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Ovarian Dendritic Cell Vaccine Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00703105
Recruitment Status : Recruiting
First Posted : June 23, 2008
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
Patrick Stiff, Loyola University

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.


Condition or disease Intervention/treatment Phase
Ovarian Cancer Biological: DC vaccination Phase 2

Detailed Description:
Patients with advanced ovarian carcinoma who have failed initial curative chemotherapy attempts will be evaluated at the time of relapse for tumor debulking surgery prior to the initiation of salvage chemotherapy. If appropriate, samples will be collected for tumor lysate preparation for vaccination as per the existing Loyola protocol. Lysates may also be produced by the collection of malignant effusions as performed for palliation of symptoms. Patients will then receive palliative chemotherapy to a maximum tumor cytoreduction. Patients from whom sufficient tumor cells have been collected for DC-based vaccine production will undergo a leukapheresis for DC cell production. Once completed, these patients will receive a DC vaccination with 1 x 106 tumor lysate and KLH-loaded immature DCs into inguinal nodes identified by ultrasound guidance for a total of three injections at two week intervals; or for those who are HLA-A2 restricted with pharmaceutical grade MUC1 and WT1 tumor peptides.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Defining the Role of CD4+CD25+ Immunoregulatory T-cells in the Treatment of Patients With Advanced Ovarian Cancer Who Receive Dendritic Cell Based Vaccine Therapies
Study Start Date : October 2008
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
Experimental: Autologous Dendritic Cell Vaccination
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
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)




Primary Outcome Measures :
  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 [ Time Frame: days 45 and 62 post vaccine ]
    response rate


Secondary Outcome Measures :
  1. To characterize the toxicities of this novel DC-based vaccination strategy. [ Time Frame: weekly assessments for a total of 4 weeks ]
    CTAE4 toxicities



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have a histologic or cytologic diagnosis of epithelial ovarian cancer
  • Patients are eligible if they have failed to enter a complete remission with induction therapy or have relapsed after a period of remission 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 Ontak in combination with 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 dose of Ontak

    • 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 dose of Ontak:

    • total bilirubin ≤ 2.0 mg/dl
    • AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal
    • creatinine ≤2.0 mg/dl
    • prothrombin time (INR) ≤1.5 X institutional upper limit of normal
    • albumin >3.0 mg/dl
  • If patients have had recent surgery, then they must be fully recovered from the effects of that surgery.
  • The effects of Ontak on the developing human fetus at the recommended therapeutic dose are unknown. Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Patients must have the ability to understand and the willingness to sign a written informed consent document.

Additional eligibility requirements for vaccine therapy initiation:

  • Patients are eligible after tumor collection for the vaccine strategy, or for those selected to receive ONTAK alone (group 3) because tumor is not available can enroll at ay time they fulfill the Eligibility Criteria. Pre-vaccination the goal is to establish a Minimal Residual Disease state (MRD maximum tumor diameter of any residual disease ≤ 1cm). This can be achieved with surgery and/or salvage chemotherapy. Ontak administration and/or vaccine therapy will commence at least 4 weeks after the completion of the last day of any of the aforementioned therapies
  • Patients to be randomized to groups 1 and 2 must have tumor available for preparation of tumor lysate vaccine
  • Women and members of all races and ethnic groups are eligible for this trial

Exclusion Criteria:

  • 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 Ontak. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00703105


Contacts
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Contact: Sandra Zakrzewski, RN 708-327-2831 SZAKRZE@lumc.edu

Locations
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United States, Illinois
Loyola Univeristy Medical Center, Cardinal Bernardin Cancer Center Recruiting
Maywood, Illinois, United States, 60153
Sub-Investigator: Cheryl Czerlanis, MD         
Sub-Investigator: Ronald Potkul, MD         
Sub-Investigator: Amir Elmishad, MD         
Sponsors and Collaborators
Loyola University
Investigators
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Principal Investigator: Patrick Stiff, MD Loyola University
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Responsible Party: Patrick Stiff, Professor of Medicine, Director, Cardinal Bernardin Cancer Center, Loyola University
ClinicalTrials.gov Identifier: NCT00703105    
Other Study ID Numbers: 200541
First Posted: June 23, 2008    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019
Keywords provided by Patrick Stiff, Loyola University:
ovarian cancer
Tregs
vaccine
Recurrent Ovarian Cancer
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Vaccines
Immunologic Factors
Physiological Effects of Drugs