Neoplasms

Nervous System Diseases

All Conditions

Behaviors and Mental Disorders

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Quality of Life

PROMIS pediatric domains for emotional distress (anxiety and depression), physical function (fatigue, pain interference, mobility and upper extremity), and peer relations

PROMIS adult domains. To reduce respondent burden, the multi-form design will be used which includes the short form of physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference and pain intensity.

Parent/guardian will complete the parental proxy PROMIS instruments based on corresponding child age (ages 5 to 17 years)

PROMIS questionnaires completed every 3 months for up to 2 years.

PROMIS-QOL

Mariko DeWire, MD

In this research study the investigators want to learn more about the quality of life before, during and after cancer treatment in patients with central nervous system brain tumors. Often CNS tumors and cancer treatment can cause many physical and emotional problems and side effects. Some of these problems and treatment side effects can cause a change in a patient's qualify of life and overall well-being. Quality of life questionnaires are used to measure well-being and ability to carry out daily activities by asking patients to answer several questions about their physical, emotional, and social well-being.

In this research study we want to find out if patient's answers to these questions change over the course of your treatment. We also want to see if doctors and nurses can use these answers to the questions to help patients feel better and increase their activity during cancer treatment.

Pediatric CNS tumors are the second most common form of pediatric cancer and the leading cause of death related to pediatric malignancies. Over decades of work and through the efforts of collaborative groups, cure rates have increased significantly. However, various types of CNS malignancy outcomes have remained stagnant. Moreover, side effects from treatments of even the most curable CNS tumors may have dramatic short and long-term sequela ranging from cognitive, endocrine malfunction, functional mobility, neurological, and ophthalmologic compromises. As science and protocol directed therapies continue to find cures for these patients, work also must continue in efforts to explore patient reported outcomes (PROs) and health related quality of life (HRQOL) throughout the trajectory of a patient's disease process. Increased efforts in patient reported outcomes will lead to improvements in symptom management, functional status, and overall quality of life (QOL).

Health Related Quality of Life in Pediatric Central Nervous System (CNS) Tumors: A Feasibility Study Utilizing PROMIS

Alex's Lemonade Stand Foundation

Children's Hospital Medical Center, Cincinnati

Symptoms and General Pathology

Rare Diseases

Recurrence

Glioma

Astrocytoma

Disease Attributes

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Anaplastic Astrocytoma

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Amino Acids

Temozolomide

Lomustine

Eflornithine

Antineoplastic Agents, Alkylating

Alkylating Agents

Antiprotozoal Agents

Antiparasitic Agents

Enzyme Inhibitors

Ornithine

Eflornithine dosed on a 2 weeks on, 1 week off schedule + Lomustine dosed every 6 weeks

Eflornithine 2.8 g/m2 administered orally every 8 hours on a 2 week on, 1 week off schedule

Lomustine 90 mg/m2 administered orally once every 6 weeks

Lomustine 110 mg/m2 administered orally once every 6 weeks

The purpose of this study is to compare the efficacy and safety of eflornithine in combination with lomustine, compared to lomustine taken alone, in treating patients whose anaplastic astrocytoma has recurred/progressed after radiation and temozolomide chemotherapy.

This study will consist of 4 study periods of up to 50 months in total, consisting of:

Screening Period - A maximum screening duration of 4 weeks.

Treatment Period - Treatment Arm A up to 24 months; Treatment Arm B up to 12 months.

End of Treatment Visit - A minimum of 4 weeks post last treatment for both arms.

Follow-Up Period - Up to approximately 36 months, or until patient death.

A total of approximately 340 patients will be randomized in a 1:1 ratio to receive either eflornithine + lomustine or lomustine alone.

Study to Evaluate Eflornithine + Lomustine vs Lomustine in Recurrent Anaplastic Astrocytoma (AA) Patients

A Randomized Phase 3 Open-Label Study To Evaluate the Efficacy and Safety of Eflornithine With Lomustine Compared to Lomustine Alone in Patients With AA That Progress/Recur After Irradiation and Adjuvant Temozolomide Chemotherapy

Orbus Therapeutics, Inc.

Glioblastoma

Only Arm. Patients treated using AutoLITT System.

AutoLITT system

Gene Barnett, MD

Andrew Sloan, MD

The main purpose of this study is to evaluate the safety and performance of the AutoLITT system for the treatment of recurrent/progressive glioblastoma multiforme tumors (GBM).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Health Related Quality of Life in Pediatric Central Nervous System (CNS) Tumors: A Feasibility Study Utilizing PROMIS	NCT02603692	Brain Neoplasms	PROMIS-QOL	5 Years - 35 Years	Children's Hospital Medical Center, Cincinnati
Study to Evaluate Eflornithine + Lomustine vs Lomustine in Recurrent Anaplastic Astrocytoma (AA) Patients	NCT02796261	Anaplastic Astr... Recurrent Anapl...	Eflornithine Lomustine Lomustine	18 Years -	Orbus Therapeutics, Inc.
Monteris AutoLITT™ FIM Safety Trial for Recurrent/Progressive Brain Tumors	NCT00747253	Brain Tumor Brain Tumor, Re... Brain Neoplasm Brain Cancer Glioblastoma Mu... Recurrent Gliob...	AutoLITT system	18 Years -	Monteris Medical
Health Related Quality of Life in Pediatric Central Nervous System (CNS) Tumors: A Feasibility Study Utilizing PROMIS	NCT02603692	Brain Neoplasms	PROMIS-QOL	5 Years - 35 Years	Children's Hospital Medical Center, Cincinnati
Study to Evaluate Eflornithine + Lomustine vs Lomustine in Recurrent Anaplastic Astrocytoma (AA) Patients	NCT02796261	Anaplastic Astr... Recurrent Anapl...	Eflornithine Lomustine Lomustine	18 Years -	Orbus Therapeutics, Inc.

Spots Global Cancer Trial Database for progressive brain tumor