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Low Dose Fractionated Radiation Therapy (LDFRT) for Brain Tumor
Phase 2
Waitlist Available
Led By Kristin Redmond, M.D.
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must be at least 12 months from completion of radiation therapy
Age >18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6 and 12 month follow-up after therapy has been completed
Awards & highlights
Study Summary
This trial will test the safety and effectiveness of low dose rate radiation therapy plus temozolomide in patients with High Grade Glioma who have previously been treated with surgery and radiation therapy.
Eligible Conditions
- Brain Tumor
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You have previously undergone surgical resection (any extent okay) and adjuvant radiation therapy plus temozolomide.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately every month from study start until 48 weeks, and then up to 12 months after completion of temozolomide at 3, 6, and 12 months follow up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately every month from study start until 48 weeks, and then up to 12 months after completion of temozolomide at 3, 6, and 12 months follow up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival Rate
Response Rate
Secondary outcome measures
Number of Patients With Hematologic Toxicities
Number of Patients With Neurologic Toxicity
Progression Free Survival Rate
Side effects data
From 2022 Phase 2 trial • 31 Patients • NCT0146668663%
Death (Disease Progression)
20%
Lymphocyte Count Decreased
13%
Death (NOS)
13%
Disease Progression
10%
Weakness (lower extremity)
10%
Pulmonary Embolism
10%
Cognitive Disturbance
10%
Fatigue
7%
Speech Impairment
7%
Seizure
7%
ALT increased
7%
Ambulatory Dysfunction / Inability to Walk
7%
DVT (NOS)
7%
Hyperglycemia / Elevated Glucose
7%
Motor Neuropathy
3%
Pain (lower back)
3%
Shortness of Breath
3%
Intraparenchymal Hemorrhage of Brain
3%
Lymphocyte Count Decrease
3%
Tinnitus
3%
Urinary Incontinence
3%
Pain (knee)
3%
Pain (NOS)
3%
Platelet Count Decreased
3%
Status Epilepticus
3%
Personality/Behavioral CTC
3%
Aphasia
3%
Bowel Incontinence
3%
DVT (RLE)
3%
Headache
3%
Leukocytosis
3%
Lymphopenia
3%
Memory Loss
3%
Nausea
3%
Ocular-Visual
3%
Weakness (NOS)
100%
80%
60%
40%
20%
0%
Study treatment Arm
Temozolomide With Low Dose Fractionated Radiation Therapy
Trial Design
1Treatment groups
Experimental Treatment
Group I: Temozolomide with Low Dose Fractionated Radiation TherapyExperimental Treatment2 Interventions
All patients will receive temozolomide (150 to 200 mg per square meter for 5 days during each 28 day cycle) for a total of 1 year or until the time of disease progression.
All patients will receive 0.5 Gy of radiation therapy twice daily. This study will include a safety run-in component. If > 33% of patients in the initial cohort of 6 experience grade 3 or greater hematologic toxicity according to the NCI Common Toxicity Criteria version 4, then a dose reduction will occur following the schedule listed below. Otherwise, following a 1 month waiting period after the first cycle of adjuvant LDFRT plus temozolomide for the first cohort of patients, the phase 2 study will open for full accrual. Patients will receive radiation with the first six 28-day cycles of temozolomide.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Temozolomide
2010
Completed Phase 3
~1930
Low Dose Fractionated Radiation Therapy (LDFRT)
2012
Completed Phase 2
~40
Find a Location
Who is running the clinical trial?
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
554 Previous Clinical Trials
32,880 Total Patients Enrolled
Kristin Redmond, M.D.Principal InvestigatorJohns Hopkins University
4 Previous Clinical Trials
148 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
What portion of applicants met pre-screening criteria?
Met criteria
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