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

Glioblastoma Multiforme Clinical Trial

Official title: A Phase I Dose Escalation Trial of Re-Irradiation in Good Prognosis Recurrent Glioblastoma

Status Completed

Clinical Trial Summary

Background:

A glioblastoma is a tumor in the brain. It is treated with surgery, chemotherapy and radiation therapy. However, most people s tumors come back after therapy. When the tumor grows back, surgery or chemotherapy may not be possible or may no longer work. Repeat radiation therapy or re-irradiation, is an option for treating these tumors when they regrow.

Objective:

To find out the safety and highest tolerated dose of re-irradiation for people who have recurrent glioblastoma.

Eligibility:

People ages 18 50 who have glioblastoma that has been treated with radiation but has regrown.

Design:

Participants will be screened with:

Medical history

Physical exam

MRI of the brain: They will lie in a machine that takes pictures of the brain.

Participants will have baseline tests before they start therapy. These will include:

Blood tests

Neuropsychological tests: These test things like memory, attention, and thinking.

Quality of life questionnaire

Eye and hearing tests

Participants will get a CT of the brain prior to radiation start in order to plan the radiation treatment. Once the plan is completed, they will receive radiation once a day Monday Friday for a total of 10 17 treatments. They will lie on their back for about 10 minutes while they get the treatment.

Participants will be monitored for side effects.

After they finish treatment, participants will have visits 1, 2, and 3 months later. Then they will have them every 2 months for 3 years. These will include:

Medical history

Physical exam

Blood tests

MRI of the brain.

Quality of life questionnaire

Neuropsychological tests (at some visits)

After 3 years, participants will be contacted by phone each month.

Clinical Trial Description

Background

• Although the survival of gliomas has improved, most high grade gliomas will recur in field or adjacent to the treatment field within months to years of the original treatment. In newly diagnosed GBM, the concurrent use of radiation and temozolomide is standard of care.

• Surgical resection upon recurrence is possible in less than 50% of patients. For a significant proportion of recurrent glioma patients in whom reresection is not favourable and for whom systemic options have been exhausted, re-irradiation has emerged as a possible treatment option.

• Using modern precision RT techniques (stereotactic radiosurgery (SRS), stereotactic radiotherapy (SRT) or intensity modulated radiation therapy (IMRT), Rapid Arc techniques), re-irradiation has proven a feasible option with possible benefit in outcome as these techniques are often able to minimize dose to previously treated organs at risk in the field (OAR) and treat the recurrence safely.

• Data from multiple retrospective studies has indicated that not only is re-irradiation feasible, but it may actually improve survival in the appropriately selected patient.

Objective

The primary objective of this phase I study is to determine maximum tolerated re-irradiation dose (MTD).

Eligibility

• Recurrent glioblastoma or gliosarcoma

• Prior standard radiation therapy to a dose ranging from 50 to 60 Gy at 1.8 to 2 Gy per fraction.

• Prior irradiation > 12 months from enrollment on protocol.

• Age greater than or equal to 18.

• KPS greater than or equal to 70

Design

• Radiation therapy will be administered daily Monday-Friday at Radiation Oncology Branch (ROB), NCI. All the protocol related follow-up appointments will occur at NCI ROB. Radiation therapy dose will be administered on consecutive treatment days, 5 fractions per week via a linear accelerator using 6 MV photons or greater. Using a 3 plus 3 design , and three dose escalation levels, with 6 patients per dose level with 9 total patients at the MTD (provided no DLT), a maximum of 21 evaluable patients will be enrolled.

• Time to progression will be determined by the interval from initiation of treatment on protocol to progression as per RANO criteria.

• Neurologic decline without radiographic evidence of tumor will be designated as treatment related toxicity. Survival duration will be determined by the interval from initiation of treatment on protocol to date of death. ;

Related Conditions & MeSH terms

• Astrocytoma
• Astrocytoma, Grade IV
• Giant Cell Glioblastoma
• Glioblastoma
• Glioblastoma Multiforme
• Gliosarcoma

• NCT number: NCT02709226
• Study type: Interventional
• Source: National Institutes of Health Clinical Center (CC)
• Status: Completed
• Phase: Phase 1
• Start date: June 15, 2016
• Completion date: July 19, 2023