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Microdevice for Ovarian Cancer

Phase 1

Recruiting

Led By Elizabeth Stover, MD, PhD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Patients must have absolute neutrophil count ≥ 1,500/mcL, Platelets ≥ 75,000/mcL, PT (INR) < 1.5, PTT < 1.5x control, and 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.

Must not have

Uncorrectable bleeding or coagulation disorder known to cause increased risk with surgical or percutaneous biopsy procedures.

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is being conducted to assess the feasibility of using this device to measure local intratumor response to chemotherapy and other clinically relevant drugs in ovarian, fallopian tube, and primary peritoneal cancer.

Who is the study for?

This trial is for adults with advanced stage (III-IV) ovarian, fallopian tube, or peritoneal cancer. Candidates must be medically stable for procedures and willing to undergo genetic sequencing. They need a negative pregnancy test if of childbearing potential and cannot have uncontrolled illnesses or conditions that increase biopsy/surgery risks.

What is being tested?

The study tests an implantable microdevice's ability to measure the local tumor response to chemotherapy in patients with certain types of cancer. It aims to determine the feasibility of this technology in guiding personalized treatment strategies.

What are the potential side effects?

Potential side effects are not explicitly listed but may include complications from surgical procedures such as infection, bleeding, or reactions related to additional imaging required by the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I agree to have my genes tested and shared anonymously for research.

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Your blood counts need to be within a certain range, and women who can have children must have a negative pregnancy test. If you're in cohort 4, you need to have these tests within 7 days before the microdevice placement.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a bleeding or clotting disorder that makes surgery risky.

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I do not have any severe illnesses that would make surgery or biopsy unsafe.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of implanted microdevices successfully retrieved

Number of participants with adverse events as defined in the CTCAE v5.0

Other study objectives

Compare extent of tumor response to drug among multiple microdevices implanted within a single tumor

Correlate extent of tumor response with exploratory biomarkers of drug response

Correlate extent of tumor response with genetic features of the tumor tissue

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Cohort 4: Interval debulking surgery following neoadjuvant chemotherapyExperimental Treatment1 Intervention

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.

Group II: Cohort 3: Secondary cytoreductionExperimental Treatment1 Intervention

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.

Group III: Cohort 2: Surgical assessment for primary surgeryExperimental Treatment1 Intervention

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.

Group IV: Cohort 1: Primary cytoreductionExperimental Treatment1 Intervention

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.

0 / 5Eligibility criteria met