Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04553757
Other study ID # 2020-0124
Secondary ID NCI-2020-0651020
Status Active, not recruiting
Phase
First received
Last updated
Start date July 8, 2020
Est. completion date December 30, 2025

Study information

Verified date April 2024
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study investigates how seizures can vary over time with changes in low grade gliomas and its treatments. This study may help doctors find symptoms or triggers of seizures earlier than normal, and ultimately earlier care or treatment for seizures.


Description:

PRIMARY OBJECTIVE: I. To evaluate the rate of change of seizure frequency and the status of the tumor at each data collection point. SECONDARY OBJECTIVES: I. To obtain sufficient number of patients' data in order to power the analysis to determine whether a change in seizure frequency correlates with tumor control. II. Evaluate progression free survival and overall survival when compared with seizure control. OUTLINE: Patients complete a seizure assessment survey over 5 minutes at each clinic visit.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 100
Est. completion date December 30, 2025
Est. primary completion date December 30, 2025
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Adult patients - Primary brain tumors (separated by World Health Organization [WHO] grade I-IV) - History of seizures secondary to brain tumor - On tumor directed treatment - Magnetic resonance imaging (MRI) within 2 weeks of clinic visit where seizure assessment takes place Exclusion Criteria: - Patients without seizures - Patients with intracranial lesions other than primary brain tumor - Patients not undergoing tumor directed treatment - Absence of recent (within 2 weeks) MRI

Study Design


Intervention

Other:
Survey Administration
Complete survey

Locations

Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of change of seizure frequency Both average composite scores as well as individual question scores from the seizure survey will be evaluated. Will perform descriptive statistics to characterize the demographic and disease-related features of this population. Will perform regression analyses to the relationship of survey results to clinical and radiographic features. Cox regression analyses for other relevant post-hoc analyses may be performed. Baseline to 2 years
Primary Status of tumor Radiographic information will be derived from brain MRIs performed on each patient at time of diagnosis, and subsequently at times of survey administration. Will perform descriptive statistics to characterize the demographic and disease-related features of this population. Will perform regression analyses to the relationship of survey results to clinical and radiographic features. Cox regression analyses for other relevant post-hoc analyses may be performed. Up to 2 years
Secondary Patient data collection Will obtain sufficient number of patients' data in order to power the analysis to determine whether a change in seizure frequency correlates with tumor control. Clinical information to be extracted from the medical record includes but not limited to; date of birth, gender, date of diagnosis, clinical symptoms referable to the brain tumor, functional status and age at diagnosis, treatments applied, dates of progression, and date of death. Radiographic information will be derived from brain MRIs performed on each patient at time of diagnosis, and subsequently at times of survey administration. Will perform descriptive statistics to characterize the demographic and disease-related features of this population. Up to 2 years
Secondary Progression-free survival (PFS) Will evaluate PFS when compared with seizure control. Up to 2 years
Secondary Overall survival (OS) Will evaluate OS when compared with seizure control. Up to 2 years
See also
  Status Clinical Trial Phase
Completed NCT00001972 - PET Scan of Brain Metabolism in Relation to Age and Disease N/A
Completed NCT02798406 - Combination Adenovirus + Pembrolizumab to Trigger Immune Virus Effects Phase 2
Terminated NCT02855086 - Cetuximab-IRDye 800CW in Detecting Tumors in Patients With Malignant Glioma Undergoing Surgery Phase 1/Phase 2
Terminated NCT00638963 - Temozolomide as a Prophylaxis Against Brain Recurrence in Participants With Metastatic Breast Cancer (P05225 AM2) Phase 2
Withdrawn NCT03234309 - Ferumoxytol in Magnetic Resonance Imaging of Pediatric Patients With Brain Tumors Phase 2
Completed NCT00178295 - Radiation-Induced Cytokine Cascades and Their Correlation With Central Nervous System Injury N/A
Recruiting NCT04810871 - Surgical Resection of Latent Brain Tumors Prior to Recurrence N/A
Recruiting NCT02800486 - Super Selective Intra-arterial Repeated Infusion of Cetuximab (Erbitux) With Reirradiation for Treatment of Relapsed/Refractory GBM, AA, and AOA Phase 2
Completed NCT01621295 - Assessing the Patient Experience in Cancer Care N/A
Completed NCT02964416 - Single Dose Tramadol Effect on Extubation Response and Quality of Emergence Post-supratentorial Intracranial Surgery Phase 4
Completed NCT00001574 - A Pilot Study of 1H-Nuclear Magnetic Resonance Spectroscopic Imaging in Pediatric Patients With Primary and Metastatic Brain Tumors
Recruiting NCT02861898 - Super-selective Intra-arterial Repeated Infusion of Cetuximab for the Treatment of Newly Diagnosed Glioblastoma Phase 1/Phase 2
Completed NCT00040573 - Safety and Tolerability Study of 131I-TM-601 to Treat Adult Patients With Recurrent Glioma. Phase 1/Phase 2
Recruiting NCT02754544 - Electrocorticography in Mapping Functional Brain Areas During Surgery in Patients With Brain Tumors N/A
Recruiting NCT03216148 - 18F-FET PET in Childhood Brain Tumours Phase 2
Completed NCT00001171 - Evaluation of Factors in Human Brain Tumors N/A
Withdrawn NCT01413438 - Bevacizumab With or Without Surgery for Adult Glioblastomas Phase 2
Not yet recruiting NCT05516485 - Measuring Brain Tumor Consistency Using Magnetic Resonance Elastography N/A
Recruiting NCT02639325 - Tumor Related Epilepsy
Recruiting NCT02672995 - Fractionated Stereotactic Radiosurgery With Concurrent Bevacizumab for Brain Metastases: A Phase I Dose-escalation Trial Phase 1