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Can a custom vaccine train the body to fight ovarian cancer?

NCT ID NCT00799110

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

15 people

The number who actually took part.

Started

May 2008

Finished

Sep 2025

Lead sponsor

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

18 years and older

Sex

Female participants only

Healthy volunteers

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

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

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Brigham & Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.