Radiation and Temozolomide vs. PCV Chemotherapy for Brain Tumor

Recruiting in Palo Alto (17 mi)

+304 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Alliance for Clinical Trials in Oncology

Stay on Your Current Meds

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving radiation with concomitant and adjuvant temozolomide versus radiation with adjuvant PCV is more effective in treating anaplastic glioma or low grade glioma.

Research Team

Kurt Jaeckle, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.

Inclusion Criteria

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

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

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

Exclusion Criteria

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

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

I am HIV positive and currently on retroviral therapy.

Treatment Details

Interventions

• CCNU (Alkylating agents)
• Radiotherapy (Radiation)
• Temozolomide (Alkylating agents)

Trial Overview 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.

Participant Groups

Group I: Arm B (RT, temozolomide) Experimental Treatment 3 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 Treatment 4 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.

Radiotherapy is already approved in Canada, Japan, China, Switzerland for the following indications:

Approved in Canada as Radiation therapy for:

• Various cancers including breast cancer, lung cancer, prostate cancer, and soft tissue sarcoma

Approved in Japan as Radiation therapy for:

• Various cancers including breast cancer, lung cancer, prostate cancer, and soft tissue sarcoma

Approved in China as Radiation therapy for:

• Various cancers including breast cancer, lung cancer, prostate cancer, and soft tissue sarcoma

Approved in Switzerland as Radiation therapy for:

• Various cancers including breast cancer, lung cancer, prostate cancer, and soft tissue sarcoma

Who Is Running the Clinical Trial?

Alliance for Clinical Trials in Oncology

Lead Sponsor

Trials

521

Recruited

224,000+

Suzanne George

Alliance for Clinical Trials in Oncology

Chief Medical Officer since 2015

MD from Harvard Medical School

Evanthia Galanis

Alliance for Clinical Trials in Oncology

Chief Executive Officer since 2022

MD from Mayo Clinic

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Canadian Cancer Trials Group

Collaborator

Trials

135

Recruited

70,300+

Dr. Janet Dancey

Canadian Cancer Trials Group

Chief Medical Officer since 2014

MD, FRCPC

Susan Marlin

Canadian Cancer Trials Group

Chief Executive Officer since 2012

BSc (Hons) from Dalhousie University, MSc in Community Health and Epidemiology from Queen’s University

European Organisation for Research and Treatment Center (EORTC)

Collaborator

Trials

1

Recruited

310+