Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Digestive System Diseases

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Fallopian Tube Neoplasms

Peritoneal Neoplasms

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Fallopian Tube Diseases

Abdominal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Peritoneal Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Gemcitabine

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Etoposide

Vinorelbine

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Niraparib

Pemetrexed

Topotecan

Cisplatin

Olaparib

Ifosfamide

Etoposide phosphate

Isophosphamide mustard

Rucaparib

Patients with a new or suspected diagnosis of ovarian cancer who are deemed surgical candidates for primary cytoreductive surgery (as per their surgical gynecologic oncologist) and who have not yet undergone surgery.

* Participants will undergo percutaneous placement of several microdevices in a selected tumor deposit prior to surgery.
* The microdevices will dwell in the tumor tissue for approximately 24 +/- 8 hours to allow time for tissue effects of the drugs in the microdevice reservoirs. Microdevices will then be removed by resection of the tumor mass during a previously planned, and clinically indicated, surgical procedure.

Patients with newly diagnosed ovarian cancers who are being considered for either primary surgery or neoadjuvant chemotherapy by their surgical gynecologic oncologist, and who require a laparoscopic procedure to determine their candidacy for surgery.

* Participants will undergo percutaneous placement of several microdevices in a selected tumor deposit prior to surgery.
* The microdevices will dwell in the tumor tissue for approximately 24 +/- 8 hours to allow time for tissue effects of the drugs in the microdevice reservoirs. Microdevices will then be removed by resection of the tumor mass during a previously planned, and clinically indicated, surgical procedure.

Patients with recurrent ovarian cancer who are candidates for secondary cytoreduction, e.g.to confirm diagnosis of recurrent ovarian cancer and/or remove oligometastatic lesions.

* Participants will undergo percutaneous placement of several microdevices in a selected tumor deposit prior to surgery.
* The microdevices will dwell in the tumor tissue for approximately 24 +/- 8 hours to allow time for tissue effects of the drugs in the microdevice reservoirs. Microdevices will then be removed by resection of the tumor mass during a previously planned, and clinically indicated, surgical procedure.

Patients with newly diagnosed ovarian cancers who have undergone neoadjuvant chemotherapy and are deemed surgical candidates for interval debulking surgery (as per their surgical gynecologic oncologist) and who have not yet undergone surgery.

* Participants will undergo percutaneous placement of several microdevices in a selected tumor deposit prior to surgery.
* The microdevices will dwell in the tumor tissue for approximately 24 +/- 8 hours to allow time for tissue effects of the drugs in the microdevice reservoirs. Microdevices will then be removed by resection of the tumor mass during a previously planned, and clinically indicated, surgical procedure.

Placement of 1 to 6 implantable microdevices with multiple miniature drug reservoirs into a tumor mass 24 +/- 8 hours prior to surgery. Drugs will be released over 24 (+/- 8) hours while the microdevice is in the tumor prior to retrieval. The local tissue is retrieved along with the microdevice and no residual drug will remain.

* Each microdevice will harbor up to 20 drugs and drug combinations relevant to the treatment of ovarian cancer.
* Each drug or drug combination will be released from a single, separate reservoir. At least two reservoirs will harbor a drug vehicle only.
* Drugs will include all or a subset of the following: Cisplatin, Carboplatin, Paclitaxel, Doxorubicin or pegylated liposomal doxorubicin (PLD), Cyclophosphamide, Etoposide, Gemcitabine, Ifosfamide, Pemetrexed, Topotecan, Vinorelbine, Olaparib, Niraparib, Rucaparib, Carboplatin + paclitaxel (combination), Carboplatin + doxorubicin (combination),Carboplatin + gemcitabine (combination)

Microdevice

Elizabeth Stover, MD, PhD

Madeline Polak, BS

This pilot study will assess the feasibility of using an implantable microdevice to measure local intratumor response to chemotherapy and other clinically relevant drugs in ovarian, fallopian tube, and primary peritoneal cancer.

The name of the study intervention involved in this study is:

-implantable microdevice

This research study will assess the feasibility of using an implantable microdevice to measure local intratumor response to chemotherapy and other clinically relevant drugs in ovarian, fallopian tube, and primary peritoneal cancer.

Participants with suspected or confirmed ovarian cancer whose treatment plan includes surgery as a component of standard-of-care treatment will be identified.

-The research study procedures include screening for eligibility and study treatment including evaluations and follow-up.

The name of the study intervention involved in this study is: implantable microdevice

* Participant will undergo percutaneous placement of several microdevices in a selected tumor deposit prior to surgery. The microdevices will dwell in the tumor tissue for approximately 24 +/- 8 hours to allow time for tissue effects of the drugs in the microdevice reservoirs. Microdevices will then be removed by resection of the tumor mass during a previously planned, and clinically indicated, surgical procedure.
* It is expected that about 20 people will take part in this research study.

This research study is a Pilot Study, which is the first time investigators are examining this microdevice. The FDA (the U.S. Food and Drug Administration) has not approved the microdevice as a tool to identify which cancer treatment is best for any disease.

Microdevice In Ovarian, Fallopian Tube, And Peritoneal Cancer

Pilot Study of an Implantable Microdevice for Evaluating Drug Responses in Situ in Ovarian, Fallopian Tube, and Peritoneal Cancer

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Response assessed via apoptotic index measured by immunohistochemistry.

Inferences will use two-sided alpha = 0.05 and report 95% confidence intervals with any point estimates.

Platinum response category is defined as follows for both initial and secondary platinum exposure: platinum refractory (progression within 2 months of platinum-based chemotherapy), platinum resistant (progression within 2-6 months of platinum-based chemotherapy), and platinum sensitive (progression within 6-12 months of platinum based chemotherapy).

For dichotomous/categorical tumor features and patient outcomes, we will use Fisher's exact test. For continuous variables we will use a two-sided t-test if the data is approximately normally distributed, and Wilcoxon rank sum test if otherwise.

Platinum-free interval is defined as the interval between the date of the last platinum dose and the date of relapse detection.

For dichotomous/categorical tumor features and patient outcomes, we will use Fisher's exact test. For continuous variables we will use a two-sided t-test if the data is approximately normally distributed, and Wilcoxon rank sum test if otherwise.

Progression defined using RECIST 1.1 criteria; progression-free survival measured in months.

For dichotomous/categorical tumor features and patient outcomes, we will use Fisher's exact test. For continuous variables we will use a two-sided t-test if the data is approximately normally distributed, and Wilcoxon rank sum test if otherwise.

Candidate biomarkers for chemotherapy and PARP inhibitor response in ovarian cancer include RAD51 focus formation, markers of DNA damage (e.g. gamma-H2AX), and immune infiltrates. Each biomarker will be evaluated by immunohistochemistry to generate a quantitative score for the number of marker-positive cells per number of cells analyzed. Descriptive statistics will be used to summarize the results for each biomarker across multiple microdevices and drugs.

Response will be assessed via apoptotic index measured by immunohistochemistry and will be compared among multiple microdevices implanted within a single tumor.

Genetic alterations will be catalogued in terms of single nucleotide variants, insertions/deletions, and copy number changes in individual genes in the tumor tissue. Each alteration will be scored as "present" or "absent" in a tumor. Descriptive statistics will be used to summarize the frequency of each genomic event across multiple microdevices and drugs.

Descriptive statistics will be used to evaluate the safety of microdevice placement and removal, including reporting the maximum grade AE by type and organ class with 95% binomial confidence intervals.

Defined as the ability to retrieve the microdevice with sufficient tissue, of sufficient quality, for downstream histopathology analysis and interpretation of at least 50% of the microdevice reservoirs. For purposes of this endpoint, feasibility will be assessed on a per-device basis rather than a per-patient basis, with each microdevice considered to be relatively independent in terms of placement, retrieval, and analysis.

National Cancer Institute (NCI)

Dana-Farber Cancer Institute

Principal Investigator

Skin and Connective Tissue Diseases

Immune System Diseases

Breast Neoplasms

Triple Negative Breast Neoplasms

Hypersensitivity

Breast Diseases

Skin Diseases

Taxane

Patients will have the microdevice implanted prior to breast surgery, in the absence of neoadjuvant chemotherapy

Patients will have the device placed and retrieved on a core biopsy the following day, then receive neoadjuvant chemotherapy prior to definitive breast surgery.

This device contains 16 reservoirs, each with a unique single agent or drug combination in microdose amounts of less than one millionth of a systemic patient dose. The device is implanted directly into the tumor during a biopsy procedure, and remains in situ for \~24 hours.

KIBUR MICRODEVICE

Conventional, standard of care neoadjuvant chemotherapy delivered irrespective of device readout

anthracycline and taxane based chemotherapy

Tiffany Traina, MD

The purpose of this study is to test the safety and feasibility of placing and removing a small device that contains anti-cancer drugs in a breast tumor of patients who plan on having breast surgery without treatment prior or patients who plan on receiving standard preoperative chemotherapy prior to their breast surgery. This device may be able to predict what types of treatment work best against an individual's breast cancer. With this device, the investigators hope to be able to personalize treatment choices based on an individual's type of breast cancer.

Implantable Microdevice for In Vivo Drug Sensitivity Testing in Patients With Early Stage, HER2-Positive or Triple Negative Breast Cancer

Pilot Trial of an Implantable Microdevice for In Vivo Drug Sensitivity Testing in Patients With Early Stage, HER2-Positive or Triple Negative Breast Cancer

If we are able to collect data from at least 6 out of the 12 patients, we will deem this study feasible to conduct in a larger cohort of patients.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Microdevice In Ovarian, Fallopian Tube, And Peritoneal Cancer	NCT04701645	Ovarian Cancer Fallopian Tube ... Peritoneal Canc... Ovarian Cancer ... Ovarian Cancer ... Fallopian Tube ... Fallopian Tube ...	Microdevice	18 Years -	Dana-Farber Cancer Institute
Implantable Microdevice for In Vivo Drug Sensitivity Testing in Patients With Early Stage, HER2-Positive or Triple Negative Breast Cancer	NCT02521363	Breast Cancer	KIBUR MICRODEVI... anthracycline a...	19 Years -	Memorial Sloan Kettering Cancer Center
Implantable Microdevice for In Vivo Drug Sensitivity Testing in Patients With Early Stage, HER2-Positive or Triple Negative Breast Cancer	NCT02521363	Breast Cancer	KIBUR MICRODEVI... anthracycline a...	19 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for implantable microdevice