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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-02151 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 20-013191 | Other Identifier | Mayo Clinic in Rochester |
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This study evaluates blood samples and compares levels of metabolites (levels of vitamins, carbohydrates, proteins, etc., that are in the blood), before and after the plasma exchange in patients scheduled to receive immunotherapy for their ovarian cancer. The information gained from this study may help researchers better understand the side effects from each treatment and possibly lessen those side effects for future treatments.
PRIMARY OBJECTIVE:
I. To determine the extent to which PARP inhibitor (PARPi) treatment reduces systemic levels of mesenchymal stem cell (MSC)-derived cancer support factors in patients with cancer.
OUTLINE:
Patients undergo collection of blood samples prior to drug initiation, weekly thereafter for the first month of therapy, monthly for the first month, and at disease progression or after cessation of treatment to monitor for toxicity. Blood samples are analyzed. Patients' medical charts are also reviewed to determine outcomes after PARP inhibition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ancillary-correlative (blood collection, chart review) | Patients undergo collection of blood samples prior to drug initiation, weekly thereafter for the first month of therapy, monthly for the first month, and at disease progression or after cessation of treatment to monitor for toxicity. Blood samples are analyzed. Patients' medical charts are also reviewed to determine outcomes after PARP inhibition. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo collection of blood samples |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of mesenchymal stem cell (MSC)-derived cancer support factors | Levels of MSC-derived cancer support factors will be compared to baseline (i.e. pre-PARPi therapy) at each collection time point by Student's t test. In addition, outcomes by Cox proportional hazards will be compared between designated responders (i.e. patients whose MSC-derived cancer support factors decreased after PARP inhibition) and non-responders (i.e. patients whose MSC-derived cancer support factors did not decrease after PARP inhibition) | At four weeks post PARP inhibitor treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Stratified by extent of MSC-derived cancer support factor reduction. Will also compare levels at progression and/or after discontinuation of therapy. | Up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with melanoma scheduled to receive immunotherapy for their ovarian cancer.
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| Name | Affiliation | Role |
|---|---|---|
| Jacob J. Orme, M.D., Ph.D. | Mayo Clinic in Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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Blood
| Laboratory Biomarker Analysis | Other | Ancillary studies |
|
| Medical Chart Review | Other | Review of medical charts |
|
|
| 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 |