Combination Therapy for Glioblastoma

Recruiting in Palo Alto (17 mi)

Overseen byWenyin Shi, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

No Placebo Group

Trial Summary

What is the purpose of this trial?

This pilot early phase I trial studies the side effects of temozolomide, radiation therapy, and tumor treating fields therapy using Novo tumor treatment fields (TTF)-200A device in participants with glioblastoma. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. NovoTTF-200A device is a portable device that produces alternating electrical fields that may disrupt growth of cancer cells. Giving temozolomide, radiation therapy, and tumor treating fields therapy using NovoTTF-200A device may work better in treating participants with glioblastoma.

Research Team

Wenyin Shi, MD

Principal Investigator

Sidney Kimmel Cancer Center at Thomas Jefferson University

Eligibility Criteria

This trial is for adults with newly diagnosed grade IV glioblastoma. Participants must have adequate blood counts, kidney and liver function, and be at least 21 days post-surgery or 14 days post-biopsy. Women who can bear children need a negative pregnancy test before joining.

Inclusion Criteria

You have been diagnosed with a specific type of aggressive brain tumor called WHO grade IV glioma.

Your hemoglobin level is 9.0 grams per deciliter or higher.

You had surgery, and your doctor thinks you've healed enough. It has been at least 21 days since your surgery before starting the treatment in the study. If you had a core or needle biopsy, it has been at least 14 days before starting the treatment in the study.

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Treatment Details

Interventions

NovoTTF-200A Device (Device)
Radiation Therapy (Radiation)
Temozolomide (Alkylating agents)

Trial OverviewThe study tests the combination of Temozolomide (chemotherapy), Radiation Therapy, and NovoTTF-200A Device (a device that disrupts cancer cell growth) to see if they work better together in treating glioblastoma.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (temozolomide, radiation, NovoTTF-200A device)Experimental Treatment4 Interventions

Participants receive temozolomide PO QD starting day 1 to the end of radiation therapy and undergo 30 fractions of radiation therapy over 15-20 minutes each, 5 days a week (Monday-Friday) for 6 weeks. Beginning day 1 of radiation therapy, participants undergo tumor treatment fields therapy using NovoTTF-200A device over 18 hours or more daily in the absence of disease progression or unacceptable toxicity. Beginning 28 days after the last dose of radiation therapy, participants receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

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