Neoplasms

All Conditions

Nervous System Diseases

Rare Diseases

Glioma

Glioblastoma

Brain Neoplasms

Astrocytoma

Oligodendroglioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Anaplastic Astrocytoma

Anaplastic Oligodendroglioma

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Carboplatin

Irinotecan

Osimertinib

Everolimus

Temozolomide

Lomustine

Lapatinib

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

Patients with newly found supratentorial lesions, or patients previously diagnosed with supratentorial gliomas at time of recurrence, whose treatment plan includes partial or total resection surgery as a component of standard-of-care treatment will be included.

- Placement of 1-3 microdevices (depending on the size of the tumor) before tumor resection is started.

-- The microdevices will dwell in the tumor tissue for a time window of 2-4 hours to allow time for tissue effects of the drugs microdoses for intratumor release of the following 8 approved drugs: Temozolomide, Lomustine, Irinotecan, Carboplatin, Lapatinib, Osimertinib, Abenaciclib, and Everolimus. The drugs used in this study will only include drugs already used systemically for the treatment of gliomas.

Placement of 1-3 microdevices (depending on the size of the tumor) before tumor resection is started.

The microdevices will dwell in the tumor tissue for a time window of 2-4 hours to allow time for tissue effects of the drugs (Temozolomide, Lomustine, Irinotecan, Carboplatin, Lapatinib, Osimertinib, Abenaciclib, and Everolimus) released by the microdevice reservoirs. The drugs used in this study will only include drugs already used systemically for the treatment of gliomas.

Microdevice

Pier Paolo Peruzzi, MD, PhD

This pilot study will assess the safety and feasibility of using an implantable microdevice to measure local intratumor response to chemotherapy and other clinically relevant drugs in malignant brain tumors.

* The device involved in this study is called a microdevice.
* The drugs used in this study will only include drugs already used systemically for the treatment of gliomas.

This research study is a Pilot Study, which is the first time investigators are examining this study device in brain tumors.

The FDA (the U.S. Food and Drug Administration) has not approved the microdevice as a treatment for any disease.

Investigators are studying the safety of the microdevice and the effects of different drugs for each specific tumor. Brain tumors are known to be very different from each other and respond differently to different drugs. It would be very helpful to find out what drugs have the best chance of working in each specific tumor.

This research study involves drugs that are released by a small device, as small as the tip of a needle, that is inserted into the tumor at the time of surgery and is removed at the end of the surgery. The goal of this research study is to prove that microdevices can be used to find out which drugs have better effects on treating malignant brain tumors.

Participants will be in this research study for up to 30 days.

Expected enrollment is about 12 people.

Implantable Microdevice In Primary Brain Tumors

A Pilot Study of an Implantable Microdevice for In Situ Evaluation of Drug Response in Patients With Primary Brain Tumors

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.

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.

Failure" from a safety standpoint will be considered any of the following:

* Any grade 3 or higher adverse events associated with microdevice placement or retrieval.
* Any combination of more than two grade 2 adverse events.

Failure" from a safety standpoint will be considered any of the following:

two-tailed alpha level of 0.05 and report 95% confidence intervals with any point estimates

Preliminary correlations between a specific genetic feature and drug response will be tested using the Chi-squared/Fisher's exact test for categorical variables or the T-test or Wilcoxon Rank-Sum test for continuous variables.

Oliver Jonas, PhD

Sponsor Investigator

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Digestive System 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

Fallopian Tube Diseases

Abdominal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Peritoneal Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Antirheumatic Agents

Gemcitabine

Paclitaxel

Albumin-Bound Paclitaxel

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)

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

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

The intervention to be administered is the placement of the microdevice containing 19 FDA-approved drugs into the lung lesion and the device's subsequent surgical resection. All study subjects will receive this same intervention; there is only one arm.

The microdevice containing 19 FDA-approved chemotherapeutic agents will be placed in the suspected tumor tissue at the time of surgical resection. Multiple chemotherapeutic agents will passively diffuse into local, confined regions (several microns) of the surrounding microenvironment. The agents are released at approximately one millionth of a systemic dose. The device(s) will be removed for analysis at the time of resection, which will be performed for clinical indications independent of enrollment in this study.

Microdevice loaded with 19 chemotherapeutic agents

Yolonda L Colson, MD, PhD

This is a pilot study for placement of a tiny microdevice into lung tumors to more precisely predict tumor-specific drug sensitivity, and to help inform systemic therapeutic decisions. The microdevice will provide a novel technique for interrogating human lung tumor tissue in situ, and will uniquely facilitate assessment of response to multiple drugs simultaneously. This will not only increase the specificity of a particular participant's chosen systemic therapy, it will also augment the speed and efficiency with which investigators are able to make clinical decisions regarding choice of therapy.

The initial aims in this pilot study will focus on the safety and feasibility of microdevice placement and retrieval in participants with suspicious lung lesions. The microdevice, which is 5.5 mm in length and approximately 750 µm in diameter (i.e., comparable in size and shape to commonly used fiducial markers), will be placed in the suspected tumor tissue at the time of surgical resection. Multiple agents will passively diffuse into local, confined regions (several microns) of the surrounding microenvironment. The agents are released at approximately one millionth of a systemic dose. The device(s) will be removed for analysis at the time of resection, which will be performed for clinical indications independent of enrollment in this study. The investigators will collect data regarding the safety and feasibility of the placement and retrieval of the microdevices, and perform detailed tissue analysis of drug response. Investigators hope to compile preliminary data regarding correlations between in situ drug response and the genetic and histopathologic features of tumors, systemic treatment response, and ultimately, clinical outcomes.

Microdevice for Evaluating Drug Response in Site in Lung Lesions

Pilot Study of Microdevice for Evaluating Drug Response in Site in Lung Lesions

Safety will be measured quantitatively by the number of participants with treatment-related adverse events.

Feasibility will be based on the ability to retrieve the device with sufficient tissue, of sufficient quality, for downstream histopathology analysis and interpretation of the device reservoirs.

This initial proof-of-concept pilot study will gauge the ability of using the microdevice to predict tumor drug response, allowing a stratified systemic treatment to prioritize those agents inducing the greatest anti-tumor response.

Massachusetts General Hospital

Oliver Jonas

Co-Investigator, Division of Radiology

Prostatic Neoplasms

Genital Neoplasms, Male

Genital Diseases, Male

Prostatic Diseases

Male Urogenital Diseases

Pembrolizumab

Docetaxel

Ipilimumab

Participant eligibility for intervention and selection of lesion for device placement

- Surgery Cohort will undergo percutaneous placement of several microdevices in a selected tumor(s) prior to surgery. The microdevice in the surgery cohort will dwell in the tumor tissue for approximately 48 hours to allow time for tissue effects of the drugs in the microdevice reservoirs.

Placement of at least 1, and up to 6, microdevices depending on the number of lesions, size and accessibility

* Extirpative surgery will proceed according to standard-of-care procedures. The microdevice(s) will be removed surgically along with surrounding tumor tissue.
* Standard of care treatment and follow-up of clinical course

Each participant will undergo a screening process to determine their eligibility for microdevice placement, consisting of the following items:

* Routine standard of care for radical prostatectomy.
* Placement of implantable microdevice with multiple miniature drug reservoirs but no drug in prostate that have been removed
* Ex vivo image guided removal using retrieval device
* Standard of Care Treatment and follow-up of clinical course

Surgery Cohort: Placement of 1-6 microdevices: Drugs chosen have all been FDA approved for the treatment of cancer (so therefore safe) and there are phase 2 or 3 data that the drug has efficacy in prostate cancer. Agents of interest included Abiraterone, Enzalutamide, Pembrolizumab, Ipilimumab, Carboplatin, Docetaxel, and Olaparib as well as combinations

Ex vivo Cohort: Placement of multiple microdevices with miniature drug reservoirs but no drug is loaded into the removed prostate

Adam S Kibel, MD

In this research study, is assessing the feasibility of using an MR-guided implantable microdevice to measure tumor response to chemotherapy and other clinically relevant drugs in participants that have prostate cancer and are scheduled for a radical prostatectomy.

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

- Implantation of a MR-guided microdevice

This research study is assessing the feasibility and safety of implanting and retrieving a 'microdevice' that releases up to 20 drugs directly within the prostate cancer lesion as a possible tool to evaluate the effectiveness of several approved cancer drugs against prostate cancer.

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

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

* Implantation of a MR-guided microdevice .
* It is expected that about 35 people will take part in this research study; 5 in the Ex Vivo Cohort and 30 in Surgery Cohort.

  * Ex Vivo Cohort will undergo placement of microdevice in the prostate after its surgical removal.
  * Surgery Cohort will undergo percutaneous placement of several microdevices in a selected tumor prior to surgery.

This research study is a Pilot Study, which is the first-time investigators are examining this study intervention. The FDA (the U.S. Food and Drug Administration) has not approved the implantation of the microdevice for this specific disease, but usage of this has been approved for other uses.

Pilot Study of an Implantable Microdevice for Evaluating Drug Responses in Situ in Prostate Cancer

Safety of microdevice placement and removal based on assessment of adverse events

* Feasibility of microdevice placement based on the ability in the Surgical Cohort to percutaneously place and surgically retrieve the device with sufficient tissue, of sufficient quality, for downstream histopathology analysis and interpretation.
* In the Surgical Cohort, if not more than 1 IMD per patient fails to be percutaneously placed and surgically retrieved with sufficient tissue of sufficient quality for downstream histopathology analysis and interpretation, we would consider this procedure to be a success. If at least 23/30 Surgical Cohort patients have successful procedures, as previously defined, we would consider this approach feasible. The 90% CI for 23 out of 30 successes is (60.6%, 88.5%) and thus excluding a 60% success rate which is considered as too low.

measure local intratumor response to clinically relevant cytotoxic agents and small molecule drugs in prostate cancers using quantitative histopathologic assessment of tumor tissue.

All inferences of secondary endpoints will use two-sided alpha = 0.05 and report 95% confidence intervals with any point estimates. Descriptive statistics will be used to summarize the quantitative measurements of apoptosis, proliferation, DNA repair, etc. for drug-treated regions compared to vehicle-treated regions. At least two separate regions will contain vehicle to account for tumor heterogeneity.

comparing the extent of tumor response to drug among different locations in a single tumor with multiple microdevice.

All inferences of secondary endpoints will use two-sided alpha = 0.05 and report 95% confidence intervals with any point estimates.

immune infiltrates, in the local tumor tissue adjacent to the microdevice, and to perform a preliminary assessment of the correlation between these features and extent of tumor response with the microdevice All inferences of secondary endpoints will use two-sided alpha = 0.05 and report 95% confidence intervals with any point estimates.

To determine the genetic features of the tumor tissue adjacent to the microdevice (e.g. whole exome sequencing, whole transcriptome sequencing) and to perform a preliminary assessment of the correlation between known genetic markers of drug sensitivity or resistance and extent of tumor response with the microdevice Genetic alterations will be catalogued in terms of single nucleotide variants, insertions/deletions, and copy number changes and will be primarily reported in a descriptive manner. Preliminary correlations between a specific genetic feature and specific clinical features will be tested using the Chi-squared/Fisher's exact test for categorical variables or the T-test or Wilcoxon Rank-Sum test for continuous variables

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Implantable Microdevice In Primary Brain Tumors	NCT04135807	Grade II Glioma Grade III Gliom... Grade IV Glioma Astrocytoma Oligodendroglio... Anaplastic Astr... Anaplastic Olig... Glioblastoma	Microdevice	18 Years -	Dana-Farber Cancer Institute
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
Microdevice for Evaluating Drug Response in Site in Lung Lesions	NCT03972228	Lung Tumor Lung Cancer	Microdevice loa...	18 Years -	Brigham and Women's Hospital
Microdevice for Evaluating Drug Response in Site in Lung Lesions	NCT03972228	Lung Tumor Lung Cancer	Microdevice loa...	18 Years -	Brigham and Women's Hospital
Pilot Study of an Implantable Microdevice for Evaluating Drug Responses in Situ in Prostate Cancer	NCT04399876	Prostate Cancer Radical Prostat...	Microdevice	22 Years -	Brigham and Women's Hospital

Spots Global Cancer Trial Database for microdevice

Every month we try and update this database with for microdevice cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for microdevice

Every month we try and update this database with for microdevice cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for microdevice cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.