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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-02207 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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This pilot clinical trial studies auranofin in treating patients with epithelial ovarian, primary peritoneal, or fallopian tube cancer. Immunosuppressive therapy, such as auranofin, may be an effective treatment for epithelial ovarian, primary peritoneal, or fallopian tube cancer.
PRIMARY OBJECTIVES:
I. To demonstrate the feasibility of conducting a 10-patient pilot study in asymptomatic ovarian cancer patients with cancer antigen (CA 125) elevation.
SECONDARY OBJECTIVES:
I. To explore whether oral gold therapy either stabilizes or lowers the CA 125 level and maintains patients in an asymptomatic state and to provide descriptive data on tumor response and duration of response.
II. To acquire qualitative data on patients' perceptions of learning of CA 125 elevation.
III. To explore whether immunohistochemical staining for PKC iota expression in resected tumor samples appears to be associated with clinical outcomes with auranofin.
OUTLINE:
Patients receive auranofin orally (PO) twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6 months for 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (auranofin) | Experimental | Patients receive auranofin PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| auranofin | Drug | Given PO |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of conducting a 10-patient pilot study in asymptomatic ovarian cancer patients using CA 125 elevation | To demonstrate the feasibility of conducting a 10-patient pilot study in asymptomatic ovarian cancer patients with CA 125 elevation. This study could potentially serve as a paradigm to investigate agents that might eventually be used as maintenance therapy in patients at high risk for recurrent disease. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Immunohistochemical staining for PKCt expression in resected tumor samples with Auranofin | To explore whether immunohistochemical staining for PKCt expression in resected tumor samples appears to be associated with clinical outcomes with Auranofin. | up to 2 years |
| Patients' perceptions of learning of CA 125 elevation |
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Inclusion Criteria:
Exclusion Criteria:
Co-morbid systemic illnesses or other severe concurrent disease, which in the judgment of the treating oncologist, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
Symptoms (other than anxiety, depression, or other psychological symptoms) that, in the opinion, of the treating oncologist are a direct result of cancer recurrence; (examples of symptoms that would preclude enrollment include unintentional weight loss and new abdominal pain)
Receiving any other prescribed therapy treatment for ovarian cancer
Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:
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| Name | Affiliation | Role |
|---|---|---|
| Aminah Jatoi, M.D. | Mayo Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35254001 | Derived | Rousselle B, Massot A, Privat M, Dondaine L, Trommenschlager A, Bouyer F, Bayardon J, Ghiringhelli F, Bettaieb A, Goze C, Paul C, Malacea-Kabbara R, Bodio E. Conception and Evaluation of Fluorescent Phosphine-Gold Complexes: From Synthesis to in vivo Investigations. ChemMedChem. 2022 Jun 3;17(11):e202100773. doi: 10.1002/cmdc.202100773. Epub 2022 Mar 29. |
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| laboratory biomarker analysis | Other | Correlative studies |
|
| up to 2 years |
| Oral gold therapy influence on the CA 125 levels | To explore whether oral gold therapy either stabilizes or lowers the CA 125 level and maintains patients in an asymptomatic state and to provide descriptive data on tumor response and duration of response. | 2 years |
| ID | Term |
|---|---|
| D005185 | Fallopian Tube Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005184 | Fallopian Tube Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D010051 | Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| D001310 | Auranofin |
| ID | Term |
|---|---|
| D006051 | Aurothioglucose |
| D050607 | Organogold Compounds |
| D009942 | Organometallic Compounds |
| D009930 | Organic Chemicals |
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