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Alkylating agent
Carmustine for Glioblastoma
Phase 2
Waitlist Available
Research Sponsored by Direct Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No tumor extension into the ventricular system
Histologically proven supratentorial malignant glioblastoma multiforme
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is studying how well carmustine works in treating patients with progressive or recurrent glioblastoma multiforme.
Who is the study for?
This trial is for adults aged 18-75 with recurrent glioblastoma multiforme, a type of brain tumor. Participants must have had prior radiotherapy, be in good physical condition (Karnofsky score 60-100%), and not be pregnant or nursing. They should have no severe infections, controlled blood counts and liver/kidney function, and agree to use contraception.Check my eligibility
What is being tested?
The study is testing the effectiveness of carmustine, a chemotherapy drug, on patients with progressive or recurrent glioblastoma multiforme. It's a Phase II trial focusing on how well this treatment can stop tumor cells from growing or causing them to die.See study design
What are the potential side effects?
Carmustine may cause side effects such as nausea, vomiting, fatigue, hair loss, skin rash and more serious ones like lung problems or bone marrow suppression which could lead to increased risk of infection or bleeding.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has not spread into the brain's ventricular system.
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I have been diagnosed with a specific brain cancer called glioblastoma.
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I can care for myself but may not be able to do active work.
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My brain condition does not affect my main sensory or motor areas, vision, or other cranial nerves.
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My cancer has not spread to the brainstem or midbrain.
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I have undergone radiotherapy at least once.
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I am between 18 and 75 years old.
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My tumor is smaller than 33.4 cm3.
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My liver function tests are within normal limits.
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My kidney function tests are within the required range.
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My tumor cannot be removed surgically and is round in shape.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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Who is running the clinical trial?
Direct TherapeuticsLead Sponsor
2 Previous Clinical Trials
39 Total Patients Enrolled
Gene David Resnick, MDStudy ChairMillennix
1 Previous Clinical Trials
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has not spread into the brain's ventricular system.I have been diagnosed with a specific brain cancer called glioblastoma.I can care for myself but may not be able to do active work.I have not taken any blood thinners before.My brain condition does not affect my main sensory or motor areas, vision, or other cranial nerves.My tumor has a thick outer layer, even if it's partly hollow or dead inside.My cancer has not spread to the brainstem or midbrain.I have undergone radiotherapy at least once.I am between 18 and 75 years old.My tumor is smaller than 33.4 cm3.My liver function tests are within normal limits.My kidney function tests are within the required range.My tumor cannot be removed surgically and is round in shape.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Are there any current vacancies in this clinical trial's research subjects?
"No, this particular trial is not recruiting patients right now. The listing on clinicaltrials.gov shows that the last date this study was edited was November 5th, 2013. It's worth mentioning that there are 560 other trials which are currently looking for participants."
Answered by AI
Are there any hospitals in North America running this clinical trial?
"Currently, there are 12 sites enrolling patients for this trial. The locations of these centres are in Atlanta, Stanford, Los Angeles and 9 other cities. To limit the amount of travel required, it is best to select a location closest to you."
Answered by AI
Are young adults eligible for this experiment?
"This clinical trial is only seeking patients aged 18 to 75. Out of the 579 total trials, 106 are for minors and 473 are for senior citizens."
Answered by AI
What harmful side effects have been most commonly associated with this medication?
"While there is some data supporting the safety of this phase 2 treatment, none of it speaks to efficacy. Our team at Power have given it a score of 2."
Answered by AI
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