Treatment Trials

33 Clinical Trials for Various Conditions

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RECRUITING
NEO100 and High-Grade Meningioma
Description

This multi-site, Phase 2 clinical trial is an open-label study to identify the safety, pharmacokinetics, and efficacy of a repeated dose regimen of NEO100 (perillyl alcohol) for the treatment of patients with residual high-grade meningioma following resection surgery, radiographically-confirmed progression of high-grade meningioma or recurrent high-grade meningioma. There will be up to 30 patients enrolled in this study to have 29 evaluable patients. NEO100 will be self-administered four times daily on a 28-day treatment cycle until disease progression, death or patient withdraw from study for any reason, whichever occurs first.

ACTIVE_NOT_RECRUITING
Phase II Trial of Pembrolizumab in Recurrent or Residual High Grade Meningioma
Description

This research study is studying a drug as a possible treatment for High Grade Meningioma. The drug involved in this study is an immunotherapy drug called pembrolizumab

RECRUITING
A Trial of Increased Dose Intensity Modulated Proton Therapy (IMPT) for High-Grade Meningiomas
Description

This research study is studying radiation therapy as a possible treatment for meningioma or tumor on the lining of the brain. The study drug or intervention involved in this research study is Intensity Modulated Proton Therapy (IMPT)

SUSPENDED
Rare CNS Tumors Outcomes &Risk
Description

Background: Primary tumors of the brain and spine are those that start in the brain or spine. These tumors are rare, accounting for \<2% of all cancers diagnosed in the United States. Some of these tumors occur in less than 2,000 people per year. Researchers want to study a large group of people with this kind of tumor. They want to learn more about the tumors, including the risk factors related to how they develop in adults. Objective: To collect health and gene data to learn about what changes are associated with a rare CNS Tumors, to eventually screen for these changes or target the genes in treatment. Eligibility: Adult participants \>= 18 years of age who self- identify as being diagnosed with one of 12 rare CNS tumors, including: Atypical teratoid rhabdoid tumor (ATRT); Brainstem and midline gliomas; Choroid plexus tumors; Ependymoma; High grade meningioma; Gliomatosis cerebri; Medulloblastoma; Oligodendroglioma / Anaplastic oligodendroglioma; Pineal region tumors; Pleomorphic xanthroastrocytoma / Anaplastic pleomorphic xanthroastrocytoma; PNET (Supratentorial embryonal tumor); Primary CNS sarcoma / Secondary CNS sarcoma (Gliosarcoma). Design: Participants will be invited to participate through an ad on the CERN Foundation website (ependymoma), information on the Neuro-Oncology Branch website and other identified advocacy and social media sites and direct mailer to those who have already participated in the EO projects. (Registered Trademark) * Interested participants will complete an enrollment form that will be sent to the study coordinator. * The coordinator will then send the participant a consent form and schedule a time for phone consent. * Participants will complete the Rare CNS tumors Outcomes Survey and once completed, the Rare CNS tumors Risk survey. (Registered Trademark) * The questions on the Outcomes Survey will include treatment history, symptoms social and clinical information and it should take about 25-35 minutes. The Risk survey will cover their demographic information, personal medical history, family medical history and environmental exposures. This should take about 52 minutes. * Participants who have physical problems can have help with the surveys and forms. * Once the surveys are completed, participants will be mailed a kit to collect saliva for germline DNA. Participants will ship the sample to the study team in a prepaid envelope * If the sample is not sufficient, participants will be contacted to give provide an additional sample....

TERMINATED
Panobinostat and Stereotactic Radiation Therapy in Treating Patients With Brain Tumors
Description

This is an open label phase I clinical trial with two arms, representing single and fractionated radiation therapy (Figure 4.1). Within each arm the radiation dose is pre-determined and not escalated. Panobinostat will be administered orally 3 times a week for 2 weeks. Panobinostat will be dose-escalated independently in each arm. There is no intra-patient dose escalation. Recurrent gliomas (Arm A) will be treated according to the Jefferson protocol for re-irradiation, 10 fractions each of 3.5Gy delivered over 2 weeks. Panobinostat will be administered orally three times a week for 2 weeks, starting on day 1 or 2 of radiation therapy. High-grade meningiomas (Arm A) will be treated with 6 weeks/30 fractions of fractionated radiation therapy, to a total dose of between 54 Gy and 60 Gy in fractions of either 1.8Gy or 2Gy. Panobinostat will be administered orally three times a week for 2 weeks, starting on the day of 1st fraction of radiation. Large brain metastases (Arm B) will be treated with a single fraction of radiosurgery. Panobinostat will be administered orally three times a week for 2 weeks, starting on the day of radiation. The radiosurgery may be delivered by either LINAC, gamma-knife, cyber-knife or tomotherapy technology.

RECRUITING
Lutathera for Treatment of Recurrent or Progressive High-Grade CNS Tumors
Description

This study will evaluate the safety and efficacy of Lutathera (177Lu-DOTATATE) in patients with progressive or recurrent High-Grade Central Nervous System (CNS) tumors and meningiomas that demonstrate uptake on DOTATATE PET. The drug will be given intravenously once every 8 weeks for a total of up to 4 doses over 8 months in patients aged 4 to \<12 years (Phase I) or 12 to \</=39 years (Phase II) to test its safety and efficacy, respectively. Funding Source - FDA OOPD (grant number FD-R-0532-01)

TERMINATED
Photodynamic Therapy (PDT) For Recurrent High Grade Gliomas
Description

This study will be aimed at investigating the effectiveness of a treatment for brain tumors called Photodynamic Therapy, or PDT. Briefly, a subject will receive a light-sensitive drug, called Photofrin®, the day before a tumor removal surgery. The next day, after the tumor is removed, red light from a laser will be shone into the tumor cavity through a light-diffusing sphere. This light will activate the photosensitizer, and possibly kill any tumor cells that may be left. We plan to measure how long the subject may go without a new tumor regrowth, and overall how long subjects survive. We will compare these results to typical results to see if we are seeing any improvements. Objective: To define the antitumor activity of Photofrin® and laser light activation within the confines of a Phase II study.

COMPLETED
SJDAWN: St. Jude Children's Research Hospital Phase 1 Study Evaluating Molecularly-Driven Doublet Therapies for Children and Young Adults With Recurrent Brain Tumors
Description

Approximately 90% of children with malignant brain tumors that have recurred or relapsed after receiving conventional therapy will die of disease. Despite this terrible and frustrating outcome, continued treatment of this population remains fundamental to improving cure rates. Studying this relapsed population will help unearth clues to why conventional therapy fails and how cancers continue to resist modern advances. Moreover, improvements in the treatment of this relapsed population will lead to improvements in upfront therapy and reduce the chance of relapse for all. Novel therapy and, more importantly, novel approaches are sorely needed. This trial proposes a new approach that evaluates rational combination therapies of novel agents based on tumor type and molecular characteristics of these diseases. The investigators hypothesize that the use of two predictably active drugs (a doublet) will increase the chance of clinical efficacy. The purpose of this trial is to perform a limited dose escalation study of multiple doublets to evaluate the safety and tolerability of these combinations followed by a small expansion cohort to detect preliminary efficacy. In addition, a more extensive and robust molecular analysis of all the participant samples will be performed as part of the trial such that we can refine the molecular classification and better inform on potential response to therapy. In this manner the tolerability of combinations can be evaluated on a small but relevant population and the chance of detecting antitumor activity is potentially increased. Furthermore, the goal of the complementary molecular characterization will be to eventually match the therapy with better predictive biomarkers. PRIMARY OBJECTIVES: * To determine the safety and tolerability and estimate the maximum tolerated dose/recommended phase 2 dose (MTD/RP2D) of combination treatment by stratum. * To characterize the pharmacokinetics of combination treatment by stratum. SECONDARY OBJECTIVE: * To estimate the rate and duration of objective response and progression free survival (PFS) by stratum.

Conditions
Anaplastic AstrocytomaAnaplastic EpendymomaAnaplastic GangliogliomaAnaplastic MeningiomaAnaplastic OligodendrogliomaPleomorphic Xanthoastrocytoma, AnaplasticAtypical Teratoid/Rhabdoid TumorBrain CancerBrain TumorCentral Nervous System NeoplasmsChoroid Plexus CarcinomaCNS Embryonal Tumor With Rhabdoid FeaturesGanglioneuroblastoma of Central Nervous SystemCNS TumorEmbryonal Tumor of CNSEpendymomaGlioblastomaGliomaGlioma, MalignantMedulloblastomaMedulloblastoma; Unspecified SiteMedulloepitheliomaNeuroepithelial TumorNeoplasmsNeoplasms, NeuroepithelialPapillary Tumor of the Pineal Region (High-grade Only)Pediatric Brain TumorPineal Parenchymal Tumor of Intermediate Differentiation (High-grade Only)PineoblastomaPrimitive Neuroectodermal TumorRecurrent MedulloblastomaRefractory Brain TumorNeuroblastoma. CNSGlioblastoma, IDH-mutantGlioblastoma, IDH-wildtypeMedulloblastoma, Group 3Medulloblastoma, Group 4Glioma, High GradeNeuroepithelial Tumor, High GradeMedulloblastoma, SHH-activated and TP53 MutantMedulloblastoma, SHH-activated and TP53 WildtypeMedulloblastoma, Chromosome 9q LossMedulloblastoma, Non-WNT Non-SHH, NOSMedulloblastoma, Non-WNT/Non-SHHMedulloblastoma, PTCH1 MutationMedulloblastoma, WNT-activatedEpendymoma, RecurrentGlioma, Recurrent High GradeGlioma, Recurrent MalignantEmbryonal Tumor, NOSGlioma, Diffuse Midline, H3K27M-mutantEmbryonal Tumor With Multilayered Rosettes (ETMR)Ependymoma, NOS, WHO Grade IIIEpendymoma, NOS, WHO Grade IIMedulloblastoma, G3/G4Ependymoma, RELA Fusion Positive
TERMINATED
Palbociclib Isethionate in Treating Younger Patients With Recurrent, Progressive, or Refractory Central Nervous System Tumors
Description

This phase I trial studies the side effects and best dose of palbociclib isethionate in treating younger patients with central nervous system tumors that have grown, come back, or not responded to treatment. Palbociclib isethionate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

WITHDRAWN
Efficacy of 68Ga-DOTATOC Positron Emission Tomography (PET) CT in Children and Young Adults With Brain Tumors
Description

This pilot clinical trial studies gallium Ga 68-edotreotide (68Ga-DOTATOC) positron emission tomography (PET)/computed tomography (CT) in finding brain tumors in younger patients. Diagnostic procedures, such as gallium Ga 68-edotreotide PET/CT imaging, may help find and diagnose brain tumors.

Conditions
Acoustic SchwannomaAdult Anaplastic AstrocytomaAdult Anaplastic EpendymomaAdult Anaplastic MeningiomaAdult Anaplastic OligodendrogliomaAdult Brain Stem GliomaAdult Choroid Plexus TumorAdult CraniopharyngiomaAdult Diffuse AstrocytomaAdult EpendymoblastomaAdult EpendymomaAdult Giant Cell GlioblastomaAdult GlioblastomaAdult GliosarcomaAdult Grade I MeningiomaAdult Grade II MeningiomaAdult MedulloblastomaAdult Meningeal HemangiopericytomaAdult Mixed GliomaAdult Myxopapillary EpendymomaAdult OligodendrogliomaAdult Papillary MeningiomaAdult Pilocytic AstrocytomaAdult Pineal Gland AstrocytomaAdult PineoblastomaAdult PineocytomaAdult Subependymal Giant Cell AstrocytomaAdult SubependymomaAdult Supratentorial Primitive Neuroectodermal Tumor (PNET)Childhood Choroid Plexus TumorChildhood CraniopharyngiomaChildhood EpendymoblastomaChildhood Grade I MeningiomaChildhood Grade II MeningiomaChildhood Grade III MeningiomaChildhood High-grade Cerebellar AstrocytomaChildhood High-grade Cerebral AstrocytomaChildhood Infratentorial EpendymomaChildhood Low-grade Cerebellar AstrocytomaChildhood Low-grade Cerebral AstrocytomaChildhood MedulloepitheliomaChildhood Supratentorial EpendymomaMeningeal MelanocytomaNewly Diagnosed Childhood EpendymomaRecurrent Adult Brain TumorRecurrent Childhood Anaplastic AstrocytomaRecurrent Childhood Anaplastic OligoastrocytomaRecurrent Childhood Anaplastic OligodendrogliomaRecurrent Childhood Brain Stem GliomaRecurrent Childhood Cerebellar AstrocytomaRecurrent Childhood Cerebral AstrocytomaRecurrent Childhood Diffuse AstrocytomaRecurrent Childhood EpendymomaRecurrent Childhood Fibrillary AstrocytomaRecurrent Childhood Gemistocytic AstrocytomaRecurrent Childhood Giant Cell GlioblastomaRecurrent Childhood GlioblastomaRecurrent Childhood Gliomatosis CerebriRecurrent Childhood GliosarcomaRecurrent Childhood MedulloblastomaRecurrent Childhood OligoastrocytomaRecurrent Childhood OligodendrogliomaRecurrent Childhood Pilocytic AstrocytomaRecurrent Childhood Pilomyxoid AstrocytomaRecurrent Childhood PineoblastomaRecurrent Childhood Pleomorphic XanthoastrocytomaRecurrent Childhood Protoplasmic AstrocytomaRecurrent Childhood Subependymal Giant Cell AstrocytomaRecurrent Childhood Supratentorial Primitive Neuroectodermal TumorRecurrent Childhood Visual Pathway and Hypothalamic GliomaRecurrent Childhood Visual Pathway GliomaUntreated Childhood Anaplastic AstrocytomaUntreated Childhood Anaplastic OligodendrogliomaUntreated Childhood Brain Stem GliomaUntreated Childhood Cerebellar AstrocytomaUntreated Childhood Cerebral AstrocytomaUntreated Childhood Diffuse AstrocytomaUntreated Childhood Fibrillary AstrocytomaUntreated Childhood Gemistocytic AstrocytomaUntreated Childhood Giant Cell GlioblastomaUntreated Childhood GlioblastomaUntreated Childhood Gliomatosis CerebriUntreated Childhood GliosarcomaUntreated Childhood MedulloblastomaUntreated Childhood OligoastrocytomaUntreated Childhood OligodendrogliomaUntreated Childhood Pilocytic AstrocytomaUntreated Childhood Pilomyxoid AstrocytomaUntreated Childhood PineoblastomaUntreated Childhood Pleomorphic XanthoastrocytomaUntreated Childhood Protoplasmic AstrocytomaUntreated Childhood Subependymal Giant Cell AstrocytomaUntreated Childhood Supratentorial Primitive Neuroectodermal TumorUntreated Childhood Visual Pathway and Hypothalamic GliomaUntreated Childhood Visual Pathway Glioma
COMPLETED
Vorinostat and Temozolomide in Treating Young Patients With Relapsed or Refractory Primary Brain Tumors or Spinal Cord Tumors
Description

This phase I trial is studying the side effects and best dose of vorinostat when given together with temozolomide in treating young patients with relapsed or refractory primary brain tumors or spinal cord tumors. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may help temozolomide work better by making tumor cells more sensitive to the drug.

COMPLETED
ABT-888 and Temozolomide in Treating Young Patients With Recurrent or Refractory CNS Tumors
Description

This phase I trial is studying the side effects and best dose of ABT-888 when given in combination with temozolomide in treating young patients with recurrent or refractory CNS tumors. ABT-888 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving ABT-888 together with temozolomide may kill more tumor cells.

COMPLETED
Acupressure in Controlling Nausea in Young Patients Receiving Highly Emetogenic Chemotherapy
Description

RATIONALE: Acupressure wristbands may prevent or reduce nausea and caused by chemotherapy. It is not yet known whether standard care is more effective with or without acupressure wristbands in controlling acute and delayed nausea. PURPOSE: This randomized phase III trial is studying how well acupressure wristbands work with or without standard care in controlling nausea in young patients receiving highly emetogenic chemotherapy.

WITHDRAWN
Studying Cerebrospinal Fluid Proteins and Angiogenesis Proteins in Young Patients With Newly Diagnosed Central Nervous System Tumors
Description

RATIONALE: Studying samples of cerebrospinal fluid from patients with cancer in the laboratory may help doctors identify biomarkers related to cancer. PURPOSE: This laboratory study is studying cerebrospinal fluid proteins and angiogenesis proteins in young patients with newly diagnosed central nervous system tumors.

TERMINATED
Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors
Description

RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs in chemotherapy, such as ifosfamide, carboplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving dasatinib together with ifosfamide, carboplatin, and etoposide may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of dasatinib when given together with ifosfamide, carboplatin, and etoposide and to see how well they work in treating young patients with metastatic or recurrent malignant solid tumors.

TERMINATED
MK0752 in Treating Young Patients With Recurrent or Refractory CNS Cancer
Description

RATIONALE: MK0752 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I trial is studying the side effects and best dose of MK0752 in treating young patients with recurrent or refractory CNS cancer.

COMPLETED
Talabostat Combined With Temozolomide or Carboplatin in Treating Young Patients With Relapsed or Refractory Brain Tumors or Other Solid Tumors
Description

RATIONALE: Talabostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving talabostat together with temozolomide or carboplatin may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of talabostat when given together with temozolomide or carboplatin in treating young patients with relapsed or refractory brain tumors or other solid tumors.

COMPLETED
Temozolomide, Vincristine, and Irinotecan in Treating Young Patients With Refractory Solid Tumors
Description

RATIONALE: Drugs used in chemotherapy, such as temozolomide, vincristine, and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan when given together with temozolomide and vincristine in treating young patients with refractory solid tumors.

TERMINATED
Topotecan in Treating Young Patients With Neoplastic Meningitis Due to Leukemia, Lymphoma, or Solid Tumors
Description

RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase I trial is studying the side effects, best way to give, and best dose of topotecan when given by intraventricular infusion in treating young patients with neoplastic meningitis due to leukemia, lymphoma, or solid tumors.

COMPLETED
Valproic Acid in Treating Young Patients With Recurrent or Refractory Solid Tumors or CNS Tumors
Description

RATIONALE: Drugs used in chemotherapy, such as valproic acid, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Valproic acid may also stop the growth of solid tumors or CNS tumors by blocking blood flow to the tumor. PURPOSE: This phase I trial is studying the side effects and best dose of valproic acid in treating patients with recurrent or refractory solid tumors or CNS tumors.

COMPLETED
VNP40101M in Treating Young Patients With Recurrent, Progressive, or Refractory Primary Brain Tumors
Description

RATIONALE: Drugs used in chemotherapy, such as VNP40101M, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase I trial is studying the side effects and best dose of VNP40101M in treating young patients with recurrent, progressive, or refractory primary brain tumors.

COMPLETED
ABT-751 in Treating Young Patients With Refractory Solid Tumors
Description

RATIONALE: Drugs used in chemotherapy, such as ABT-751, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase I trial is studying the side effects of ABT-751 in treating young patients with refractory solid tumors.

COMPLETED
Chemotherapy and Vaccine Therapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation and Interleukin-2 in Treating Patients With Recurrent or Refractory Brain Cancer
Description

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow or peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Vaccines made from a person's white blood cells and tumor cells may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and vaccine therapy followed by bone marrow or peripheral stem cell transplantation and interleukin-2 in treating patients who have recurrent or refractory brain cancer.

COMPLETED
Busulfan in Treating Children and Adolescents With Refractory CNS Cancer
Description

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the safety of delivering intrathecal busulfan in children and adolescents who have refractory CNS cancer and to estimate the maximum tolerated dose of this treatment regimen.

COMPLETED
Rebeccamycin Analogue in Treating Children With Solid Tumors or Non-Hodgkin's Lymphoma
Description

Phase II trial to study the effectiveness of rebeccamycin analogue in treating children who have solid tumors or non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.