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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

Must not have

Patients with gliomatosis cerebri type 1 or 2

Female patients who are pregnant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5.5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with gliomatosis cerebri type 1 or 2.

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I am currently pregnant.

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I have been diagnosed with oligodendroglioma.

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I have been diagnosed with pleomorphic xanthoastrocytoma.

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My primary cancer is in the brainstem or spinal cord.

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I have AML or MDS possibly caused by previous treatments.

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I have received treatment specifically for my tumor.

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I cannot undergo the specific radiation therapy outlined in the study.

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My cancer has spread to my nervous system.

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I have a genetic condition known as CMMR-D or bMMRD.

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I have had a bone marrow or double cord blood transplant.

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I have been diagnosed with a grade 2 diffuse astrocytoma.

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I am a woman who could become pregnant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5.5 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Event Free Survival (EFS)

Secondary study objectives

Objective Response

Overall Survival (OS)

Other study objectives

Biomarker Analysis

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~1880