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Veliparib + Radiation + Temozolomide for Brain Cancer

Phase 2
Waitlist Available
Led By Matthias A Karajannis
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2
Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5.5 years
Awards & highlights

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.

Who is the study for?
This trial is for patients with newly diagnosed malignant glioma without certain mutations (H3 K27M or BRAFV600). Eligible participants are between 3-25 years old, have not received prior tumor-directed therapy, and can start treatment within 31 days after surgery. They must have proper organ function and controlled seizures if present.Check my eligibility
What is being tested?
The study tests the effectiveness of veliparib combined with radiation therapy and temozolomide in treating malignant glioma. Veliparib is a PARP inhibitor that may prevent tumor cells from repairing DNA damage, potentially enhancing the effects of chemotherapy and radiation.See study design
What are the potential side effects?
Potential side effects include nausea, fatigue, low blood counts leading to increased infection risk or bleeding problems, liver issues indicated by altered blood tests, kidney function changes requiring monitoring through blood tests, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function, measured by creatinine clearance or GFR, is normal or above.
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My bilirubin levels are within the normal range for my age.
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I am between 3 and 21 years old.
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I can take care of myself but may not be able to do heavy physical work.
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My hemoglobin level is at least 8.0 gm/dL, transfusions are okay.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Event free survival (EFS)
Secondary outcome measures
Objective response
Overall survival (OS)
Other outcome measures
Biomarker analysis

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (radiation therapy, veliparib, temozolomide)Experimental Treatment3 Interventions
CHEMORADIOTHERAPY PHASE: Patients receive veliparib PO BID and undergo 30 daily fractions of radiation therapy 5 days per week for 6-7 weeks in the absence of disease progression or unacceptable toxicity. MAINTENANCE CHEMOTHERAPY: Beginning 4 weeks after chemoradiotherapy phase, patients receive veliparib PO BID and temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 10 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Veliparib
2012
Completed Phase 3
~4820
Temozolomide
2010
Completed Phase 3
~1930
Radiation Therapy
2017
Completed Phase 3
~7250

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,633 Previous Clinical Trials
40,928,710 Total Patients Enrolled
316 Trials studying Glioblastoma
22,630 Patients Enrolled for Glioblastoma
Matthias A KarajannisPrincipal InvestigatorChildren's Oncology Group

Media Library

Radiation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT03581292 — Phase 2
Glioblastoma Research Study Groups: Treatment (radiation therapy, veliparib, temozolomide)
Glioblastoma Clinical Trial 2023: Radiation Therapy Highlights & Side Effects. Trial Name: NCT03581292 — Phase 2
Radiation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT03581292 — Phase 2
Glioblastoma Patient Testimony for trial: Trial Name: NCT03581292 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
California
How old are they?
18 - 65
65+
What site did they apply to?
Mattel Children's Hospital UCLA
Carolinas Medical Center/Levine Cancer Institute
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

Why did patients apply to this trial?

Because I’m covering all my options!
PatientReceived 1 prior treatment
~6 spots leftby Apr 2025