Neoplasms

Symptoms and General Pathology

All Conditions

Blood and Lymph Conditions

Immune System Diseases

Behaviors and Mental Disorders

Nervous System Diseases

Rare Diseases

Neoplasm Metastasis

Lymphoma

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Attention Deficit Disorder with Hyperactivity

Brain Neoplasms

Acute Disease

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Disease Attributes

Lymphosarcoma

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

Childhood Acute Lymphoblastic Leukemia

Central Nervous System Stimulants

All Drugs and Chemicals

Cardiotonic Agents

Methylphenidate

Dopamine

Dopamine Uptake Inhibitors

Dopamine Agents

Neurotransmitter Agents

Administered 1 capsule each day for 1 week, .3 mg/kg dose.

Administered 1 capsule each day for 1 week.

1 capsule each day for 1 week, .3 mg/kg dose.

Placebo

Alicia Kunin-Batson, Ph.D.

While neurocognitive impairments in attention, memory and executive functioning are commonly reported sequelae of childhood leukemia and brain tumors, studies have only recently begun to examine the treatment of attention deficits in this population. Numerous studies have examined the effectiveness of methylphenidate in the treatment of children with attention deficit hyperactivity disorder (ADHD). However, the effectiveness of this medication for improving attention and behavioral functioning in children with medical illnesses or brain injury are less clear.

Patients will be randomized to receive one week of Metadate CD (a controlled release form of methylphenidate, similar to Ritalin) and one week of placebo in a double-blind fashion.

Effects of Methylphenidate on Attention Deficits in Childhood Cancer Survivors

Effects of Methylphenidate on Neuropsychological Functioning in Children With Attention Deficits Secondary to Childhood Cancer

Child performance on neuropsychological testing (i.e., using Test of Variables of Attention \[TOVA\] which is a computerized test of attention that assists in the screening, diagnosis, and treatment monitoring of attention disorders, like Attention Deficit Hyperactivity Disorder \[ADHD\], and working memory index of the WisSC IV. Standard scores average = 100 +/- 15. Higher scores indicate better performance. Scores \< or = 1 SD below the mean represent area of deficit.

Parent and teacher ratings of attention, executive function and behavior (i.e., Behavior Rating Inventory of Executive Function \[BRIEF -a parent questionnaire and a teacher questionnaire-designed to assess executive functioning in home and school environments. Conners Parent Rating Scale-3 Short Form \[CPRS-3 research and clinical tool for obtaining parental reports of childhood behavior problems.\] Standard scores average = 50 + or - 10. Higher scores indicate more severe difficulty. Scores \> or = 60 represent areas of significant behavior concern.

Children's Cancer Research Fund United States

University of Minnesota

No patients received treatment, therefore no adverse events were reported.

Participant previously had acute lymphoblastic leukemia or brain tumor to be treated with Methylphenidate or Placebo - Administered 1 capsule each day for 1 week, .3 mg/kg dose.

Participant With Attention Deficit

Age, Categorical

Sex: Female, Male

Only 1 patient was enrolled in this study, no analysis/outcome data can be reported. This patient completed baseline assessment, but withdrew from the study before beginning the medication trial. No medications/placebo were administered.

Alicia Kunin-Batson

No patients received treatment, therefore analysis was not done.

Effectiveness of Methylphenidate on Neurocognitive Components

Changes in Parent and Teacher Ratings of Attention, Executive Functioning and Behavior

Overall Study

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Dermatologic Agents

Aminolevulinic Acid

Photosensitizing Agents

1.5 grams 5-ALA dissolved in 50 ml water, single dose, orally, 2-4 hours prior to surgery

5-aminolevulinic acid (5-ALA)

Hans-Juergen Reulen, MD

The aim of the study "Fluorescence-guided resection of malignant gliomas with 5-Aminolevulinic acid (5-ALA) vs. conventional resection" is to determine how accurately contrast agent-accumulating tumour can be removed by primary surgery and to assess the clinical usefulness of this method.

Malignant gliomas are locally invasive tumors that carry a dismal prognosis despite a combination of surgery, radiotherapy and chemotherapy. Cytoreductive surgery is generally considered beneficial but complete resection of contrast enhancing tumor is achieved in less than 20 % of patients, one reason being the difficulty in discerning marginal, enhancing tumor intraoperatively.

Five-aminolevulinic acid (5-ALA) leads to the accumulation of fluorescent porphyrins in malignant gliomas, a phenomenon under exploration for intraoperative identification and resection of these tumors. This study investigated the benefit derived from fluorescent-guided resections using 5-ALA on surgical radicality, progression-free survival and morbidity.

Fluorescence-guided Resection of Malignant Gliomas With 5-Aminolevulinic Acid

Fluorescence-guided Resection of Malignant Gliomas With 5-Aminolevulinic Acid (5-ALA) vs. Conventional Resection

medac GmbH

Glioblastoma

Astrocytoma

Antineoplastic Agents

Temozolomide

Antineoplastic Agents, Alkylating

Alkylating Agents

Patients will receive trimodal therapy consisting of tumor treating fields therapy with the Optune device concurrent with temozolomide and radiation therapy.

Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM). Treatment will begin approximately 1 week prior to start of radiation and temozolomide treatment and continue concurrently throughout the duration of the study.

Tumor Treating Fields

Patients will be given temozolomide according to routine treatment dosing and schedule.

Patients will be given radiation therapy according to routine treatment dosing and schedule.

Radiation Therapy

Ricky Chen, MD

The study is an open-label pilot study in newly diagnosed glioblastoma patients following surgery. Eligible patients will receive treatment with tumor treating fields therapy using the Optune device starting less than 2 weeks prior to start of chemoradiation. Patients will receive radiation and temozolomide at a routine treatment dose and schedule.

The study is an open-label pilot study in newly diagnosed glioblastoma patients following surgery. Eligible patients will receive treatment with tumor treating fields therapy using the Optune device starting less than 2 weeks prior to start of chemoradiation. Patients will receive radiation and temozolomide at a routine treatment dose and schedule.

The expected toxicity is skin related, and patients will be followed closely with weekly skin and neurological examinations during radiation therapy and for 8 weeks afterwards to capture any delayed toxicity as they begin adjuvant therapy per routine treatment. As long as study treatment is tolerated and their conditions remain stable, patients will continue the treatment for up to 24 months.

Prior to enrollment, an exploratory analysis of radiation dosimetry will be performed by phantom modeling incorporating the Optune arrays. The study incorporates three stages of recruitment to confirm the safety of combining tumor treating fields therapy with concurrent chemoradiation: a safety lead-in cohort of the first 6 patients enrolled, a second safety lead-in cohort of 9 patients, and an expansion cohort with 15 additional patients.

The study is an open-label pilot study. Following surgery, eligible patients will start tumor treating fields therapy with the Optune device less than 2 weeks prior to radiation and temozolomide given at a dose and schedule conforming to routine treatment.

Tumor Treating Fields With Chemoradiation in Newly Diagnosed GBM

Safety and Tolerability of Tumor Treating Fields (TTFields) Combined With Chemoradiation in Newly Diagnosed Glioblastoma (Unity)

Number of patients who experienced a treatment-related adverse event

Number of patients who experienced a treatment-related serious adverse event based on the NCI Common Terminology Criteria for Adverse Events (version 4.03)

Number of patients alive at Day 106 (15 weeks), end of main study period

Number of patients who are progression free at 6 months and 24 months. Progression is defined as any of the following: greater than or equal to 25% increase in sum of lesions compared with smallest tumor measurement obtained, significant increase in T2/FLAIR non-enhancing lesions, any new lesion, clear clinical deterioration not attributable to other causes, or clear progression of non-measureable disease.

University of California, San Francisco

NovoCure Ltd.

Providence Health & Services

Participants who finished the DLT period and were assessed by investigators

Safety lead-in Cohort

Age, Continuous

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

The Karnofsky Performance Scale Index allows patients to be classified as to their functional impairment. This can be used to compare effectiveness of different therapies and to assess the prognosis in individual patients. The lower the Karnofsky score, the worse the survival for most serious illnesses.

Karnofsky Performance Scale (KPS)

Newly diagnosed patients histologically confirmed glioblastoma after maximally safe resection

Early termination leading to small numbers of subjects analyzed

Chiayi Chen / Director of PBSI and WC Clinical Research Program

Rate of Treatment-Related Adverse Events Associated With Trimodal Therapy

Severity of Treatment-Related Adverse Events Associated With Trimodal Therapy

Overall Survival Rate

Progression-free Survival at 6 Months and 24 Months

Seizures

Neurologic Manifestations

Anticonvulsants

Nootropic Agents

Levetiracetam

Levetiracetam taken by mouth at a daily dose of 1000 mg for one week.

Levetiracetam taken by mouth at a daily dose of 1000 mg for six weeks.

Maryam Rahman, MS, MD

The purpose of this study is to see if there are any differences in patient reported neurotoxicity between patients who receive Levetiracetam tablets for one week after surgery to remove a brain tumor versus those who receive Levetiracetam tablets for six weeks after surgery. Specifically, we will see if one group has less side effects than the other, and whether or not one group has more seizures than the other.

Because seizures are one of the leading neurologic complications in brain tumor patients, neurosurgeons prescribe antiepileptic drugs (AEDs) to help prevent them. Although the American Academy of Neurology (AAN) guidelines recommend that AEDs be stopped after the first post-operative week in patients without seizures, there is no standard length of treatment and some patients may stay on AEDs indefinitely.

In an attempt to develop clinical guidelines for AED use in post-operative brain tumor patients, we will try to determine if taking levetiracetam for 1 week results in less neurotoxicity than taking it for 6 weeks.

1 Week Versus 6 Weeks of Levetiracetam in Surgical Brain Tumor Patients

A Shortened Antiepileptic Drug (AED) Course in Surgical Brain Tumor Patients: A Randomized Trial

The Neurotoxicity Scale is as a validated 27 question, patient-reported measure for assessing the adverse effects of antiepileptic drugs on cognitive function. Patients self-report "no problem", "a mild problem", "a moderate problem" or "a serious problem" for each question corresponding to a score of 0, 1, 2, and 3, respectively. For each patient, the overall score was formed by summing scores in all 27 questions. The minimum possible score is 0 and the maximum possible total score is 81. A lower score indicates less toxicity when taking an antiepileptic drug. The outcome is a score change from baseline at the 6 week follow-up and is calculated by subtracting the baseline score from the 6 week follow-up score for each patient.

University of Florida

Participants at risk for all-cause mortality included any participant who signed consent to take part in the study. Participants at risk for Serious Adverse Events and Other (not including serious) Adverse Events included only participants who received study intervention.

Levetiracetam taken by mouth at a daily dose of 1000 mg for one week.

Levetiracetam

1 Week Levetiracetam

Levetiracetam taken by mouth at a daily dose of 1000 mg for six weeks.

Levetiracetam

6 Week Levetiracetam

Total

Percent of subjects that are male or female.

Percentage of participants identifying as a particular ethnicity in each arm

Percentage of participants identifying as a particular race in each arm

Subjects were screened against eligibility criteria. Subjects with a history of seizures, depression or use of psychiatric medications, Beck-Depression Inventory score over 14, biopsy only or other factors were determined ineligible. Potential participants who may have been eligible also declined participation.

Kristine Wynne

All patients taking levetiracetam 1000 mg daily, not stratified by dosing schedule.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effects of Methylphenidate on Attention Deficits in Childhood Cancer Survivors	NCT01100658	ALL, Childhood Leukemia, Lymph... Leukemia, Lymph... Leukemia, Lymph... Leukemia, Lymph... Leukemia, Lymph... Leukemia, Lymph... Leukemia, Lymph... Leukemia, Lymph... Lymphoblastic L... Lymphoblastic L... Lymphoblastic L... Lymphoblastic L... Lymphoblastic L... Lymphoblastic L... Lymphocytic Leu... Lymphocytic Leu... Lymphocytic Leu... Brain Tumors Cancer of the B... Cancer of Brain Malignant Prima... Brain Neoplasms...	Methylphenidate Placebo	8 Years - 17 Years	University of Minnesota
Fluorescence-guided Resection of Malignant Gliomas With 5-Aminolevulinic Acid	NCT00241670	Brain Cancer Brain Tumors Cancer of Brain Primary Brain T... Brain Tumor, Pr...	5-aminolevulini...	18 Years - 72 Years	medac GmbH
Fluorescence-guided Resection of Malignant Gliomas With 5-Aminolevulinic Acid	NCT00241670	Brain Cancer Brain Tumors Cancer of Brain Primary Brain T... Brain Tumor, Pr...	5-aminolevulini...	18 Years - 72 Years	medac GmbH
Effects of Methylphenidate on Attention Deficits in Childhood Cancer Survivors	NCT01100658	ALL, Childhood Leukemia, Lymph... Leukemia, Lymph... Leukemia, Lymph... Leukemia, Lymph... Leukemia, Lymph... Leukemia, Lymph... Leukemia, Lymph... Leukemia, Lymph... Lymphoblastic L... Lymphoblastic L... Lymphoblastic L... Lymphoblastic L... Lymphoblastic L... Lymphoblastic L... Lymphocytic Leu... Lymphocytic Leu... Lymphocytic Leu... Brain Tumors Cancer of the B... Cancer of Brain Malignant Prima... Brain Neoplasms...	Methylphenidate Placebo	8 Years - 17 Years	University of Minnesota
Tumor Treating Fields With Chemoradiation in Newly Diagnosed GBM	NCT03705351	Glioblastoma Cancer of Brain Glioblastoma Mu... Brain Tumor	Tumor Treating ... Temozolomide Radiation Thera...	22 Years -	Providence Health & Services
1 Week Versus 6 Weeks of Levetiracetam in Surgical Brain Tumor Patients	NCT02334722	Brain Neoplasms Brain Cancer Brain Tumors Cancer of the B... Cancer of Brain Seizure	Levetiracetam	18 Years -	University of Florida

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