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| Name | Class |
|---|---|
| Dana-Farber Cancer Institute | OTHER |
| Brigham and Women's Hospital | OTHER |
| Massachusetts General Hospital | OTHER |
| National Cancer Institute (NCI) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 2 | Experimental | Vaccine, GM-CSF and imiquimod, |
|
| Group 1 | Experimental | Vaccination plus GM-CSF |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GM-CSF | Drug | Injections given subcutaneously at the sight of vaccination on the day of the vaccination and for three days afterwards |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| To assess toxicity associated with vaccination with DC/tumor fusion when given with GM-CSF and imiquimod. | 2 years | |
| To assess clinical response to vaccination with DC/tumor fusion when given with GM-CSF and imiquimod. | 2 years |
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Inclusion criteria at time of initial enrollment:
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:
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| Name | Affiliation | Role |
|---|---|---|
| David Avigan, MD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Brigham & Women's Hospital |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 30, 2026 | |
| Reset | Apr 15, 2026 | |
| Release | Apr 17, 2026 |
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| NIH |
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| Dendritic Cell/Tumor Fusion Vaccine | Biological | Given subcutaneously once every three weeks for a total of three vaccines |
|
|
| imiquimod | Drug | Cream applied to the skin at the injection sight 2 hours before injection and for 3 days following the injection |
|
| To correlate immunologic response following vaccination with measures of patient cellular immune function and phenotypic characteristics of the vaccine preparation. | 2 years |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Reset | May 7, 2026 |
| Release | May 11, 2026 |
| Reset | Jun 4, 2026 |
| Release | Jun 11, 2026 |
| Reset | Jul 7, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 30, 2026 | Apr 15, 2026 | |||
| Apr 17, 2026 | May 7, 2026 | |||
| May 11, 2026 | Jun 4, 2026 | |||
| Jun 11, 2026 | Jul 7, 2026 |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
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| ID | Term |
|---|---|
| D016178 | Granulocyte-Macrophage Colony-Stimulating Factor |
| D000077271 | Imiquimod |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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