Dose Escalation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma

PHASE1CompletedINTERVENTIONAL
Enrollment

17

Participants

Timeline

Start Date

June 15, 2016

Primary Completion Date

December 16, 2022

Study Completion Date

July 19, 2023

Conditions
Astrocytoma, Grade IVGiant Cell GlioblastomaGlioblastoma MultiformeGliosarcoma
Interventions
RADIATION

Radiation

Radiation therapy will be administered daily Monday-Friday at NCI, ROB unless the treatment schedule requires amendment in the event of inclement weather or federal holidays. Radiation therapy dose will be administered as per on consecutive treatment days, 5 fractions per week via a linear accelerator using 6 MV photons or greater. Dose escalation is as follows: dose level 1 (DL1) 3.5 Gy x 10; dose level 2 (DL2) 3.5 Gy x 12; dose level 3 (DL3) 3.5 Gy x 14. If 2 DLTs are observed in the second dose level a step down dose of 3.0 Gy x 14 fractions will be tested. If 2 DLTs are observed in the third dose level a step down dose of 3.0 Gy x 17 fractions will be tested. The study will have 3 planned re-irradiation dose levels, with 1 to 6 patients per dose level using the 3+3 design to define the MTD. The number of patients may be increased to 9 total patients at the MTD ( provided no DLT) with a maximum of 21 evaluable patients enrolled.

Trial Locations (1)

20892

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH

NCT02709226 - Dose Escalation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma | Biotech Hunter | Biotech Hunter