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

Symptoms and General Pathology

Recurrence

Disease Progression

Meningioma

Ependymoma

Bevacizumab

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Topoisomerase I Inhibitors

Enzyme Inhibitors

125 mg/m2 non-EIAED or 340 mg/m2 EIAED every 2 weeks

Ulrik Lassen, MD., PH.D.

Irinotecan has demonstrated activity in malignant gliomas in multiple phase II studies. The activity is limited, with an approximately 15 % response rate and a progression-free survival of 3-5 months. Given the synergy between irinotecan and bevacizumab in colorectal cancer, and the high-level expression of vascular endothelial growth factor on malignant gliomas, one would expect synergy between bevacizumab and irinotecan against gliomas.

Recent data form a small study of 32 patients from Duke University have achieved a response rate of 62% in patients with malignant gliomas. Most included patients had glioblastomas, but this regimen may also have activity in more rare primary malignant brain tumors. The investigators therefore plan to include other primary malignant brain tumors in this study, and the clinical activity will be correlated with biomarkers and PET results of metabolic activity and blood flow. This may result in information that can be used to individualize therapy in the future.

Bevacizumab and Irinotecan for Patients With Primary Brain Tumors and Progression After Standard Therapy

Rigshospitalet, Denmark

Ulrik Lassen

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
Bevacizumab and Irinotecan for Patients With Primary Brain Tumors and Progression After Standard Therapy	NCT00463203	Brain Neoplasms Glioma	Bevacizumab Irinotecan	18 Years -	Rigshospitalet, Denmark
Bevacizumab and Irinotecan for Patients With Primary Brain Tumors and Progression After Standard Therapy	NCT00463203	Brain Neoplasms Glioma	Bevacizumab Irinotecan	18 Years -	Rigshospitalet, Denmark

Spots Global Cancer Trial Database for grade ii glioma