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AzTrials

Ovarian CancerPhase 2NCT00703105

Ovarian Dendritic Cell Vaccine Trial

A Phase 2 study testing DC vaccination in people with Ovarian Cancer, run by Loyola University at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
DC vaccination
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteUnited States
Study dates
Oct 2008to Jul 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • 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 the vaccine 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 -CLOSED) 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. Vaccine 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

Tina Porubsky, RN contact

708-327-2831

tporubsky@luc.edu

United States1 site, 1 recruiting

  • Loyola Univeristy Medical Center, Cardinal Bernardin Cancer Center

    Maywood, Illinois, 60153

    Cheryl Czerlanis, MD

    Ronald Potkul, MD

    Recruiting

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Ovarian Cancer
Being tested
DC vaccination
Keywords
ovarian cancer, Tregs, vaccine, Recurrent Ovarian Cancer
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DC vaccinationBiological

    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)

Study groups in NCT00703105
Study groupRoleWhat they receive
Autologous Dendritic Cell VaccinationExperimentalDC 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)
Receives: Biological: DC vaccination

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: days 45 and 62 post vaccine

Secondary outcomes (1)

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

    CTAE4 toxicities

    Measured: weekly assessments for a total of 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2008 (estimated)
  2. Study startOct 2008
  3. Primary completionJul 2021 (estimated)
  4. Study completionJul 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00703105
Sponsor's protocol ID
200541
Status last verified
Apr 2021
First submitted
19 Jun 2008
Last updated
26 Apr 2021
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DC vaccination in people with Ovarian Cancer, run by Loyola University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Tina Porubsky, RN (708-327-2831, tporubsky@luc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00703105.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2021.

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