Can a custom vaccine train the body to fight ovarian cancer?
NCT ID NCT00799110
First seen Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time
Summary
This phase 2 trial tests a personalized vaccine made from a patient's own immune cells fused with their tumor cells, given alongside GM-CSF injections and imiquimod cream. The goal is to see if this combination can trigger a stronger immune response against ovarian, fallopian tube, or primary peritoneal cancer. Researchers will also monitor side effects and any impact on the cancer itself.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A personalized vaccine made from a patient's own dendritic cells fused with their tumor cells, given with GM-CSF injections and imiquimod cream
- What this could lead to
- If it works, this approach could strengthen the immune system's ability to fight ovarian cancer and potentially slow or shrink the disease.
- What could go wrong
- This is a small, early-phase trial, so the vaccine may not produce a strong immune response or affect the cancer. Side effects from the vaccine or the immune boosters are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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15 people
The number who actually took part.
- Started
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May 2008
- Finished
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Sep 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion criteria at time of initial enrollment: * 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 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 Exclusion Criteria: * 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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
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Brigham & Women's Hospital
Boston, Massachusetts, 02115, United States
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Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Patient's own immune cells fight ovarian cancer?
- Ovarian Cancer's spread: scientists probe abdominal fluid for clues
- New PET tracer aims to light up hidden cancer targets
- Can inhaled manganese make ovarian cancer immunotherapy hit harder?
- Can a pill shrink Hard-to-Treat ovarian tumors?
- New antibody aims to preserve immune checkpoint while fighting cancer