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Mycophenolate Mofetil + Radiation for Glioblastoma
Study Summary
This trial is testing a new cancer treatment that combines a drug called Mycophenolate Mofetil with radiation. The goal is to find the highest dose of the drug that can be given without causing serious side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- My cancer has spread to the lining of my brain and spinal cord.I have not had chemotherapy or radiation for my newly diagnosed glioblastoma or gliosarcoma.I can care for myself but may need occasional help.I have been diagnosed with HIV.I have not used bevacizumab in the last 8 weeks.I received radiation for a recurring condition within the last 6 months.I am eligible for another round of radiation for my brain tumor as per my doctor's advice.I have been diagnosed with glioblastoma or gliosarcoma.I had surgery within 4 weeks before starting radiation again.I am newly diagnosed with glioblastoma or gliosarcoma and can start treatment at least 14 days after my last surgery.My brain tumor affects three or more lobes.I have had an organ transplant.I have a deficiency in an enzyme called hypoxanthine-guanine phosphoribosyl-transferase.I have a condition that weakens my immune system.I am allergic to temozolomide or dacarbazine.My doctor recommends further surgery or biopsy for my brain tumor.I do not have an active infection in my body or brain.I have very low white blood cell counts and am on specific medication to prevent lung infections.I do not have any serious ongoing health issues.I am allergic to or cannot take mycophenolate mofetil or mycophenolic acid due to a doctor's advice.I have phenylketonuria.My biopsy tissue is needed for diagnosis and can't be used for research.I have not increased my steroid dose in the last 7 days.My tumor has not been diagnosed through tissue examination.
- Group 1: Phase 0 - Recurrent glioblastoma (GBM) / gliosarcoma (GS)
- Group 2: Phase 1 - Recurrent GBM / GS
- Group 3: Phase 1 - Newly Diagnosed GBM / GS
- 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
What other investigations have transpired regarding Radiation Therapy?
"At present, 129 separate studies are being conducted to research Radiation Therapy. Of those trials, 15 have progressed to Phase 3 and can be found in 841 locations worldwide; the majority of these clinical sites are situated in Philadelphia, Pennsylvania."
What medical maladies has Radiation Therapy been found to effectively treat?
"Radiation Therapy is an effective method of treating the rejection reaction after organ transplants, such as liver and heart transplantations, or renal grafts."
Is this experiment currently enrolling participants?
"Affirmative. Data from clinicaltrials.gov shows that this research endeavour, first posted on August 5th 2020, is actively recruiting participants. Sixty-eight individuals need to be enlisted across a single medical centre."
What risks should individuals be aware of when undergoing Radiation Therapy?
"There is limited clinical evidence supporting the safety of Radiation Therapy, thus it scored a 1 on our scale."
Can you explain the primary goals of this medical experiment?
"This clinical trial, lasting up to eleven weeks from the conclusion of MMF + RT + TMZ, intends to measure the number dose-limiting toxicities experienced by newly diagnosed phase 1 participants. Secondary objectives are determining median progression free survival in recurrent GBM/GS patients according to mRANO criteria, tabulating and categorizing any adverse events associated with treatment for new diagnosis phase 1 particpants, and measuring guanosine triphosphate (GTP) concentrations in plasma using mass spectrometry."
How many participants have taken part in this research?
"Affirmative. Evidence on clinicaltrials.gov indicates that this research endeavour, which was originally advertised on August 5th 2020, is accepting applications. Approximately 68 trialists are required to be recruited from a single facility."
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