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Ovarian CancerPhase 2NCT00799110

Vaccination of Patients With Ovarian Cancer With Dendritic Cell/Tumor Fusions With Granulocyte Macrophage Colony-stimulating Factor (GM-CSF) and Imiquimod

A Phase 2 study testing GM-CSF, Dendritic Cell/Tumor Fusion Vaccine and imiquimod in people with Ovarian Cancer and Primary Peritoneal Cancer, run by Beth Israel Deaconess Medical Center at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This research study is evaluating the effect (good and bad) of a dendritic cell/tumor fusion vaccine in combination with the laboratory made agents GM-CSF and imiquimod on the participants immune system. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
GM-CSF, Dendritic Cell/Tumor Fusion Vaccine and imiquimod
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
4 sitesUnited States
Study dates
May 2008to Sep 2025
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 undergone therapeutic debulking surgery for independent clinical indications and have tissue frozen and stored under sterile conditions as part of protocol 07-319 (Study of Primary Tumor Harvest for the Purpose of Possible Use in a Future Clinical Trial in Patients with Ovarian, Fallopian Tube, or Primary Peritoneal Cancer)
  • Patients with histologically proven stage III or IV ovarian, fallopian tube or primary peritoneal serous carcinoma (or patients of any stage with recurrent disease) who demonstrate lack of disease progression as determined by clinical assessment as well as CA-125 levels and/or radiographic assessment
  • Patients must have ECOG performance status of 0-2 with greater than six week life expectancy.
  • All patients must be informed of the investigational nature of this study and must give written informed consent in accordance with institutional and federal guidelines.
  • Laboratories:WBC > 2.0 X 103/uL, Platelets > 50,000/uL, Bilirubin < 2.0 mg/dL, Creatinine <2.0 mg/dL, AST/ALT < 2.5 x ULN
  • Eligibility criteria prior to first vaccination
Show all 12Show fewer
  • At a maximum of twelve weeks after the last dose of chemotherapy, patients must fulfill the following criteria:
  • Complete clinical response after first-line chemotherapy for newly-diagnosed patients, or after second-line chemotherapy for relapsed patients who require secondary cytoreduction.**
  • Asymptomatic, low volume disease not requiring further chemotherapy prior to initiating vaccination
  • Complete clinical response is defined as normal exam, normal CT scan, and normal CA-125 level. Tumor tissue for relapsed patients would be obtained under informed consent at the time of a secondary surgical debulking, which would be performed as part of standard relapse management in appropriate patients.
  • Resolution of all chemotherapy related grade III-IV toxicity
  • Laboratories:WBC > 2.0 X 103/uL, Platelets > 50,000/uL, Bilirubin < 2.0 mg/dL Creatinine <2.0 mg/dL, AST/ALT < 2.5 x ULN

Who cannot join

  • Patient with progressive disease during first line chemotherapy with a platinum/taxane combination will be excluded.
  • Patients must not have clinically significant autoimmune disease that requires treatment with immunosuppressant medications.
  • Because of compromised cellular immunity and limited capacity to respond to vaccination, patients who are HIV+ will be excluded.
  • Patients must not have serious intercurrent illness such as infection requiring IV antibiotics, or significant cardiac disease characterized by significant arrhythmia, unstable ischemic coronary disease or congestive heart failure.
  • Pregnant and/or lactating women will be excluded. Premenopausal patients will undergo pregnancy testing when indicated. Women will practice effective birth control while receiving protocol treatment.
  • Patients with a history of clinically significant venous thromboembolism will be excluded.
  • Active second malignancy, aside from basal cell or squamous cell carcinoma of the skin (i.e. malignancy not treated with curative intent or diagnosis within the past 2 years)

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Brigham & Women's Hospital

    Boston, Massachusetts, 02115

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

Other trials in United States

About this study

Official title: Vaccination of Patients With Ovarian Cancer With Dendritic Cell/Tumor Fusions With GM-CSF and Imiquimod

This research study is evaluating the effect (good and bad) of a dendritic cell/tumor fusion vaccine in combination with the laboratory made agents GM-CSF and imiquimod on the participants immune system. Another purpose of this study is to determine the type and severity of any side effects associated with this new study vaccine. We will also be evaluating what effect the vaccine has on the participants cancer. Dendritic cell vaccines have already been tested in clinical trials involving participants with many different types of cancer. Dendritic cells are powerful immune-stimulating cells that are normally found in small amounts in the body and are responsible for immune responses against "foreign" substances that enter the body.

Read the detailed description
  • Patients must have undergone therapeutic debulking surgery for independent clinical indications and have tissue frozen and stored under sterile conditions as part of protocol 07-319 (Study of Primary Tumor Harvest for the Purpose of Possible Use in a Future Clinical Trial in Patients with Ovarian, Fallopian Tube, or Primary Peritoneal Cancer)
  • Participants will be assigned to one of two study groups. Both groups will undergo a procedure known as leukapheresis by which the white blood cells are removed from the participants blood in order to obtain the dendritic cells. Prior to this procedure participants may receive 4 injections of GM-CSF, which helps increase the white blood cell count.
  • If enough cells are obtained during the leukapheresis, tumor cells and dendritic cells will then be fused (mixed) together in the laboratory and divided into the appropriate doses for administration.
  • Participants assigned to Group 1 will undergo subcutaneous vaccination with the dendritic cell tumor fusion vaccine. On the day of the vaccine and three days afterwards, they will receive GM-CSF injections at the site of the vaccination. Participants will receive a dose of the vaccine every 3 weeks for a total of 3 vaccinations.
  • Participants assigned to Group 2 will undergo subcutaneous vaccination with the dendritic cell tumor fusion vaccine. On the day of the vaccine and three days afterwards, they will receive GM-CSF injection at the site of the vaccination. Additionally, imiquimod cream will be applied to the skin at the injection sight 2 hours before the vaccine administration. Participants will continue to apply imiquimod cream at the site of vaccination for 3 days following the injection. Participants will receive a dose of the vaccine every 3 weeks for a total of 3 vaccinations.
Being tested
GM-CSF, Dendritic Cell/Tumor Fusion Vaccine, imiquimod
Keywords
dendritic cells, fusion vaccines, GM-CSF, imiquimod
Medical subject headings
Ovarian Neoplasms, Fallopian Tube Neoplasms

What participants receive

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

  • GM-CSFDrug

    Injections given subcutaneously at the sight of vaccination on the day of the vaccination and for three days afterwards

  • Dendritic Cell/Tumor Fusion VaccineBiological

    Also called DC/tumor fusion vaccine

    Given subcutaneously once every three weeks for a total of three vaccines

  • imiquimodDrug

    Cream applied to the skin at the injection sight 2 hours before injection and for 3 days following the injection

Study groups in NCT00799110
Study groupRoleWhat they receive
Group 2ExperimentalVaccine, GM-CSF and imiquimod,
Receives: Drug: GM-CSF; Biological: Dendritic Cell/Tumor Fusion Vaccine; Drug: imiquimod
Group 1ExperimentalVaccination plus GM-CSF
Receives: Drug: GM-CSF; Biological: Dendritic Cell/Tumor Fusion Vaccine

What is being measured

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

  1. Determine if Cellular Immunity is Induced

    To determine if cellular immunity is induced by serial vaccination with DC/tumor fusion cells, when given with GM-CSF alone, or the combination of GM-CSF and imiquimod in this patient population.

    Measured: 2 years

Secondary outcomes (3)

  1. Toxicity Associated With Vaccination

    Toxicity associated with vaccination with DC/tumor fusion when given with GM-CSF.

    Measured: 2 years

  2. Clinical Response to Vaccination

    Clinical response to vaccination with DC/tumor fusion when given with GM-CSF.

    Measured: 2 years

  3. Immunologic Response Following Vaccination

    Immunologic response following vaccination with measures of patient cellular immune function and phenotypic characteristics of the vaccine preparation.

    Measured: 2 years

Timeline

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

  1. First posted27 Nov 2008 (estimated)
  2. Study startMay 2008
  3. Primary completionAug 2025
  4. Study completionSep 2025

Why it stopped: Withdrawal of funding

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00799110
Sponsor's protocol ID
07-380
Status last verified
Jul 2026
First submitted
26 Nov 2008
Last updated
5 Aug 2026
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GM-CSF, Dendritic Cell/Tumor Fusion Vaccine and imiquimod in people with Ovarian Cancer and Primary Peritoneal Cancer, run by Beth Israel Deaconess Medical Center at 4 sites 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 12 inclusion and 7 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: stopped early, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

Yes. Results are posted in the registry (first posted 5 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine if Cellular Immunity is Induced (time frame: 2 years). 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 NCT00799110.

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 5 Aug 2026.

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