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RRx-001 + Chemotherapy for Brain Cancer (PIRATE Trial)
PIRATE Trial Summary
This trial is testing the experimental drug RRx-001 in combination with 2 chemotherapy drugs that are commonly used in cancer patients. RRx-001 has been used before in adults, but the investigators don't know what effects it will have in children and young adults.
PIRATE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPIRATE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.PIRATE Trial Design
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Who is running the clinical trial?
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- My neurological symptoms have been stable for at least a week.I have recovered from side effects of my last cancer treatment.My platelet count is above 75,000 and I haven't needed a transfusion in the last week.My kidney function is normal or only mildly reduced.I have good lung function, no shortness of breath at rest, and a healthy heart.Your AST level in the blood is not more than three times the normal limit.I (or my guardian) understand the consent form and agree to sign it.Your ALT level in the blood is not more than three times the normal limit at the study site's lab.I haven't taken strong CYP3A4 inducers in the last 14 days.I had major surgery or a biopsy at least 4 weeks or 1 week ago, respectively.I do not have major heart, lung, liver, or other organ problems that would make the treatment risky for me.I do not have heart disease, blood disorders, active infections, another cancer, blood clotting disorders, or a history of blood clots.I have been on a stable or decreasing dose of steroids for at least a week.I will use birth control during and for 28 days after the study.I can safely swallow pills or liquid medicine.I have a bleeding disorder or have had an organ or bone marrow transplant.You have a sufficient number of a type of white blood cell called neutrophils in your blood.I am not on any other cancer or experimental drugs.My cancer is a high-grade tumor in the brain or spinal cord, not lymphoma.I am not taking supplements like vitamin E or omega 3.I am not taking clozapine, echinacea, leflunomide, natalizumab, or tofacitinib.My cancer can be measured or evaluated by specific guidelines.I am mostly capable of self-care and daily activities.Your bilirubin levels are not too high.
- Group 1: RRx-001, Temozolomide and Irinotecan
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Do participants need to be younger than 30 years old in order to qualify for this experiment?
"The minimum age to partake in this research is 1 year and the maximum allowed enrollment age is 21."
What prior research has been conducted regarding the effects of RRx-001?
"Currently, 439 clinical trials are actively studying RRx-001 with 75 of those in their final stage. Although the majority are situated in Adelaide, South Australia, there exists a total of 12804 sites researching this medication."
Are there any enrollment opportunities available for this trial currently?
"According to clinicaltrials.gov, this trial is still in the recruitment process. It was published on December 1st 2022 and recently modified on August 15th 2022."
Has RRx-001 been granted regulatory clearance by the FDA?
"Since RRx-001 is in a Phase 1 trial, there is restricted evidence on its safety and effectiveness. Therefore, our team at Power scored it an overall 1 out of 3."
Who can partake in this medical investigation?
"This trial is recruiting a maximum of 24 participants between the ages 1 and 21 with central nervous system neoplasms. To be eligible, all patients must meet these prerequisites: stable neurological deficits for no less than 7 days prior to enrollment; seizure frequency/duration maintained at baseline levels for at least the same amount of time; chronic systemic steroid use stabilized or decreasing within 14 days before application; Karnofsky score ≥50% (if >16) or Lansky score ≥50 (if ≤16); treatment-related toxicities <grade 1 level; 4 weeks since major surgery including craniotomy + one week since stereotactic bi"
How many participants can take part in this trial before it is full?
"Indeed, the data found on clinicaltrials.gov affirms that recruitment for this medical research is still open. It was first posted in December 1st 2022 and last edited on August 15th of the same year. This trial seeks to enroll 24 patients from a single site."
What indications has RRx-001 been used to address?
"RRx-001 is frequently deployed in the treatment of melanoma, and can also be helpful for individuals with soft tissue sarcoma (STS), primary central nervous system lymphoma (PCNSL) and other malignancies."
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