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New treatment option for Glioblastoma
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 infusion into 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 goal of this clinical trial is to evaluate how Acetadote affects metabolism in patients with glioblastoma. Drugs like Acetadote, which affect the level of damage in a cell (oxidative stress), may impact brain tumor metabolism and slow the growth of brain tumors.
- 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
- 5\. Adequate organ and marrow function as defined below:
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
- 5\. Adequate organ and marrow function as defined below:
- \- 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; abstinence) prior to study entry, for the duration of study participation...
- 6a. A female of child-bearing potential is any woman (regardless of sexual orientation, marital status, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- \- 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's taking place
- 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 - 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?
Study sites include Dallas, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.