Glioblastoma study: Acetadote
Official title Imaging Acetadote Metabolism in Glioblastoma
ClinicalTrials.gov ID: NCT07387666
What this study is testing
What is Acetadote?
Acetadote is an investigational medicine, given as an IV infusion (through a vein), being studied as a potential treatment for glioblastoma.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether Acetadote changes brain tumor metabolism in people with newly diagnosed glioblastoma.
- Who it's for
- You may be able to join if you have a new diagnosis of glioblastoma and are planning surgery.
- What's involved
- You would receive Acetadote before your tumor is removed. You will have MRI scans and the removed tissue will be studied.
- Time commitment
- The study lasts around the time of your surgery with a few visits for scans and follow‑up.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 1\. Glioblastoma
- 2\. Newly diagnosed with no prior surgery, radiation, chemotherapy, or other tumor-treating agent
- 3\. Age ≥18 years
- 4\. KPS \> 70
- \- Bilirubin ≤1.5 times upper limit of normal
You likely can't join if
- 1.Chemotherapy, radiotherapy, or other cancer therapy within 4 weeks prior to starting study treatment.
- 2\. people must have recovered from prior treatment-related toxicities to grade 2 or baseline (excluding alopecia and clinically stable toxicities...
- 3\. people may not be receiving any other investigational agents for the treatment of the cancer under study.
- 4\. Brain metastases
- 5\. History of allergic or hypersensitivity reactions attributed to compounds of similar chemical or biologic composition to Acetadote.
- 6\. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable...
See the full eligibility criteria
- 1\. Glioblastoma
- 2\. Newly diagnosed with no prior surgery, radiation, chemotherapy, or other tumor-treating agent
- 3\. Age ≥18 years
- 4\. KPS \> 70
- \- Bilirubin ≤1.5 times upper limit of normal
- \- AST and ALT ≤ 3 times ULN
- \- Creatinine ≤ 1.5 x ULN and/or GFR ≤ 60 mL/min
- -ANC ≥ 1000 cells/ul
- \- Platelet ≥ 100,000/ul
- \- Hemoglobin ≥ 9 g/dl
- 6\. All men, as well as women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control
- \- Has not undergone a hysterectomy or bilateral oophorectomy; or
- \- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
- 7\. Ability to understand and the willingness to sign a written informed consent.
- 1.Chemotherapy, radiotherapy, or other cancer therapy within 4 weeks prior to starting study treatment.
- 2\. people must have recovered from prior treatment-related toxicities to grade 2 or baseline (excluding alopecia and clinically stable toxicities requiring ongoing medical management, such as hypothyroidism from prior...
- 3\. people may not be receiving any other investigational agents for the treatment of the cancer under study.
- 4\. Brain metastases
- 5\. History of allergic or hypersensitivity reactions attributed to compounds of similar chemical or biologic composition to Acetadote.
- 6\. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social...
- 7\. people must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
The study team makes the final eligibility decision.
Where it is enrolling
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Dallas, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.