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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
Must not have
No prior anticoagulants
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not taken any blood thinners before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Find a Location

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

Carmustine (Alkylating agent) Clinical Trial Eligibility Overview. Trial Name: NCT00006656 — Phase 2
Brain Tumor Research Study Groups:
Brain Tumor Clinical Trial 2023: Carmustine Highlights & Side Effects. Trial Name: NCT00006656 — Phase 2
Carmustine (Alkylating agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00006656 — Phase 2
~14 spots leftby Sep 2025
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