Neoplasms

Symptoms and General Pathology

All Conditions

Nervous System Diseases

Neoplasm Metastasis

Brain Neoplasms

Neoplastic Processes

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

The study will be organised on three time-periods based on the time of the 1st CNS event:

Part A - Pre-diagnosis period: before diagnosis of the 1st CNS event Part B - At 1st CNS diagnosis period Part C - Post diagnosis period: after the 1st CNS event

At baseline

Part A:

* TNBC/ HER2+ BC: once a year
* NSCLC/SCLC: every 4 months
* Melanoma: every 6 months

Part B:

o As close as possible to the diagnosis of CNS metastases and no later than 6 weeks after diagnosis

Part C:

o Every 3 months (+/- 1 month)

Samples collection: Plasma

Part B: Mandatory CSF sampling at CNS diagnosis when clinically possible unless medically contra-indicated - As close as possible to the diagnosis of CNS metastases and no later than 6 weeks after diagnosis Part C: Additional CSF sampling in case CSF sampling is performed for routine clinical practice

Samples collection: CSF

Part B: Highly recommended non-CNS metastatic tumour tissue collection (1FFPE and 1 FT) at CNS metastases diagnosis (Part B) (NB: Bone lesions are excluded) - As close as possible to the diagnosis of CNS metastases and no later than 6 weeks after diagnosis

Samples collection: Non-CNS Metastatic Tumour Tissue

Part A:

* Brain MRI at inclusion is allowed within 45 days before enrolment
* Brain MRI pre-CNS diagnosis (Part A) : HER2 BC/TNBC: once a year; NSCLC/SCLC: every 4 months; Melanoma: every 6 months (+/- 1 month)

Part B:

o As close as possible to the diagnosis of CNS metastases and no later than 6 weeks after diagnosis

Part C:

o Brain MRI post-CNS diagnosis (Part C): every 3 months (+/- 1 month window)

Brain MRI

At baseline

Part A:

* TNBC/ HER2+ BC: once a year
* NSCLC/SCLC: every 4 months
* Melanoma: every 6 months

Part B:

o As close as possible to the diagnosis of CNS metastases and no later than 6 weeks after diagnosis for cohorts 1-5.

Samples collection: Serum

Nuria Kotecki

Diane Delaroche

Sylvie Bartholomeus

Andrea Gombos

Véronique Goblet

Florence Lefranc, MD

Nathalie Blondeel

François Duhoux

Veronique Petre

Jean-Luc Canon

Lore Vansteelant

Hannelore Denys

Malika Tahiri

Lore Decoster

Inge Wauters

Paul Clement, MD

Anna-Maria Barbuto

Stéphane Holbrechts

Dominique Crasson

Vincent Vanhaudenarde

Solene Charpentier

Claire Cheymol, MD

Anthony Lombardi

Anthony Goncalves, MD

Joseph Gligorov, MD

Imen Hafsi

Edith Borcoman, MD

Delphine Bridelance

Florian Clatot, MD

Sherine Anajar

Philippe Barthelemy, MD

Marina Basmaison

Eleonora De Maio Desposito, MD

Chouaib Mediouni

Caroline Duhem, MD

Nuria Kotecki, MD

Despite some encouraging data, systemic treatment of CNS metastases from solid tumors remains experimental.

Better knowledge on the evolving epidemiology and biology of BM are key elements for the development of new treatment strategies and identification of promising therapeutic targets for new compounds. Further biological findings may help to better understand the heterogeneity between the primary tumor and the CNS metastases and to identify new targets for therapy thus improving patients' outcome.

In this context, the Oncodistinct network and the Jules Bordet institute propose to build a multidisciplinary Brain Metastases Clinical Research Platform called BrainStorm. The BrainStorm program will focus on patients with newly diagnosed non-CNS metastatic solid tumors with high risk of developing CNS metastases and will allow building a large clinico pathological database for CNS metastases including ctDNA analyzes from CSF samples. Substudies will be proposed at each time-period with the final objective to develop innovative treatment approaches and strategies.

A Brain Metastases Research Platform to Tackle the Challenge of CNS Metastases in Solid Tumours

A Brain Metastases Research Platform to Tackle the Challenge of CNS Metastases in Solid Tumours - BrainStorm Program

To collect data regarding the biology of CNS metastases by investigating on :

* Time to the first CNS event
* Time to the second CNS event
* Time to whole brain radiotherapy (WBR)
* Time from the date of diagnosis of the first CNS event and the time of death by any cause

Levels of neuron specific enolase in blood

Deep targeted next-generation sequencing (NGS) on DNA samples from primary or non CNS metastases as well as germline DNA samples and CNS metastases if surgery. A set of 1-3 point mutations (single nucleotide variants) will be selected for each subject based on the above analyses for the identification and quantification of plasma ctDNA and CSF-ctDNA using deep targeted NGS. Subsequently targeted gene sequencing will be performed on DNA samples from CSF and plasma in case of at least 5% tumour mutant allele frequency (MAF) and CNS metastases in case of surgery.

To collect data regarding the epidemiology of CNS metastases from solid tumours and identify risk factors for CNS metastases development, including:

* Time to the first CNS event
* Time to the second CNS after first treatment and subsequent CNS events

To collect data regarding the epidemiology of CNS metastases from solid tumours and identify risk factors for CNS metastases development, including::

- Time to whole brain radiotherapy

To collect data regarding the epidemiology of CNS metastases from solid tumours and identify risk factors for CNS metastases development, including:

- Overall survival

To collect data regarding the biology of CNS metastases by investigating on:

- Presence of CSF-ctDNA at diagnosis of CNS metastases

To collect data regarding the biology of CNS metastases by investigating on:

- Presence of plasma ctDNA at diagnosis of CNS metastases

* quantification of plasma ctDNA and CSF-ctDNA using deep targeted NGS
* deep targeted next-generation sequencing (NGS) on DNA samples from primary or non-CNS metastases as well as germline DNA samples and CNS metastases if surgery

- A set of 1-3 point mutations (single nucleotide variants) will be selected for each subject based on the above analyses for the identification and quantification of plasma ctDNA and CSF-ctDNA using deep targeted NGS

- Standard analyses cytology and biochemistry analyses

- Quantitative measurement of serum neuron-specific enolase

La Fondation contre le cancer, Belgique

Les Amis de l'Institut Bordet

Bristol-Myers Squibb

Fondation Cancer, Luxembourg

Jules Bordet Institute

Patient pretreated for brain tumor and witness

Through this study, the investigators believe to describe more accurately the damage caused by brain radiation therapy in the long term.

Evaluation of Anatomy, Clinical and Neuropsychological Long-term Sequelae of Patients Treated With Radiation Therapy for Brain Tumor

To evaluate the proportion of patients with at least one abnormality on an imaging test

Centre Francois Baclesse

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Digestive System Diseases

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Uterine Cervical Neoplasms

Anus Neoplasms

Oropharyngeal Neoplasms

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Anus Diseases

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Anal Cancer

Camurati-Engelmann Disease

Antineoplastic Agents

All Drugs and Chemicals

Atezolizumab

Vaccines

Immunomodulating Agents

Human Papillomavirus Vaccine (HPV) vaccine at 1x10(11) Viral Particles (VP) Dose Level 1 (DL1) and at 5x10(11) VP Dose Level 2 (DL2)

Human Papillomavirus Vaccine (HPV) vaccine at recommended phase 2 dose (RP2D) plus M7824 at 1200 mg.

Human Papillomavirus Vaccine (HPV) vaccine at recommended phase 2 dose (RP2D) given as neoadjuvant or induction therapy.

Human Papillomavirus Vaccine (HPV) vaccine at recommended phase 2 dose (RP2D) plus M7824 at 1200 mg given as neoadjuvant or induction therapy.

On the phase I portion of the protocol PRGN-2009 will be administered on Day (D)1, D15, D29 followed by booster vaccines every 4 weeks for up to a year. The dose level given as booster will be the same dose participants will be receiving for D1, D15 and D29.

PRGN-2009 (Phase I)

On the phase II portion of the protocol PRGN-2009 will be administered on just Day (D)1 and D15.

PRGN-2009 (Phase II)

Subjects enrolled to Arm 1B will receive M7824 (MSB0011359C) via intravenous (IV) infusion over 1 hour (-10 minutes / +20 minutes, that is, over 50 to 80 minutes) once every 2 weeks. M7824 will be administered as a "flat" dose of 1,200 mg independent of body weight. M7824 is administered as an intravenous infusion with a mandatory 0.2 micron in-line filter.

M7824

MRI (with gadolinium) of the neck, chest, skull, and/or sinonasal, if indicated, will be used when computed tomography (CT) scan is not an option to follow the disease.

Bone scans and other imaging assessments may also be performed as clinically indicated.

Bone scan

Imaging of the neck, chest, skull, and/or sinonasal, if indicated, will be performed every 8 weeks. In the event of a partial response (PR) or complete response (CR) tumor imaging assessments may be performed every 3 months (+/- 2 weeks) at the discretion of the investigator.

CT scan

Performed at baseline and may also be performed as clinically indicated by development of new specific symptoms or on the discretion of the Principal Investigator.

Brain CT

Where feasible, optional biopsies may be done at baseline as well as at week 9 and will likely be computed tomography (CT) guided. If a recent (≤ 6 months preferred) outside biopsy has been performed that specimen may be used in lieu of a baseline biopsy for phase I participants.

For participants with lesions amenable to biopsy, two biopsies may be performed at baseline and at Week 9 (phase I participants).

Biopsy (Phase I)

Where feasible, biopsies will be done at baseline as well as at week 4-5. Biopsies will be done by ear, nose and throat (ENT) under direct visualization. Where feasible at least 2 cores will be obtained. If a recent (≤ 6 months preferred) outside biopsy has been performed that specimen may be used in lieu of a baseline biopsy.

For participants with lesions amenable to biopsy, two biopsies may be performed at baseline and at Week 4-5 (phase II participants).

Biopsy (Phase II)

Charalampos Floudas, M.D.

Background:

For some cancers associated with human papillomavirus (HPV), standard treatments are not helpful. Researchers want to see if a vaccine for HPV combined with a drug called M7824 (MSB0011359C) has a better effect on these cancers than when they work alone.

Objective:

To find a safe dose of HPV vaccine alone or combined with M7824. Also, to test if either HPV vaccine alone or combined with M7824 causes a better immune response.

Eligibility:

People ages 18 and older with locally advanced or metastatic HPV associated cancer (Phase I) or stage II or III p16-positive oropharyngeal cancer (Phase II)

Design:

Participants will be screened with:

Medical history

Physical exam

Blood, urine, and heart tests

Possible photos of skin lesions

Computed tomography (CT), magnetic resonance imaging (MRI), or nuclear bone scan: Participants will lie in a machine that takes pictures of the body. For the CT scan, they may have a contrast agent injected into a vein.

Participants may have up to 2 tumor biopsies. For participants in Phase II, this may be performed with a thin tube placed through the nose into the airway.

Participants will receive the HPV vaccine alone or with M7824. For participants on the Phase II, they will receive two doses of HPV vaccine under the skin either alone or with M7824 as an infusion spaced two weeks apart. This will be done prior to their planned chemoradiation or surgery. For participants on the Phase I, they will get the HPV vaccine injected under the skin 2 to 3 times in the first month. Then they will have a booster every 4 weeks. They will receive M7824 as an infusion into a vein every 2 weeks. Treatment will last up to 1 year.

After they stop treatment, participants will have a visit within 4 weeks. They will then be contacted for long-term follow-up every year, for the rest of their lives.

...

Background

* Metastatic human papillomavirus (HPV) associated malignancies (cervical, anal, oropharyngeal cancers, etc.) are often incurable and poorly palliated by standard therapies.
* HPV-positive (p16+) oropharyngeal cancers are the most common HPV-associated malignancy in the United States and are increasing in incidence.
* Stage II and III HPV-positive oropharyngeal cancer is primarily treated with definitive therapy.
* Although the prognosis for stage I HPV+ oropharyngeal cancer is favorable, about 20 percent of patients with stage II disease and 35 percent of patients with stage III disease will die within four years.
* Attempts to de-intensify treatment of HPV-positive oropharyngeal cancer by replacing high-dose cisplatin with cetuximab concurrent with radiotherapy have failed.
* Induction and neoadjuvant immunotherapy are an area of active study in this type of cancer. The aims of induction immunotherapy are to induce antigen-specific immunity prior to definitive therapy and to reduce the risk of disease relapse for patients with stage II and III disease.
* Therapeutic vaccines targeting HPV alone or in combination with M7824 (MSB0011359C) (dual programmed death-ligand 1 (PD-L1) and transforming growth factor beta (TGF- beta) inhibitor) have demonstrated induction of HPV antigen-specific responses and tumor growth inhibition in multiple pre-clinical models of HPV-positive malignancy.
* In clinical studies done in the Center for Cancer Research (CCR), M7824 as monotherapy has produced a notable objective response rate (35-40%) for metastatic HPV + cancers including Oropharyngeal Squamous Cell Carcinoma (OPSCC) and preclinical studies support the addition of an investigational HPV vaccine with therapeutic intent (PRGN-2009, a gorilla adenoviral based vaccine) to further increase anti-tumor efficacy.

Objectives:

Phase I in participants with recurrent/metastatic HPV positive cancer:

-Primary objective: To determine the safety and recommended phase II dose (RP2D) of PRGN-2009 (HPV vaccine) alone or in combination with M7824 administered at RP2D of 1200 mg every 2 weeks (q2w).

Phase II in participants with newly diagnosed stage I (T1, T2 N1)/II/III p16-positive oropharyngeal cancer and patients with newly diagnosed operable stage II/III/IVA/IVB/HPV + sinonasal squamous cell cancer:

-Primary objective: To determine if HPV vaccine alone (Arm 2A) is able to result in a \>= 2-fold increase in cluster of differentiation 3 (CD3+) tumor infiltrating T cells post treatment compared with pre-treatment in p16-positive oropharyngeal cancer.

Eligibility:

Phase I:

* Men or women of age \>= 18 years old.
* Subjects with cytologically or histologically confirmed locally advanced not amenable to potentially curative local therapies or metastatic HPV associated malignancies:

  * Cervical cancers;
  * p16+ Oropharyngeal cancers;
  * Anal cancers;
  * Vulvar, vaginal, penile, and squamous cell rectal cancers
  * Other locally advanced or metastatic solid tumors (e.g., lung, esophagus) that are known HPV+.
* Prior first line systemic therapy is required

Phase II:

* Men or women of age \>= 18 years old.
* Subjects with newly diagnosed stage I (T1, T2 N1), II or III, II or III p16-positive oropharyngeal squamous cell carcinoma (OPSCC) or stage II/III/IVA/IVB HPV-SNSCC planned for definitive therapy.

Design:

Phase I: Recurrent/metastatic HPV associated cancer:

* A 3+3 dose escalation design will be used which will evaluate PRGN-2009 (HPV vaccine) at two dose levels (1x10\^11 and 5x10\^11 viral particle (VP) units) given as monotherapy followed by a third dose level evaluating the RP2D dose of PRGN-2009 in combination with 1200 mg (RP2D) of M7824. In addition, the combination of PRGN-2009 at RP2D with 1200 mg of M7824 will be expanded to a total of 10 evaluable participants to gauge the preliminary efficacy of the combination of PRGN-2009 and M7824 in participants with advanced disease.
* There will be a 4-week dose limiting toxicity (DLT) evaluation period for each dose level.
* It is expected that up to 22 participants may enroll.

Phase II:

Newly diagnosed p16-positive oropharyngeal cancer:

* Evaluation of HPV vaccine alone (Arm 2A: Stage I (T1,T2 N1)/II/III) as neoadjuvant/ induction therapy before definitive standard of care therapy.
* Participants will receive neoadjuvant/ induction immunotherapy at National Institutes of Health (NIH) Clinical Center and then be referred back to their home institution for definitive standard of care therapy.
* It is expected that up to 20 participants may enroll.
* Newly diagnosed stage II/III/IVA/IVB HPV-SNSCC:
* Enrollment and treatment will occur similarly as participants with p16+oropharyngeal cancer for exploratory correlates to advise possible future trials. Up to 2 participants may enroll in this group.

HPV Vaccine PRGN-2009 Alone or in Combination With Anti-PDL1/TGF-Beta Trap (M7824) in Subjects With HPV Associated Cancers

Phase I/II Trial of HPV Vaccine PRGN-2009 Alone or in Combination With Anti-PD-L1/TGF-Beta Trap (M7824) in Subjects With HPV Positive Cancers

All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request. In addition, all large-scale genomic sequencing data will be shared with subscribers to the database of Genotypes and Phenotypes (dbGaP).

Phase I: In participants with recurrent/metastatic HPV positive cancer - To determine the safety and recommended phase II dose (RP2D) of PRGN-2009 (HPV vaccine) alone or in combination with M7824 administered at RP2D of 1200 mg q2w.

Phase II: In participants with newly diagnosed stage I (T1,T2 N1)/II/III p16-positive oropharyngeal cancer - To determine if HPV vaccine alone (Arm 2A) is able to result in a equal to or greater than 2-fold increase in CD3+ tumor infiltrating T cells post treatment compared with pre-treatment in p16-positive oropharyngeal cancer.

Phase 1: To assess ratio of participants that are hospitalized because of adverse events attributed to disease progression.

Phase II: To determine the 3-year overall and relapse-free survival rate for PRGN-2009 alone (Arm 2A) as neoadjuvant/ induction therapy before definitive standard of care therapy for this population.

Phase 1: To assess overall survival (OS).

Phase 1: To assess progression-free survival time (PFS).

Phase II: To assess the safety of the recommended phase II dose (RP2D) of PRGN-2009 (HPV vaccine) alone in this participant population.

Phase II: To determine if the use of PRGN-2009 alone results in significantly prolonged survival as compared to the expected 80% three-year historical survival for this population.

Phase 1: To assess overall response rate (ORR) according to RECIST 1.1.

National Cancer Institute (NCI)

Principal Investigator

Skin and Connective Tissue Diseases

Breast Neoplasms

Triple Negative Breast Neoplasms

Breast Diseases

Skin Diseases

Regular brain MRI can detect early brain metastases in metastatic Breast cancer with high risk subgroups, such as HER2-positive and triple negative.

Brain MRI will be taken at the time of initial diagnosis, first- and second-line treatment failure. Therefore, the investigators expect that early detection of brain metastases before the onset of symptoms will affect the overall prognosis of MBC patients.

Joohyuk Sohn, MD, Ph.D

Joo Hyuk Sohn, MD, PhD

In general, brain metastases found after development of neurologic symptoms have poor prognosis. Therefore, the investigators aim to investigate whether regular brain MRI (Magnetic Resonance Imaging) can detect early brain metastases and influence survival through early brain management in HER2-positive and triple negative breast cancer.

It is well known that HER2-receptor positive and triple negative metastatic breast cancer (MBC) have poor prognosis than hormone receptor positive metastatic breast cancer. However, as new therapies such as trastuzumab and pertuzumab are introduced, overall survival was extended in patients with metastatic breast cancer compared with the previous 10 years. As a result, the number of breast cancer patients with brain metastases has increased, the demand for treatments of brain metastases is increasing.

The incidence of brain metastases in MBC has been reported to be 7.6% and 10.8% in luminal A / B, respectively. However, HER2-positive and triple negative breast cancer with the incidence of more than 30% of brain metastases were at high risk group of brain metastases.

In general, brain metastases found after development of neurologic symptoms have poor prognosis. Therefore, the investigators aim to investigate whether regular brain MRI (Magnetic Resonance Imaging) can detect early brain metastases and influence survival through early brain management in HER2-positive and triple negative breast cancer.

Brain Monitoring for High Risk of Brain Metastases in Metastatic Breast Cancer

The incidence rates of brain metastases with high risk patients in metastatic breast cancer at initial diagnosis and failure of first- and second-line treatments confirmed by brain MRI

To evaluate the incidence rate of brain oligometastsais (≤ 4) confirmed by brain MRI

To evaluate intracranial progression free survival(PFS) after treatment of brain metastases

To evaluate the overall survival (OS) after diagnosis to brain metastases

To evaluate the period from diagnosis to treatment of brain metastases

To evaluate the cognitive impairment assessment after brain metastases

Yonsei University

Recurrence

Glioma

Glioblastoma

Astrocytoma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Bevacizumab

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

The subjects will undergo 12 months of planned continuous treatment with Optune. The treatment will begin at week 0 and will be continuous throughout the study. Pulsed bevacizumab dosing is defined by at least one cycle on and at least one cycle off. A cycle is defined as 8 weeks in length. If after one cycle on, there is no evidence of a repeat response; bevacizumab will be continued for one more cycle. If after two cycles on, there is no repeat response; bevacizumab will be continued with or without other standard chemotherapy until death. If after at least one cycle on, there is evidence of repeat response, bevacizumab will be discontinued for at least one cycle. In addition, the following will be performed: Bevacizumab will be given, physical examination and quality of life questionnaires will be performed and brain MRI.

Bevacizumab will be given at 10mg/kg IV every 2 weeks.

Optune will be worn continuously for 12 months. Optune is programmed by Novocure to deliver 200 kHz TTFields in two sequential, perpendicular field directions at a maximal intensity of 707mARMS. There will be no adjustments made to the device by investigators or patients/caregivers.

Optune

Brain MRI will be done at screening and every 8 weeks.

The quality of life questionnaires will be performed within 14 days of treatment and every 4 weeks.

Quality of Life Questionnaires

David D Tran, MD, PhD

Glioblastoma multiforme (GBM) is the most common and deadliest primary malignant neoplasm of the central nervous system in adults. Despite an aggressive multimodality treatment approach including surgery, radiation therapy and chemotherapy, overall survival remains poor. Novocure has shown that when properly tuned, very low intensity, intermediate frequency electric fields (TTFields) stunt the growth of tumor cells. The Optune system (NovoTTFTM Therapy) is a portable battery operated device, which produces TTFields within the human body by means of surface transducer arrays. The TTFields are applied to the patient by means of surface transducer arrays that are electrically insulated, so that resistively coupled electric currents are not delivered to the patient. Optune is currently FDA-approved as a single modality treatment for recurrent GBM when both surgical and radiotherapy options have been exhausted as well as combination with adjuvant temozolomide for newly diagnosed GBM.

This research study is being performed to determine whether or not TTFields combined with pulsed bevacizumab treatment increases overall survival in patients with bevacizumab-refractory GBM compared to historical controls treated with continuous bevacizumab alone or in combination with other chemotherapy.

Subjects who have evidence of bevacizumab-refractory GBM will be eligible to participate in this research study. Subjects will undergo 12 months of planned continuous treatment with TTFields followed by pulsed bevacizumab treatment when there is evidence of further progression per RANO, with the option of extending treatment up to a total of 24 months in patients who have not progressed and/or have adequate performance status at the 12 month mark. Pulsed bevacizumab dosing is defined by at least one cycle on and at least one cycle off. A cycle is defined as 8 weeks in length. If after one cycle on, there is no evidence of a repeat response; bevacizumab will be continued for one more cycle. If after two cycles on, there is no repeat response; bevacizumab will be continued with or without other standard chemotherapy until death. If after at least one cycle on, there is evidence of repeat response, bevacizumab will be discontinued for at least one cycle or until progression is noted again per RANO, whichever is later, at which time pulsed bevacizumab will be restarted as outlined above. The investigators believe that this approach will produce peaks and troughs in mitotic activities of glioma cells that render glioma cells more sensitive to the antimitotic activity of Optune during peak growth rates, thus lowering disease burden and increasing survival. In addition, the following will be performed: Bevacizumab will be given at 10mg/kg IV every 2 weeks. Physical examination and quality of life (QoL) assessments will be performed bi-monthly. Brain MRI will be performed every 2 months.

TTFields and Pulsed Bevacizumab for Recurrent Glioblastoma

A Phase 2, Multi-center, Single Arm, Histologically Controlled Study Testing the Combination of TTFields and Pulsed Bevacizumab Treatment in Patients With Bevacizumab-refractory Recurrent Glioblastoma

Overall survival is defined as time interval from date of starting Optune to date of death or censoring whichever happens first.

The Karnofsky Performance Scale is rated from 0 - 100 with 0 = death and 100 = normal without complaints or evidence of disease. A higher score means the patient is better able to carry out daily activities. Patients are evaluable for assessment of QoL after completing at least 8 weeks of treatment with the Optune device with compliance rate \> 60% in at least one 4-week period.

The Mini Mental State Examination (MMSE) it is an 11-question measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall, and language. The maximum score is 30. The higher the score suggests less cognitive impairment. A score of 24-30 suggests no cognitive impairment. A score of 18-23 suggests mild cognitive impairment. A score of 0-17 suggests severe cognitive impairment. Patients are evaluable for assessment of QoL after completing at least 8 weeks of treatment with the Optune device with compliance rate \> 60% in at least one 4-week period.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Brain Metastases Research Platform to Tackle the Challenge of CNS Metastases in Solid Tumours	NCT04109131	CNS Metastases	Samples collect... Samples collect... Samples collect... Brain MRI Samples collect...	18 Years -	Jules Bordet Institute
Evaluation of Anatomy, Clinical and Neuropsychological Long-term Sequelae of Patients Treated With Radiation Therapy for Brain Tumor	NCT02791360	Brain Neoplasms	Brain MRI	18 Years -	Centre Francois Baclesse
HPV Vaccine PRGN-2009 Alone or in Combination With Anti-PDL1/TGF-Beta Trap (M7824) in Subjects With HPV Associated Cancers	NCT04432597	HPV Positive Ca... Vulvar, Vaginal... Anal Cancer Oropharyngeal C... Cervical Cancer	PRGN-2009 (Phas... PRGN-2009 (Phas... M7824 MRI Bone scan CT scan Brain CT Brain MRI Biopsy (Phase I... Biopsy (Phase I...	18 Years -	National Institutes of Health Clinical Center (CC)
Brain Monitoring for High Risk of Brain Metastases in Metastatic Breast Cancer	NCT03617341	Metastatic Brea... Triple Negative...	Brain MRI	19 Years -	Yonsei University
TTFields and Pulsed Bevacizumab for Recurrent Glioblastoma	NCT02663271	Glioblastoma Mu... Glioblastoma Malignant Gliom... GBM	Bevacizumab Optune Brain MRI Quality of Life...	22 Years -	University of Florida

Spots Global Cancer Trial Database for brain mri

Every month we try and update this database with for brain mri 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 brain mri

Every month we try and update this database with for brain mri 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 brain mri 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.