Ovarian Dendritic Cell Vaccine Trial

NCT00703105 | Unknown Phase 2

• 1 other identifier: 200541
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if a dendritic cell vaccine made with autologous tumor lysate or for patients who are HLA-A2 with peptides of MUC1 and WT1 therapy will produce remissions in patients with advanced ovarian cancer. This research is being done because we want to find new therapies for treatment of relapsed or refractory (resistant to ordinary treatment) ovarian cancer. The use of vaccine therapy is research. A new experimental approach for treating refractory or relapsed ovarian cancer involves using the patients own immune system to kill the cancer cells. These immune cells are called monocytes and are harvested from blood. The process of Leukapheresis collects the monocytes called Dendritic Cells. This is usually a 3 hour process done in the comfort of a hospital bed in the apheresis lab, similar to giving blood for donation. Approximately 300cc's are collected during this process, the equivalent of about 10 ounces of blood. Once these dendritic cells are collected - a special laboratory grows and processes them into a vaccine using a patient's own tumor cells or for those with a specific HLA type (HLA-A2) with tumor peptides. This preparation is then given back to the patient hopefully to stimulate the immune system to kill cancer cells. This type of treatment is considered biological research.

Conditions

Ovarian Cancer

Keywords

ovarian cancer; Tregs; vaccine; Recurrent Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• To determine if administration of an autologous tumor lysate or tumor peptide-loaded dendritic cell vaccine enhances the immune response in patients with relapsed/refractory ovarian cancer

  response rate

  days 45 and 62 post vaccine

Secondary Outcomes (1)

• To characterize the toxicities of this novel DC-based vaccination strategy.

  weekly assessments for a total of 4 weeks

Study Arms (1)

Autologous Dendritic Cell Vaccination

EXPERIMENTAL

DC vaccination with 1 x 10(6th) tumor lysate or WT1 and MUC1 peptide and KLH-loaded immature DCs into inguinal nodes identified by ultrasound guidance for a total of three injections at two week intervals(6 weeks)

Biological: DC vaccination

Interventions

DC vaccination BIOLOGICAL

DC vaccination with 1 x 10(6th) tumor lysate or tumor peptides and KLH-loaded immature DCs into inguinal nodes identified by ultrasound guidance for a total of three injections at two week intervals; (6 weeks)

Autologous Dendritic Cell Vaccination

Eligibility Criteria

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

You may qualify if:

• Patients must have a histologic or cytologic diagnosis of epithelial ovarian cancer
• Patients are eligible if they have failed to enter a complete remission after therapy and are not eligible for otherwise curative therapy
• Patients must not have received any antineoplastic chemotherapy or immunotherapy for the four weeks preceding tumor excision; six weeks for nitrosoureas and mitomycin-C
• Patients must not have received irradiation for the four weeks prior to removal of the tumor and no previously irradiated tumor deposits may be used for tumor lysate in the development of the dendritic cell vaccine
• Age \>18 years. Because no dosing or adverse event data are currently available on the use of dendritic cell vaccination in patients \<18 years of age, children are excluded from this study but may be eligible for future pediatric phase 2 combination trials
• Life expectancy of greater than three months
• Karnofsky performance status must be \>70%; (see appendix A)
• Patients must have adequate baseline hematopoetic function as defined below. - The following labs must be drawn within four weeks of having the tumor harvested and/or receiving the vaccine
• total white blood cell count \> 2,500/mm3
• absolute neutrophil count \> 1,000/mm3
• absolute lymphocyte count \> 500/mm3
• platelet count \> 80,000/mm3
• Patients must have adequate baseline organ function as defined below. The following labs must be drawn within four weeks of having the tumor harvested and/or receiving the vaccine:
• total bilirubin ≤ 2.0 mg/dl
• AST(SGOT)/ALT(SGPT) \<2.5 X institutional upper limit of normal

You may not qualify if:

• Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
• Patients may not be receiving any other investigational agents.
• Patients who have received prior anti-tumor vaccines are ineligible
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to monocolonal antibodies from Murine sources
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, active bleeding, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled bronchospasm, hypertension, hyperglycemia, or hypercalcemia; or psychiatric illness/social situations that in the opinion of the investigators would compromise the patient's ability to tolerate this treatment or affect compliance
• Pregnant and lactating women are excluded from this study. Because there is an unknown but potential risk for adverse events in nursing infants, breastfeeding should be discontinued if the mother is treated with the vaccine. These potential risks may also apply to other agents used in this study
• Patients with HIV infection, AIDS, or hepatitis B surface antigen positivity, are excluded from this trial. Patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy
• History of corticosteroid use in the four weeks preceding entry onto the clinical trial, or the requirement for ongoing corticosteroid use during the study period
• Patients who are expected to require therapeutic anticoagulation during the trial period
• Patients with known brain metastases

Sponsors & Collaborators

• Loyola University: lead

Study Sites (1)

Loyola Univeristy Medical Center, Cardinal Bernardin Cancer Center

Maywood, Illinois, 60153, United States

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; 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

• Patrick Stiff, MD

  Loyola University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tina Porubsky, RN

CONTACT

708-327-2831; tporubsky@luc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Director, Cardinal Bernardin Cancer Center

Study Record Dates

• First Submitted: June 19, 2008
• First Posted: June 23, 2008
• Study Start: October 1, 2008
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: April 26, 2021

Record last verified: 2021-04

Locations

US (1)