Low Dose Radiation Therapy for Glioblastoma Multiforme

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byKristin Redmond, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Stay on Your Current Meds

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

To evaluate the safety and effectiveness of low dose rate radiation therapy plus temozolomide. This will be in patients with High Grade Glioma (to only include Anaplastic Astrocytoma or Glioblastoma Multiforme) who have previously been treated with surgery followed by radiation surgical resection followed by adjuvant radiation therapy plus temozolomide.

Eligibility Criteria

Inclusion Criteria

There must be measurable disease on MRI.

You have a diagnosis of glioblastoma multiforme or anaplastic astrocytoma.

You have previously undergone surgical resection (any extent okay) and adjuvant radiation therapy plus temozolomide.

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Treatment Details

Interventions

Low Dose Fractionated Radiation Therapy (LDFRT) (Radiation)
Temozolomide (Alkylating agents)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Temozolomide with Low Dose Fractionated Radiation TherapyExperimental Treatment2 Interventions

All patients will receive temozolomide (150 to 200 mg per square meter for 5 days during each 28 day cycle) for a total of 1 year or until the time of disease progression. All patients will receive 0.5 Gy of radiation therapy twice daily. This study will include a safety run-in component. If \> 33% of patients in the initial cohort of 6 experience grade 3 or greater hematologic toxicity according to the NCI Common Toxicity Criteria version 4, then a dose reduction will occur following the schedule listed below. Otherwise, following a 1 month waiting period after the first cycle of adjuvant LDFRT plus temozolomide for the first cohort of patients, the phase 2 study will open for full accrual. Patients will receive radiation with the first six 28-day cycles of temozolomide.