stage (III/IV) ovarian cancer (ovarian/fallopian tube/peritoneal cancer) who have been recommended to receive neoadjuvant carboplatin/paclitaxel chemotherapy with subsequent cytoreductive surgery

- 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 cells (WBC) >= 3000/mm^3 within 30 days of enrollment to study

- Hemoglobin (Hgb) >= 10 g/dl within 30 days of enrollment to study

- Hematocrit (Hct) >= 28% within 30 days of enrollment to study

- Serum creatinine =< 2.0 mg/dl or creatinine clearance > 60 ml/min within 30 days of enrollment to study

- Total bilirubin =< 2.5 mg/dl within 30 days of enrollment to study

- Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) =< 3 times upper limit of normal (ULN) within 30 days of enrollment to study

- Blood glucose <1.5 ULN within 30 days of enrollment to study

- All patients who are having sex that can lead to pregnancy must agree to contraception for the duration of the study

- Patients must be at least 18 years of age

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

- History of (non-infectious) pneumonitis that required steroids or current pneumonitis

- Patients with any contraindication to receiving rhuGM-CSF based products

- 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

- Patients who are pregnant or breastfeeding

Other exclusion criteria may apply.

Research Study Number 9760
Contact Doreen Higgins, RN
Telephone 206-616-9538

Keywords: Fallopian Cancer; Ovarian Cancer; Solid Tumors; Urogenital Neoplasms; Genital Neoplasms, Female; Endocrine Gland Neoplasms; Peritoneal Cancer; Adnexal Diseases; Immunotherapy; Digestive System Diseases

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Please remember:

  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.

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