Neoplasms

Symptoms and General Pathology

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Nervous System Diseases

Neoplasm Metastasis

Brain Neoplasms

Neoplastic Processes

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Antineoplastic Agents

All Drugs and Chemicals

Taxane

Dose Escalation followed by Dose Expansion.

Dose Escalation Phase: The maximum tolerated dose (MTD) for TPI 287 given concurrently with Fractionated Stereotactic Radiotherapy (FSRT) will be determined using the standard 3+3 study design.

Dose Expansion Phase: Participants will be treated with TPI 287 at MTD given concurrently with FSRT to further assess toxicity and tumor response.

TPI 287 is an infusion given through veins. Dose escalation will begin at 14 mg/m\^2/dose. Dose expansion will begin at the maximum tolerated dose (MTD).

TPI 287

The prescription dose will be 25 gray (Gy) in 5 daily fractions delivered to the planning target volume (PTV).

Fractionated Stereotactic Radiotherapy (FSRT)

Solmaz Sahebjam, M.D.

The main purpose of this study is to see whether addition of TPI 287 to FSRT is safe and tolerable. Researchers also want to find out if adding TPI 287 to FSRT can help with better controlling the growth of brain lesions in people with brain metastases from their cancer.

Standard of care for treatment of patients with brain metastases, which are considered not surgically removable, is radiation therapy to the brain lesions. This treatment is called Fractionated Stereotactic Radiotherapy (FSRT) and is given without chemotherapy and usually over 5 days.

Researchers of this study want to find out if adding an investigational drug, called TPI 287, to standard radiation therapy (FSRT) can help people with brain metastases from cancer. TPI 287 is a drug that is being tested and is not approved for sale in the United States by the U.S. Food and Drug Administration (FDA).

Fractionated Stereotactic Radiotherapy (FSRT) in Treatment of Brain Metastases

A Phase 1 Study of TPI 287 Concurrent With Fractionated Stereotactic Radiotherapy (FSRT) in Treatment of Brain Metastases From Advanced Breast and Non-Small Cell Lung (NSCL) Cancer

MTD of TPI 287 given concurrently with Fractionated Stereotactic Radiotherapy (FSRT) to treat brain metastases from advanced solid tumors.

The percentage of participants with advanced or metastatic cancer who have achieved complete response, partial response and stable disease to a therapeutic intervention in clinical trials of anticancer agents. Complete Response (CR): The tumor is no longer seen on two sequential MRI scans, and the patient is on no steroids or only adrenal-maintenance dose of steroids. Partial Response (PR): ≥ 50% decrease in the product of two diameters of target lesions on two sequential MRIs, taking as reference the baseline product of two diameters, provided that the patient has not had his/her dose of steroids increased since the last evaluation period. Stable Disease (SD): The scan shows no change, taking as reference the smallest product of diameters while on study. Patient should be receiving stable or decreasing doses of steroids.

PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Response Evaluation Criteria in Solid Tumors (RECIST v.1.0) definition of Progression follows. One or more of the following must occur: 20% or greater increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). Appearance of any new lesion/site. Death due to disease without prior documentation of progression and without symptomatic deterioration.

Cortice Biosciences, Inc.

H. Lee Moffitt Cancer Center and Research Institute

Gland and Hormone Related Diseases

Musculoskeletal Diseases

Rare Diseases

Pituitary Diseases

Glioma

Meningioma

Pituitary Neoplasms

Skull Base Neoplasms

Dermatologic Agents

Aminolevulinic Acid

Photosensitizing Agents

5-aminolevulinic acid

David W Roberts, MD

Keith Paulsen, PhD

Removing a tumor from your brain is hard to do because, very often, brain tumors do not have boundaries that are easy for your surgeon to find. In many cases, the surgeon can't tell exactly where the tumor begins or ends. The surgeon usually can remove most of your tumor by looking at the MRI images that were taken of your brain before surgery. However, the surgeon does not have any good way to tell if the entire tumor has been removed or not. Removing the entire tumor is very important because leaving tumor behind may allow it to grow back which could decrease your chances of survival.

It is possible to detect tumor cells by making them glow with a specific color of light (a process called fluorescence). This can be done by having you take the drug, ALA, before your surgery. ALA is a molecule that already exists in the cells of your body. Once enough of it is in your body, it gets converted into another molecule named PpIX. If blue light is shined on a tumor that has enough PpIX, it will glow with red light (fluorescence) that can be detected with a special camera. In this study, we want to determine how the fluorescence (red light) is related to the tumor which appears in the images that are normally taken of your brain (which the surgeon uses to guide the removal of your tumor) and the tumor tissue that will be removed during your surgery. Removing the entire tumor is very important because leaving tumor behind may allow it to grow back which could decrease your chances of survival.

The first phase of study (Stage I) will use FI coregistered with pMR, iUS and iSV images to test the overall hypothesis that there is a high degree of spatial correlation between local tissue FI signal and coregistered conventional imaging and corresponding histopathology. Additionally, coregistered probe measurements and biopsy specimens will be acquired intraoperatively. Biopsy specimens will be processed post-operatively (via fluorescence microscopy and chemical spectrofluorimetry) to assess PpIX concentration which will allow direct comparisons of FI signal strength with PpIX production (based on both in vivo probe data and ex vivo histological quantification) as a function of histological grade. The study protocol is outlined below. Because of the overall interest and importance of relating this data to the existing body of literature and the excellent safety record of oral administration of ALA reported in these trials \[1, 33-36\], we will use the same dose/time schedule described in \[1, 33\]. The operative procedures will follow existing practice at Dartmouth for image-guided resection of meningiomas, pituitary adenomas and metastases with additional acquisition of FI and biopsy data at predefined time points that are related to the expected volume of tumor tissue. In this first phase of the study, resection decisions will not be made based on FI data alone. Should residual fluorescence remain after the intended resection volume has been removed further excisions will require biopsy confirmation in the OR. It is anticipated that 234 patients will be enrolled in Stage I.

Fluorescence Guided Resection of Brain Tumors

Co-registered Fluorescence-Enhanced Resection of Brain Tumors Stage I: Correlation With MR and Biopsy

National Institute of Neurological Disorders and Stroke (NINDS)

David W. Roberts

Professor of Surgery (Neurosurgery)

David W. Roberts, MD

Removing a tumor from a patients brain is hard to do because, very often, brain tumors do not have boundaries that are easy for the patients surgeon to find. In many cases, the surgeon can't tell exactly where the tumor begins or ends. The surgeon usually can remove most of the patient's tumor by looking at the MRI images that were taken of the patient's brain before surgery. However, the surgeon does not have any good way to tell if the entire tumor has been removed or not. Removing the entire tumor is very important because leaving tumor behind may allow it to grow back which could decrease the chances of survival.

ALA-induced PpIX Fluorescence During Brain Tumor Resection

Quantification of ALA-induced PpIX Fluorescence During Brain Tumor Resection

To estimate the probability of tumor distribution for a given PpIX concentration by comparing intraoperative measurements with coregistered histopathology obtained from biopsy sampling during the procedure

MRI-Guided Focused Ultrasound Feasibility Study for Brain

ExAblate transcranial system

The purpose of this study is to evaluate the safety of MRI-guided focused ultrasound thermal ablation of brain tumors performed through intact human skull using the ExAblate transcranial system. We will collect data to establish the basic safety of this type of treatment as the basis for later studies that will evaluate its clinical efficacy.

In this non-randomized feasibility study, FUS under MRI-guidance and thermometry will be given through intact human skull to brain tumor in up to ten (10) subjects. These subjects will be followed over a 3-month period with contrast MRI and clinical exams.

The objectives are:

1. To evaluate the safety of ExAblate TcMRgFUS treatment delivered through intact human skull to the brain, during the treatment, and during the follow-up period of 3 months.
2. To evaluate the effect of thermal ablation in the target tumor with contrast MR imaging to identify viable tumor, and non-viable thermally ablated tissue.

MRI-Guided Focused Ultrasound Feasibility Study for Brain Tumors

A Study to Evaluate the Safety and Feasibility of Transcranial MRI-Guided Focused Ultrasound Surgery in the Treatment of Brain Tumors

To evaluate the safety of ExAblate TcMRgFUS treatment delivered through intact human skull to the brain, during the treatment and during the follow-up period of 3 months.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Fractionated Stereotactic Radiotherapy (FSRT) in Treatment of Brain Metastases	NCT02187822	Brain Metastase... Generalized Mal... Brain Lesions	TPI 287 Fractionated St...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Fluorescence Guided Resection of Brain Tumors	NCT00870779	Brain Tumors	5-aminolevulini...	21 Years -	Dartmouth-Hitchcock Medical Center
Fractionated Stereotactic Radiotherapy (FSRT) in Treatment of Brain Metastases	NCT02187822	Brain Metastase... Generalized Mal... Brain Lesions	TPI 287 Fractionated St...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
ALA-induced PpIX Fluorescence During Brain Tumor Resection	NCT02191488	Brain Tumors	5-aminolevulini...	21 Years -	Dartmouth-Hitchcock Medical Center
Fluorescence Guided Resection of Brain Tumors	NCT00870779	Brain Tumors	5-aminolevulini...	21 Years -	Dartmouth-Hitchcock Medical Center
MRI-Guided Focused Ultrasound Feasibility Study for Brain Tumors	NCT00147056	Brain Tumor	ExAblate transc...	18 Years - 70 Years	InSightec

Spots Global Cancer Trial Database for brain lesions