RecruitingPhase 1NCT04701645

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

Sponsor

Brigham and Women's Hospital

Enrollment

20 participants

Start Date

Nov 1, 2022

Study Type

INTERVENTIONAL

Conditions

Ovarian Cancer Fallopian Tube Cancer Ovarian Cancer Stage III Ovarian Cancer Stage IV Peritoneal Cancer Fallopian Tube Cancer Stage IV Fallopian Tube Cancer Stage III

Summary

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

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing tiny implantable devices (microdevices) that can be placed directly into ovarian, fallopian tube, or peritoneal tumors to test how the cancer responds to multiple drugs at the same time — all without a full course of systemic chemotherapy. The goal is to find the most effective treatment for each individual patient. **You may be eligible if...** - You have suspected or confirmed advanced (stage III-IV) ovarian, fallopian tube, or peritoneal cancer - You are newly diagnosed, have relapsed disease, or are considering a different treatment approach - You are able to undergo a surgical or biopsy procedure **You may NOT be eligible if...** - You cannot safely undergo a procedure to place the device - You have conditions that prevent surgery or anesthesia - Final pathology does not confirm ovarian cancer (you would be removed from the study) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTMicrodevice

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)

Locations(2)

Brigham and Women's Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

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NCT04701645

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