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Radiation and Temozolomide vs. PCV Chemotherapy for Brain Tumor

Phase 3

Waitlist Available

Research Sponsored by Alliance for Clinical Trials in Oncology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histological evidence of WHO grade III anaplastic glioma or WHO grade II low grade glioma with combined 1p/19q loss and IDH1 or IDH2 mutation

Mixed gliomas are eligible regardless of astrocytic or oligodendrocytic predominance if co-deleted for 1p and 19q

Must not have

Men or women of childbearing potential unwilling to use adequate contraception

Serious immunocompromised status (except related to concomitant steroids)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 16 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing whether giving radiation therapy with temozolomide drugs is more effective in treating brain tumors than giving radiation with another type of drug.

Who is the study for?

This trial is for patients with newly diagnosed anaplastic glioma or low grade glioma who have had surgery at least 2 weeks prior and are willing to provide tissue samples. They must not have received previous radiation or chemotherapy, be able to complete tests personally, and agree to use contraception. Excluded are those with severe diseases, recent hepatitis, pregnant/nursing women, history of other cancers within 5 years, heart issues within 6 months, HIV on retroviral therapy.

What is being tested?

The study compares two treatments: one combines radiation therapy with temozolomide (both during and after radiation), while the other uses radiation followed by PCV chemotherapy (vincristine, CCNU/lomustine, procarbazine). The goal is to determine which treatment is more effective in stopping tumor growth in brain tumors like anaplastic glioma or low grade glioma.

What are the potential side effects?

Possible side effects include fatigue from radiotherapy; nausea, vomiting, hair loss from temozolomide; and blood count changes from PCV chemo. Each drug can also cause unique reactions such as constipation or peripheral neuropathy from vincristine and lung problems from lomustine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My brain tumor is grade II or III with specific genetic changes.

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My brain tumor is a mixed glioma with specific genetic features (1p and 19q co-deletion).

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My low-grade brain tumor is considered high-risk.

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My tumor has an IDH mutation.

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My tumor has specific genetic changes, 1p/19q co-deletion and IDH mutation.

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My tumor has a specific genetic feature (loss of parts of chromosomes 1p and 19q).

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I am not pregnant or have confirmed it with a test.

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I had surgery over 2 weeks ago and have recovered well.

Exclusion Criteria

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

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I am of childbearing age and not willing to use birth control.

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I have a serious condition that weakens my immune system, not caused by steroids.

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I am HIV positive and currently on retroviral therapy.

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I have had radiation or chemotherapy for brain cancer before.

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I have had a heart attack in the last 6 months or need ongoing treatment for heart failure.

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I do not have severe illnesses that would prevent me from joining the study.

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I have not had another cancer besides this one in the last 5 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 16 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 16 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 16 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

Progression-free survival

Secondary study objectives

Objective tumor response defined as a complete response or partial response

Overall survival

Time to neurocognitive progression, assessed using the Hopkins Verbal Learning Test-Revised for Free Recall, Delayed Recall, and Delayed Recognition; the Controlled Oral Word Association test; and the Trail Making Test Part A or B

+2 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm B (RT, temozolomide)Experimental Treatment3 Interventions

Patients undergo RT as in arm I and receive temozolomide PO QD on days 1-5 for 5-7 weeks. Beginning 4 weeks after completion of concurrent chemoradiotherapy, patients receive adjuvant temozolomide PO QD days 1-5. Treatment with adjuvant temozolomide repeats every 4 weeks for 6-12 courses in the absence of disease progression and unacceptable toxicity.

Group II: Arm A (RT, procarbazine, lomustine, vincristine)Experimental Treatment4 Interventions

Patients undergo 3D-CRT or IMRT on days 1-5 for 5-7 weeks. Patients also receive procarbazine hydrochloride PO on days 8-21, lomustine PO on day 1 and vincristine sulfate IV on days 8 and 29 of courses 3-8. Treatment repeats every 6-7 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

radiotherapy

2007

Completed Phase 4

~3210

CCNU

2014

Completed Phase 3

~250