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SVZ Radiation + Temozolomide for Glioblastoma
Phase 2
Recruiting
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
ECOG performance status 0-2 (Karnofsky >60%).
Patient must be scheduled to receive temozolomide concurrent with and following radiation.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year post completion of radiation treatment
Awards & highlights
Study Summary
This trial is testing a new radiation technique to see if it can better control glioblastoma, a type of brain cancer.
Who is the study for?
This trial is for adults with newly diagnosed Glioblastoma Multiforme (GBM) who've had surgery but no brain radiation before. They must start treatment within 12 weeks of surgery, have a performance status allowing daily activities with effort or better, and agree to use contraception. Pregnant women, those unwilling to prevent pregnancy, and patients with other serious illnesses or prior cancers (except certain skin cancers and treated cervical cancer) are excluded.Check my eligibility
What is being tested?
The study tests if targeting the subventricular zone (SVZ)—a brain area containing stem cells—with higher-dose radiation alongside standard chemotherapy (Temozolomide), can control GBM longer than standard therapy alone. Patients will receive this modified radiation plan over six weeks to see if it improves outcomes.See study design
What are the potential side effects?
Potential side effects include typical reactions from radiation such as fatigue, hair loss at the treatment site, headaches, nausea; and from Temozolomide like nausea, vomiting, constipation, loss of appetite and risk of infections due to lowered blood cell counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can care for myself and am up more than 50% of my waking hours.
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I am scheduled for treatment with temozolomide alongside and after radiation.
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I have been recently diagnosed with glioblastoma.
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I have never had radiation therapy to my brain.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year post completion of radiation treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year post completion of radiation treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from Baseline to Initial Progression
Secondary outcome measures
Acute and Late Toxicity Change from Baseline
Cognitive Function Change from Baseline
Composite Cognitive Function Change from Baseline
+9 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Temozolomide plus radiation therapy to the tumor and SVZExperimental Treatment2 Interventions
Patients will be scheduled to receive continuous daily temozolomide (75 mg per square meter of body surface area per day, 7 days per week from the first to the last day of radiation therapy), followed by 6 cycles of adjuvant temozolomide (150 to 200 mg per square meter for 5 days during each 28 day cycle).
Patients will receive 60 Gy of radiation therapy in 30 fractions, 5 days per week using IMRT. The target delineation and treatment volumes will be as follows:
Initial treatment plan will include the tumor bed and MRI changes based on T1 post gadolinium series and FLAIR series, plus the bilateral subventricular zone Will be prescribed to 46 Gy in 2 Gy fractions
Cone down treatment plan will include the tumor bed, areas of contrast enhancement on T1 post gadolinium series MRI plus the ipsilateral subventricular zone Will be prescribed to 14 Gy in 2 Gy fractions
Group II: Temozolomide and neural progenitor cell sparing radiationActive Control2 Interventions
Patients will receive continuous daily temozolomide (75 mg per square meter of body surface area per day, 7 days per week from the first to the last day of radiation therapy), followed by 6 cycles of adjuvant temozolomide (150 to 200 mg per square meter for 5 days during each 28 day cycle).
Patients will receive 60 Gy in 30 fractions, 5 days per week using IMRT. The target delineation and treatment volumes will be as follows:
Initial treatment plan will include the tumor bed and MRI abnormalities based on T1 post gadolinium series and FLAIR series.
Will be prescribed to 46 Gy in 2 Gy fractions
Cone down treatment plan will include the tumor bed and MRI changes based on T1 post gadolinium series.
Will be prescribed to 14 Gy in 2 Gy fractions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Temozolomide
FDA approved
Find a Location
Who is running the clinical trial?
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
558 Previous Clinical Trials
32,859 Total Patients Enrolled
31 Trials studying Glioblastoma
923 Patients Enrolled for Glioblastoma
Kristin Redmond, M.D.Principal InvestigatorThe SKCCC at Johns Hopkins
4 Previous Clinical Trials
119 Total Patients Enrolled
2 Trials studying Glioblastoma
64 Patients Enrolled for Glioblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years or older and have been diagnosed with GBM.I have not used Avastin or any VEG-F inhibitor before my cancer progressed.I had surgery for my brain tumor and will start radiation within 12 weeks post-surgery.I can care for myself and am up more than 50% of my waking hours.I am scheduled for treatment with temozolomide alongside and after radiation.My radiation therapy is scheduled to start within 3 months after my surgery.I am not pregnant or breastfeeding and will use birth control during and up to 12 weeks after the study.I have been recently diagnosed with glioblastoma.I do not have any severe illnesses that could interfere with the study.I have never had radiation therapy to my brain.I can understand and am willing to sign the consent form.I am not pregnant and agree to use contraception during and up to 12 weeks after the study.I have no cancer history, except for certain skin cancers, cervical pre-cancer, or any cancer I've been free from for 2+ years.
Research Study Groups:
This trial has the following groups:- Group 1: Temozolomide and neural progenitor cell sparing radiation
- Group 2: Temozolomide plus radiation therapy to the tumor and SVZ
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are some potential side effects of Temozolomide?
"Temozolomide received a safety score of 2. This is due to it being in Phase 2 clinical trials, where there is some evidence of its safety but not yet any efficacy data."
Answered by AI
To be eligible for this test, what do participants have to meet?
"This clinical study is testing a new treatment for glioblastoma in patients aged 18 to 100. They are looking to enroll around 60 people in total."
Answered by AI
How many participants are being recruited for this trial?
"The clinical trial is recruiting patients, as the information available on clinicaltrials.gov indicates. This particular trial was posted on 7/8/2014 and updated on 10/25/2022; it is looking for 60 participants who will be seen at 3 different locations."
Answered by AI
Could you please summarize the prior research on Temozolomide?
"Memorial Sloan Kettering Cancer Center first evaluated temozolomide in 2002 and, since then, there have been 296 completed studies. There are currently 218 ongoing clinical trials with a large portion of these being conducted in Baltimore, District of Columbia."
Answered by AI
Does this research cater to elderly individuals?
"This trial is open to individuals that are 18-100 years old, with 80 other clinical trials targeting those under 18 and 613 for people over 65."
Answered by AI
What other similar studies has this been compared to?
"As of right now, there are 218 Temozolomide trials ongoing in 947 cities across 36 countries. The first such study was sponsored by Schering-Plough and completed Phase 2 drug approval in 2002 with 60 participants. In the 18 years since then, 296 moreTemozolomide trials have been carried out to completion."
Answered by AI
What are the most common ailments that Temozolomide is used to combat?
"Temozolomide is not only effective in treating nitrosourea resistance, but also other conditions such as mycosis fungoides and refractory neuroblastoma."
Answered by AI
Can people with certain medical conditions participate in this research?
"From what is published on clinicaltrials.gov, it seems that this particular trial is still recruiting patients. The listing was first put up on 7/8/2014 and updated as recently as 10/25/2022."
Answered by AI
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