Neoplasms

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Nervous System Diseases

Rare Diseases

Glioblastoma

Body Weight

Glioma

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

peritumoral glial cell infiltration

Betty JEAN

This study will examine the use of a variation of standard magnetic resonance imaging (MRI) called diffusion tensor MRI (DT-MRI), in order to evaluate the peripheral white matter infiltration of high grade brain tumors. Organized architecture is destroyed once brain tumor cells are infiltrating surrounding tissue. The infiltrated tissue is then isotropic (or less anisotropic). DT-MRI can assess anisotropy after datasets post treatment. Primary outcome is to find if a correlation exists between GA (generalized anisotropy) and the infiltration percentage of stereotactic peritumoral biopsies.

Patients with high grade brain tumor undergo a usual brain tumor MRI protocol as well as a 20 or 60 directions DT-MRI sequence upon patient collaboration. Images are acquired using a 3 Tesla MRI scanner (GE MR750 Discovery).

The usual brain tumor MRI protocol contains the following sequences: 3DT1, Axial T2, Flair, T2 EG, diffusion (b0-b1000), 3DT1CE.

They will then undergo stereotactic tumor biopsies with Leksell frame mounted.

Biopsy targets will be surgically planned. The coordinates of this first biopsy will be recorded for later coregistration with DT-MRI datasets.

Histopathologic analysis of the biopsies will be done using usual procedure. various immunologic markers such as MAP2, Ki67 will be used on the first biopsy sample in order to estimate the percentage of infiltration (ratio of tumor cells number over total cells number).

Analysis of DT-MRI datasets will be done using home-made software for high order tensor resolution and GA estimation at the exact coordinates of the biopsy sites.

Finally a statistical analysis (Pearson or Spearman) will be done to correlate GA and the infiltration percentage.

Histopathologic Evaluation of High Grade Brain Tumors by High Order Diffusion Tensor Imaging

Histopathologic Evaluation of High Grade Brain Tumors by High Order Diffusion Tensor Imaging: Peritumoral Glial Cell Infiltration Quantitative Method

University Hospital, Clermont-Ferrand

Recurrence

Disease Attributes

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

The investigators will inject the activated NK cells, 1-3 times with weekly interval into tumor cavity.

Activated NK cell injection in tumor cavity of patient with GBM (Glioblastoma Multiform)

NK cell therapy

Marzieh Ebrahimi, PhD

Zohreh Habibi, M.D

Niloufar Shayan Asl, MSc

Monire Mohammad, MSc

Amirali Hamidieh, MD,PhD

Abolhossein Shahverdi, PhD

Glioblastoma multiform is one of the most invasive and deadly cancers that progresses rapidly and leads to death. Surgery with radiotherapy /chemotherapy, as a treatment approach is ineffective in some cases and is associated with relapse and death. Immunotherapy is a special strategy that used as an adjunct therapy in various cancers and among the various methods of immunotherapy; it seems that cell therapy with NK cells is of special importance. A previous study conducted at the Royan Research Institute showed that NK cell proliferation and amplification resulted in the removal of glioblastoma tumor masses in the animal model. The animals had no evidence of tumor recurrence after treatment, and all tumor-related complications resolved after treatment. Therefore, in this study, the investigators intend to evaluate the safety of ex vivo activated cells in 5 patients with glioblastoma multiform whose disease has returned after treatment and who have not had any appropriate treatment.

1- patient selection 2- leukapheresis 3- CD56+ cells isolation 4- NK cells activation 5- assessment of functionality and purity 6- quality control tests 7-NK cell injection in tumor cavity.

The investigators will enroll 5 patients (3-60 year, both sex, -Lansky performance scale/Karnofsky performance scale: 70-100%) with recurrent Glioblastoma Multiform. A haploidentical donor will enter for each patient.

Nk Cell Therapy for Recurrent Glioblastoma Multiform Patients

The Safety Evaluation of Ex Vivo Activated Haploidentical Natural Killer Cells (NK) in Recurrent Glioblastoma Multiform Patients (Clinical Trial Phase I)

Toxicity as assessed by NCI CTCAE version 3.0

Defined as the number and severity of adverse events

Safety evaluated by assessing the medical symptoms measurement: Fever, Hysteria and Convulsion

Safety evaluated by assessing the medical symptoms measurement: Meningitis, Neurological disorders

Safety evaluated by assessing the medical symptoms measurement: Loss of consciousness

Defined tumoral residua and tumor cell recurrence

Evaluation of patient's life extension followed by NK cell therapy

Tehran University of Medical Sciences

Royan Institute

Arm

Phase I:

Experimental: Dose Escalation for Cohorts 1-8 Each participant will receive a single administration of 186RNL. At each dose level, a minimum of three to a maximum of six participants will be enrolled.

If no dose limiting toxicity is observed in the initial three participants, then the next higher dose level cohort will open for enrollment.

The dose escalation scheme will follow a modified Fibonacci dose escalation scheme as shown below:

COHORT ACTIVITY Cohort 1 (1.0 mCi) Cohort 2 (2.0 mCi) Cohort 3 (4.0 mCi) Cohort 4 (8.0 mCi) Cohort 5 (13.4 mCi) Cohort 6 (22.3 mCi) Cohort 7 (31.2 mCi) Cohort 8 (41.5 mCi)

Phase 2:

Single arm, prospective study utilizing a non-DLT dose obtained from the dose escalation portion of IND 116117, NIH-NCI Grant (22.3 mCi (total 186RNL activity) at a concentration of 2.5 mCi/mL and 8.8 mL total volume).

At the time of stereotactic biopsy a catheter will be placed within the tumor using stereotactic guidance. Once the patient has adequately recovered from the procedure as determined by the neurosurgeon, 186RNL will be infused through the CED catheter at the predetermined dose. Spectroscopic imaging will then be obtained at predefined time points to visualize the distribution of the 186RNL as well as calculated the actual dose retained within the tumor. Patients will be monitored longitudinally for evidence of toxicity and response by MRI.

Rhenium Liposome Treatment

Melissa Moore, PhD

Norman LaFrance, MD (CMO)

Omar Raslan

Toral Patel, MD

Sharon Ji

Jeffrey Weinberg, MD

Epp Goodwin

Andrew J Brenner, M.D., Ph.D.

John R Floyd, M.D.

William T Phillips, M.D.

Andrew J Brenner, PhD

This is a multi-center, sequential cohort, open-label, volume and dose escalation study of the safety, tolerability, and distribution of 186RNL given by convection enhanced delivery to patients with recurrent or progressive malignant glioma after standard surgical, radiation, and/or chemotherapy treatment. The study uses a modified Fibonacci dose escalation, followed by an expansion at the maximum tolerated dose (MTD) to determine efficacy. The starting absorbed dose is 1mCi in a volume of 0.660mL.

The Phase I portion of the clinical study evaluates a single dose of 186RNL (radionuclide clinical study drug) administered through a convection enhanced delivery catheter (CED catheter) in participants with recurrent Glioma (GBM). The clinical study treatment consists of a single administered dose of 186RNL per participant. The clinical study will include the evaluation of multiple separate dose levels (dose escalation). Three to six participants may be treated at each dose. The maximum number of participants to be enrolled in the study is approximately 21. The clinical study treatment will be administered, following CED placement, by the clinical study physician. Participants will be followed for up to 36 months after the clinical study drug is administered.

The Phase II portion of the clinical study is a multicenter, single arm, prospective study utilizing a non-DLT dose obtained from the dose escalation portion of IND 116117, NIH-NCI Grant (22.3 mCi (total 186RNL activity) at a concentration of 2.5 mCi/mL and 8.8 mL total volume). The maximum number of participants to be enrolled in the Phase II study is approximately 34. The clinical study treatment will be administered, following CED placement, by the clinical study physician. Participants will be followed for up to 36 months after the clinical study drug is administered.

The U.S. Food and Drug Administration (FDA) has not approved 186RNL for this specific disease.

Phase 1:

• Single arm, prospective study utilizing a modified Fibonacci dose escalation scheme.

Phase 2:

• Single arm, prospective study utilizing a non-DLT dose obtained from the dose escalation portion of IND 116117, NIH-NCI Grant (22.3 mCi (total 186RNL activity) at a concentration of 2.5 mCi/mL and 8.8 mL total volume).

Maximum Tolerated Dose, Safety, and Efficacy of Rhenium Nanoliposomes in Recurrent Glioma (ReSPECT)

A Dual Phase 1/2, Investigator Initiated Study to Determine the Maximum Tolerated Dose, Safety, and Efficacy of 186Rhenium Nanoliposomes (186RNL) in Recurrent Glioma (CTRC# 12-02)

Evaluation of any toxicity associated with research treatment per Common Toxicity Criteria for Adverse Events.

To assess overall survival (OS) following 186RNL administration by convection enhanced delivery (CED) in patients with recurrent glioma.

SPECT imaging of the radioactive materials spread across the tumor and surrounding brain

Evaluation of overall response rate by RANO criteria

Disease specific progression free survival

Evaluation of any toxicity associated with research treatment as determined by the most recent version of the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).

To assess the safety and tolerability of 186RNL by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 criteria. Safety and tolerability will be defined by the percent of participants experiencing ≥ Grade 3 AE/SAE.

To determine the objective response rate (ORR) from the date of complete or partial response or Serious Treatment-Emergent Adverse Events (Safety and Tolerability)

To determine progression free survival at 6 months (PFS-6) as measured from the initiation of study treatment until the date of first documented progression by modified RANO criteria (recognizing the potential of pseudo progression significantly complicating the use of the RANO criteria) or date of death from any cause.

To determine progression free survival (PFS) as measured from the initiation of study treatment until the date of first documented progression by modified RANO criteria (recognizing the potential of pseudo progression significantly complicating the use of the RANO criteria) where progression is defined as \>25% in the sum of products of the perpendicular diameters of CE lesions, evidence of new lesion(s), or date of death from any cause, whichever comes first.

Evaluate assessing quality of life using a Quality-of-Life Questionnaire (developed in collaboration with FDA, Investigators and established glioblastoma patient advocacy groups)

National Cancer Institute (NCI)

Plus Therapeutics

Gliosarcoma

Anaplastic Astrocytoma

Antineoplastic Agents

All Drugs and Chemicals

Channel Blockers

Anticonvulsants

Analgesics

Central Nervous System Depressants

Psychotropic Drugs

Central Nervous System Stimulants

Temozolomide

Topotecan

Phenytoin

Carbamazepine

Phenobarbital

Oxcarbazepine

Convulsants

Antineoplastic Agents, Alkylating

Alkylating Agents

Topoisomerase I Inhibitors

Enzyme Inhibitors

Two separate strata to accrue independently. Stratum 1: Patients taking receiving Dilantin, Tegretol, Trileptal or Phenobarbital. Stratum 2: Patients on anti-convulsants other than Dilantin, Tegretol, Trileptal or Phenobarbital or patients not on any anti-convulsants

Temozolomide is taken by mouth once day, every day for 5 consecutive days at dose of 200 mg/m2/day.

Oral Topotecan will be taken daily for 5 consecutive days beginning 12-24 hrs after 1st dose of Temozolomide. Dose escalation of Oral Topotecan will be carried out in cohorts of 3 new subjects beginning w dose level 1 @ 0.75 mg/m2/dose.

Oral Topotecan and Temodar

Katherine B Peters, MD, PhD

Objectives:

* To determine the maximum tolerated dose of oral topotecan when administered with Temodar to patients with malignant glioma
* To characterize any toxicity associated with the combination oral topotecan and Temodar.
* To observe patients for clinical antitumor response when treated with oral topotecan and Temodar.

Subjects are patients with glioblastoma (GBM), anaplastic astrocytoma (AA) or grade 3 or greater WHO astrocytic, oligodendroglial or mixed glial tumors, which were initially diagnosed by histologic examination of biopsy/resection. Modified classical "3+3" phase I design used to determine maximum tolerated dose of topotecan in combination with Temodar.

Ph I Oral Topotecan and Temozolomide for Patients With Malignant Gliomas

Phase I Trial of Oral Topotecan Plus Temodar in the Treatment of Patients With Malignant Gliomas

GlaxoSmithKline

Schering-Plough

Katy Peters

Assistant Professor

Each participant will receive a single administration of 186RNL. The proposed dose is up to 8.8 mL as a single administration with an administered dose of 22.3 mCi.

Retreatment Rhenium Liposome

Marc Hedrick, MD

This is an open-label, multicenter, Phase 1 study to establish the safety and efficacy/tolerability of a single dose of 186RNL by the intraventricular route (via intraventricular catheter) for recurrence glioma in patients who received a prior treatment of 186RNL.

This Phase I clinical study evaluates a single dose of 186RNL (radionuclide clinical study drug) administered through a convection enhanced delivery catheter (CED catheter) in participants who have already received a prior treatment of 186RNL.

The clinical study treatment consists of a single administered dose of 186RNL per participant. The proposed dose is up to 8.8 mL as a single administration with an administered dose of 22.3 mCi.

An estimated number of participants to be enrolled in the study is approximately 40.

The clinical study treatment will be administered, following CED placement, by the clinical study physician.

Post-treatment evaluations will be done at Days 3, 7, 14, 28, and every subsequent 28-day interval thereafter until disease progression is confirmed and all treatment related toxicities are resolved. The minimum assessment period for toxicities is 12 weeks.

The U.S. Food and Drug Administration (FDA) has not approved 186RNL for this specific disease.

Safety & Efficacy/Tolerability of Rhenium-186 NanoLiposomes (186RNL) for Patients Who Received a Prior 186RNL Treatment

A Single Arm Open Label Study to Determine the Safety and Efficacy/Tolerability of Rhenium-186 NanoLiposomes (186RNL) for Recurrence of Glioma in Patients Who Received a Prior Treatment With 186RNL

Safety and tolerability assessed by number of participants with treatment-related toxicities and/or adverse events as assessed by CTCAE v4.0 with 4-week evaluation periods for toxicity and disease assessment until disease progression is suspected.

To assess overall survival following 186RNL in patients with bevacizumab naïve recurrent glioblastoma following treatment with a second administration of 186RNL.

To assess the dose distribution of a second dose of 186RNL by CED.

To determine the overall response rate by Radiographic Assessment in Neuro-Oncology (RANO) criteria following 186RNL treatment.

To determine disease specific progression-free survival after 186RNL treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Histopathologic Evaluation of High Grade Brain Tumors by High Order Diffusion Tensor Imaging	NCT01699269	High Grade Brai...	peritumoral gli...	18 Years - 85 Years	University Hospital, Clermont-Ferrand
Nk Cell Therapy for Recurrent Glioblastoma Multiform Patients	NCT05108012	Glioblastoma Mu... Recurrent Gliob...	NK cell therapy	3 Years - 60 Years	Royan Institute
Maximum Tolerated Dose, Safety, and Efficacy of Rhenium Nanoliposomes in Recurrent Glioma (ReSPECT)	NCT01906385	Glioma	Rhenium Liposom...	18 Years -	Plus Therapeutics
Ph I Oral Topotecan and Temozolomide for Patients With Malignant Gliomas	NCT00610571	Glioblastoma Gliosarcoma Anaplastic Astr...	Oral Topotecan ...	18 Years -	Duke University
Safety & Efficacy/Tolerability of Rhenium-186 NanoLiposomes (186RNL) for Patients Who Received a Prior 186RNL Treatment	NCT05460507	Glioma	Retreatment Rhe...	18 Years -	Plus Therapeutics
Histopathologic Evaluation of High Grade Brain Tumors by High Order Diffusion Tensor Imaging	NCT01699269	High Grade Brai...	peritumoral gli...	18 Years - 85 Years	University Hospital, Clermont-Ferrand
Ph I Oral Topotecan and Temozolomide for Patients With Malignant Gliomas	NCT00610571	Glioblastoma Gliosarcoma Anaplastic Astr...	Oral Topotecan ...	18 Years -	Duke University
Histopathologic Evaluation of High Grade Brain Tumors by High Order Diffusion Tensor Imaging	NCT01699269	High Grade Brai...	peritumoral gli...	18 Years - 85 Years	University Hospital, Clermont-Ferrand

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