Study on Using Ultrasound and a New Drug with Temozolomide for Treating Newly Diagnosed Glioblastoma
Sponsor: Alpheus Medical, Inc.
ClinicalTrials ID:NCT07225621
This clinical trial is testing a new treatment for glioblastoma, a type of brain cancer, using a combination of ultrasound and a new drug, alongside standard chemotherapy. The study aims to see if this approach can help treat the cancer more effectively.
Patient Parameters
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Program Overview
The purpose of this study is to test a new treatment for glioblastoma, a type of brain cancer, using a combination of a new drug (5-ALA) and a special ultrasound device. This treatment is given along with the standard chemotherapy drug, Temozolomide. Participants will be randomly assigned to receive either the active treatment or a placebo (inactive treatment) without knowing which one they are getting. The study aims to find out if this new approach can help control the cancer better after surgery and initial chemotherapy and radiation.
Eligibility Criteria
Inclusion Criteria
- Must be able to understand the study and agree to participate.
- Aged between 18 and 80 years.
- In good general health with a performance status of 2 or less.
- Newly diagnosed with glioblastoma, confirmed by specific medical tests.
- No progression of the disease after surgery and initial chemotherapy and radiation.
- Completed initial chemotherapy and radiation with at least 90% of the planned dose.
- Any side effects from previous treatment must be mild or resolved.
- Adequate blood cell counts and organ function based on specific lab tests.
- Women must not be pregnant or breastfeeding and must agree to use effective birth control.
- Men must agree to use effective birth control and not donate sperm during the study.
- No other cancer treatments during the study except for Temozolomide.
Exclusion Criteria
- Tumors located in certain areas of the brain.
- Multiple tumors or tumors affecting both sides of the brain.
- Certain types of brain disease or conditions.
- Use of high doses of steroids.
- Inability to undergo MRI scans.
- Allergies to the study drug or related substances.
- Certain physical characteristics that prevent the use of the study device.
- Recent strokes or brain bleeding not related to glioma surgery.
- Other cancers within the last 3 years, except for certain skin or cervical cancers.
- Significant brain swelling requiring urgent treatment.
- Rapidly worsening health condition.
- Previous treatments for glioma other than surgery and initial chemotherapy and radiation.
- Certain blood disorders or gastrointestinal issues.
- Active hepatitis B or C, or HIV infection.
- Participation in another clinical trial for glioblastoma.
- Use of certain medications that increase sensitivity to light.
- Other severe medical conditions that could affect participation.
- Women who are pregnant or breastfeeding.
- Any condition that might interfere with understanding the study or following instructions.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Dana Farber Cancer Institute | 02215 | Boston | Massachusetts |
| Albany Medical Center | 12208 | Albany | New York |
| Dent Neurologic Institute | 14226 | Buffalo | New York |
| Northwell Health | 11030 | Long Island City | New York |
| New York Langone | 10016 | New York | New York |
| Columbia University | 10032 | New York | New York |
| University of North Carolina | 27599 | Chapel Hill | North Carolina |
| Penn State Milton S. Hershey Medical Center | 17033 | Hershey | Pennsylvania |
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