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Veliparib + Radiation + Temozolomide for Brain Cancer
Study Summary
This trial is studying a combination of drugs as a potential treatment for newly diagnosed malignant glioma. The drugs being studied are veliparib, radiation therapy, and temozolomide.
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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- My kidney function, measured by creatinine clearance or GFR, is normal or above.I am between 3 and 21 years old.My bilirubin levels are within the normal range for my age.I have been diagnosed with gliomatosis cerebri type 1 or 2.I am currently pregnant.I am sexually active and capable of having children.I am between 3 and 21 years old.My test for H3 K27M mutation is negative.I have been diagnosed with oligodendroglioma.I can take care of myself but may not be able to do heavy physical work.My hemoglobin level is at least 8.0 gm/dL, transfusions are okay.My treatment is scheduled to start within 31 days after my surgery.I must get brain MRIs before and after surgery unless I only have a biopsy. A positive spine MRI means I can't join.I have been diagnosed with pleomorphic xanthoastrocytoma.My primary cancer is in the brainstem or spinal cord.I have AML or MDS possibly caused by previous treatments.I have received treatment specifically for my tumor.I cannot undergo the specific radiation therapy outlined in the study.I am between 3 and 25 years old with an IDH mutant condition.I have been recently diagnosed with a high-grade brain tumor.My cancer has spread to my nervous system.I have a genetic condition known as CMMR-D or bMMRD.I have had a bone marrow or double cord blood transplant.I have been diagnosed with a grade 2 diffuse astrocytoma.I am a woman who could become pregnant.My cancer diagnosis is confirmed by tissue examination, and it has not spread to my nervous system.My cancer does not have the BRAFV600 mutation.
- Group 1: Treatment (radiation therapy, veliparib, temozolomide)
- 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
How extensive is the recruitment process for this experiment?
"No longer recruiting, this trial was originally posted on October 31st 2018 and saw its last update in mid-October 2022. For those searching for other clinical trials, there are currently 714 studies actively seeking patients with glioblastoma and 225 open to enrolling Veliparib participants."
Are there a variety of locations within Canada that are administering this medical experiment?
"Patients can join this medical trial at multiple sites, including the Centre Hospitalier Universitaire Sainte-Justine in Montreal, Quebec; Geisinger Medical Center in Danville, Pennsylvania; and Legacy Emanuel Children's Hospital in Portland, Oregon."
What are the principal applications of Veliparib?
"A common use of veliparib is as part of nitrosourea treatment. Additionally, it can be utilized for select cases involving mycosis fungoides and refractory neuroblastoma, along with other advanced directives."
Is there an opportunity for me to become involved in this investigation?
"Patients aged 3 to 25 with a diagnosis of glioblastoma have the opportunity to join this clinical trial, which is recruiting 115 participants in total."
Is this an innovative trial?
"Presently, there are 225 clinical investigations related to Veliparib being conducted across 1114 cities in 36 different nations. The inaugural trial of this drug was sponsored by Schering-Plough and began running back in 2002; the Phase 2 approval stage for this 60 person study was finished a number of years ago. Subsequently, 438 such trials have been completed up until now."
Is Veliparib an effective and safe intervention for those receiving care?
"Although there is some preliminary evidence of Veliparib's safety, efficacy has yet to be demonstrated. Thus, it was deemed a 2 on our 1-3 scale."
Has research utilizing Veliparib been previously documented?
"Veliparib was initially studied in 2002 at Memorial Sloan Kettering Cancer Center, and since then 438 clinical trials have been completed. In the present day, there are 225 actively recruiting studies with a considerable number of these trials taking place within Montreal, Quebec."
Does this experiment have any remaining slots for participants?
"This clinical trial has concluded its recruitment process. It was initially posted on October 31st 2018 and last updated on October 18th 2022. For those looking for alternative studies, there are currently 714 glioblastoma-focused trials recruiting participants as well as 225 Veliparib related investigations seeking volunteers."
Does this research permit elderly participants?
"This clinical trial has a strict age range limitation that only admits people aged between 3 and 25. An additional 192 studies are available for minors, while 779 trials are open to seniors beyond the retirement threshold."
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