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Alkylating agent
Carmustine + Surgery for Brain Cancer
Phase 1 & 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
Histologically confirmed recurrent supratentorial malignant glioma with clear evidence of progression by MRI
Performance status: Karnofsky 60-100%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing a new treatment for brain cancer that involves surgery after chemotherapy.
Who is the study for?
This trial is for adults aged 18-75 with recurrent malignant glioma or metastatic brain tumors, who are in good physical condition and have not had recent chemotherapy or radiotherapy. Participants must be able to undergo surgery, have a certain tumor size and shape, and cannot be pregnant. They should also not have any severe medical conditions that could interfere with the study.Check my eligibility
What is being tested?
The trial is testing the effectiveness of carmustine, a chemotherapy drug, followed by surgical removal of the tumor. It aims to see if this treatment can stop tumor cells from growing or cause them to die in patients with specific types of brain tumors that have come back after previous treatments.See study design
What are the potential side effects?
Carmustine can potentially cause side effects such as nausea, vomiting, fatigue, hair loss, liver problems (indicated by changes in blood tests), low blood counts which might increase infection risk or bleeding tendency. The severity of side effects may vary among individuals.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My brain tumor has grown again, confirmed by an MRI.
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I can care for myself but may not be able to do active work.
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I am scheduled for my first surgery to remove a recurring tumor.
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I do not have any ongoing infections that aren't under control.
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I do not have a fever, or if I do, it's because of my cancer.
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I am between 18 and 75 years old.
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My liver function tests are within normal limits.
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My tumor is between 4 and 33.4 cm3 in size.
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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood counts must be normal, and you should not have any tendency to bleed easily.My condition is anaplastic ependymoma.My condition is anaplastic astrocytoma.I have been diagnosed with anaplastic oligodendroglioma.My tumor is not divided into 3 or more parts.I have had surgery before.My brain tumor has grown again, confirmed by an MRI.I can care for myself but may not be able to do active work.It's been over 4 weeks since my last radiotherapy and I've recovered.I haven't had radiotherapy for cancer in the last 12 weeks unless my tumor grew over 25%.My tumor has a thick, enhancing rim around a central dead or cystic area.My kidney function tests are within the required range.I do not have any ongoing infections that aren't under control.My cancer has not spread to certain areas of my brain.It's been over 4 weeks since my last chemotherapy, and I've recovered.I haven't had surgery to remove a tumor within the last 12 weeks.I do not have a fever, or if I do, it's because of my cancer.I haven't had chemotherapy in the last 12 weeks, unless my tumor grew more than 25%.I am scheduled for my first surgery to remove a recurring tumor.I do not have any severe or unstable health conditions.My tumor has not been cut into or punctured.I am between 18 and 75 years old.You need to have a negative pregnancy test.I have been diagnosed with glioblastoma multiforme.I have never had radiation therapy inside my skull.My tumor's shape allows for even drug distribution.My tumor is round or egg-shaped.My liver function tests are within normal limits.My cancer has not spread into my brain's ventricular system.My cancer has spread to my brain, but it's not melanoma.My tumor is between 4 and 33.4 cm3 in size.I am not taking any blood thinners.I don't have any health or mental issues that would stop me from joining the study.
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 opportunities for participants to join this clinical trial right now?
"According to clinicaltrials.gov, this trial is no longer recruiting participants; it was originally posted on the 1st June 2000 and last updated November 5th 2013. Nonetheless, there are currently 2859 active studies that invite interested parties to apply."
Answered by AI
Does the age criteria of this experiment encompass individuals over 45?
"This clinical trial requires applicants to be between 18 and 75 years of age. Separately, there are 435 trials for minors and 2564 studies available for those over the retirement threshold."
Answered by AI
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