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Alkylating agents

Standard Care + Photodynamic Therapy for Brain Tumor

Phase 3
Waitlist Available
Research Sponsored by Colorado Health Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Grade 3 or 4 astrocytoma as defined by the Daumas-Duport classification
Renal criteria: Creatinine no greater than 2 mg/dL
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is studying adding photodynamic therapy to surgery, radiation therapy, and chemotherapy in treating patients with newly diagnosed or recurrent malignant supratentorial gliomas.

Who is the study for?
This trial is for adults with a specific brain tumor called malignant supratentorial glioma, either newly diagnosed or recurrent. Candidates should be fit for surgery based on scans and have a decent quality of life score (Karnofsky performance status). They must not be pregnant or nursing, have acceptable kidney function, and if the tumor has come back, they need to have tried surgery and radiation before without success.Check my eligibility
What is being tested?
The study is testing whether adding photodynamic therapy—which uses light-sensitive drugs to destroy cancer cells—to standard treatment (surgery, radiation therapy, chemotherapy) improves outcomes in patients with these aggressive brain tumors. Participants are randomly assigned to receive either the combined standard treatments alone or with additional photodynamic therapy.See study design
What are the potential side effects?
Potential side effects include those from surgery (like infection), radiation therapy (such as skin irritation and fatigue), chemotherapy-related issues like nausea and hair loss. Photodynamic therapy may cause sensitivity to light among other unique reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My brain tumor is classified as a high-grade astrocytoma.
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My creatinine levels are 2 mg/dL or lower.
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I am 18 years old or older.
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My liver function tests are within the required limits.
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My brain tumor is confirmed as glioblastoma or malignant astrocytoma.
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My cancer came back after both surgery and radiation failed.
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I can care for myself but may not be able to do active work (new diagnosis) or I am able to care for myself and do light to normal activity (recurrent).

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?

Colorado Health FoundationLead Sponsor
2 Previous Clinical Trials
342 Total Patients Enrolled
Fred W. Hetzel, PhD, JDStudy ChairColorado Health Foundation

Media Library

Chemotherapy (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT00003788 — Phase 3
Brain Tumor Research Study Groups:
Brain Tumor Clinical Trial 2023: Chemotherapy Highlights & Side Effects. Trial Name: NCT00003788 — Phase 3
Chemotherapy (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00003788 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new patients currently being accepted into this clinical trial?

"According to the information available on clinicaltrials.gov, this study is not looking for new participants at this time. This particular trial was posted on April 1st, 1998 and last updated November 5th, 2013. There are other 116 trials that are currently searching for patients."

Answered by AI

Are there different research facilities working on this project?

"Currently, 4 different medical centres are enrolling patients for this clinical trial. These locations include Toronto, Englewood and Buffalo among others. If you are interested in participating, please select the location nearest to you to reduce travel burdens."

Answered by AI

Could you please list the risks associated with this treatment?

"The safety of this Phase 3 trial medication has been estimated to be a 3."

Answered by AI
~10 spots leftby Mar 2025