Clinical trial NCT04701645: Microdevice In Ovarian, Fallopian Tube, And Peritoneal Cancer
Official title: Pilot Study of an Implantable Microdevice for Evaluating Drug Responses in Situ in Ovarian, Fallopian Tube, and Peritoneal Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Cancer
Ovarian Cancer Stage III
Ovarian Cancer Stage IV
Fallopian Tube Cancer Stage IV
Fallopian Tube Cancer Stage III
Keywords: Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Cancer
Implantable Microdevice
Ovarian Cancer Stage III
Ovarian Cancer Stage IV
Fallopian Tube Cancer Stage IV
Fallopian Tube Cancer Stage III
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Dana-Farber Cancer Institute
First posted: 2021-01-08
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Participants must have suspected or confirmed clinically advanced stage (III-IV, defined as disease outside of the pelvis) ovarian, fallopian tube, or peritoneal cancer. If a patient has suspected ovarian cancer but final histologic analysis does not show evidence of ovarian cancer, the patient will be removed from the study and replaced.
* Participants must meet one of the following clinical categories:

  * Cohort 1: 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.
  * Cohort 2: 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.
  * Cohort 3: 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.
  * Cohort 4: 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 must be 18 years of age or older.
* Patients must be deemed medically stable to undergo both percutaneous procedures and standard-of-care surgical procedures by their treating gynecologic oncologist and medical oncologist.
* Participants will undergo laboratory testing within 14 days\* prior to the microdevice placement.

  * Patients must have absolute neutrophil count ≥ 1,500/mcL
  * Platelets ≥ 75,000/mcL
  * PT (INR) \< 1.5
  * PTT \< 1.5x control
  * Women of childbearing potential must have negative pregnancy test (urine or serum) \*\*Cohort 4 patients should undergo laboratory testing within 7 days prior to the microdevice placement
* Participants must be evaluated by a surgical gynecologic oncologist who will determine the clinically appropriate treatment strategy (primary surgery or neoadjuvant chemotherapy) based on clinical history and extent of disease. The patient's surgical and/or medical gynecologic oncologist must also confirm the patient's medical fitness to undergo an additional biopsy procedure and the indicated surgical procedure. The patient must have a plan to undergo surgery for clinical purposes.
* The following criteria must be met:

  * Participants must have undergone an abdominal/pelvic CT scan that both assesses the extent of disease and identifies an area of tumor amenable to safe microdevice placement. CT scans with both oral and IV contrast media are preferred but not required.

CT scans performed at outside institutions are acceptable providing that the images are considered adequate to assess the stage of the disease and to assess the safety and feasibility of the placement of the microdevices and their retrieval during standard-of care surgery. CT scan must be completed within 4 weeks prior to the microdevice placement.

* Patient has sufficient volume of disease as measured by CT scan to allow implantation of the microdevice.
* Patient has sufficient volume of disease that removal of the lesion where the microdevice is placed will not potentially affect adequate tissue for diagnosis.
* A lesion can be selected where the microdevice is to be implanted that is

  * Amenable to percutaneous placement
  * Amenable to removal at the time of surgery or laparoscopy. If patient is undergoing laparoscopy, the lesion must be able to be removed using a laparoscopic approach in a manner that would not significantly alter the procedure or affect patient safety, per opinion of the surgical oncologist.

    * Patients must have the ability to understand and the willingness to sign a written informed consent document.
    * Patients must be willing to undergo research-related genetic sequencing (somatic and germline) and data management, including the deposition of de-identified genetic sequencing data in NIH central data repositories.

Exclusion Criteria:

* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit the safety of a biopsy and/or surgery.
* Pregnant women are excluded from this study because of the possible increased dose of radiation from imaging associated with the microdevice placement and the potential risk to the pregnancy of the biopsy/device placement in an abdominal lesion.
* Uncorrectable bleeding or coagulation disorder known to cause increased risk with surgical or percutaneous biopsy procedures.
* Significant risk factors (including, but not limited to, high risk of venous thrombosis, pulmonary embolism, stroke or myocardial infarction) precluding the safe cessation of anticoagulation medication as per SIR guidelines. (Patients taking low-dose aspirin only do not need to be excluded.)

Primary outcomes:
measure: Number of participants with adverse events as defined in the CTCAE v5.0
timeFrame: Up to 2 months
measure: Number of implanted microdevices successfully retrieved
timeFrame: Up to 32 hours
Secondary outcomes:
Other outcomes:
measure: Measure local intratumor response to different agents
timeFrame: Up to 32 hours
measure: Correlate extent of tumor response with platinum response category
timeFrame: Up to 3 years
measure: Correlate extent of tumor response with platinum-free interval
timeFrame: Up to 3 years
measure: Correlate extent of tumor response with progression-free survival
timeFrame: Up to 3 years
measure: Correlate extent of tumor response with exploratory biomarkers of drug response
timeFrame: Up to 32 hours
measure: Compare extent of tumor response to drug among multiple microdevices implanted within a single tumor
timeFrame: Up to 32 hours
measure: Correlate extent of tumor response with genetic features of the tumor tissue
timeFrame: Up to 32 hours
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Elizabeth Stover, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: