Whole Brain Radiation Therapy With Standard Temozolomide Chemo-Radiotherapy and Plerixafor in Treating Patients With Glioblastoma
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|ClinicalTrials.gov Identifier: NCT03746080|
Recruitment Status : Recruiting
First Posted : November 19, 2018
Last Update Posted : December 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Glioblastoma With Primitive Neuronal Component Gliosarcoma Malignant Glioma Oligodendroglial Component Present||Drug: Plerixafor Drug: Temozolomide Radiation: Whole-Brain Radiotherapy (WBRT) Radiation: Radiation Therapy||Phase 2|
I. To assess the 6 month progression-free survival (PFS) (post initiation of radiation) of continuous infusion plerixafor beginning one week prior to the end of concurrent chemotherapy with temozolomide and a modified radiation regimen that includes a component of whole brain radiation therapy (WBRT) in patients with newly diagnosed glioblastoma (GBM).
I. To assess the median survival of patients treated with continuous infusion plerixafor/WBRT.
II. To assess the toxicities both short and long term of continuous infusion plerixafor/WBRT.
III. To assess the patterns of failure (in and out of irradiated brain field, out of brain) of continuous infusion plerixafor/WBRT.
After completion maximal safe surgical resection, patients undergo radiation therapy for 42 days, initiating whole brain radiation therapy at day 21 (dose 16 of radiation therapy) and receive temozolomide daily on days 1-42. Beginning 7 days before the completion of whole brain radiation therapy, patients receive plerixafor by continuous infusion on days 1-28. Beginning 1 week after completion of plerixafor infusion and 35 days after completion of whole brain radiation therapy, patients receive temozolomide monthly for 6-12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for adverse events for 30 days after the last dose of Plerixafor and then every 12 weeks for 5 years for survival follow-up.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Follow-Up Study to Add Whole Brain Radiotherapy (WBRT) to Standard Temozolomide Chemo-Radiotherapy in Newly Diagnosed Glioblastoma (GBM) Treated With 4 Weeks of Continuous Infusion Plerixafor|
|Actual Study Start Date :||December 4, 2018|
|Estimated Primary Completion Date :||July 11, 2022|
|Estimated Study Completion Date :||January 11, 2027|
Experimental: Whole Brain Radiotherapy + Plerixafor +Chemoradiotherapy
After completion maximal safe surgical resection, patients undergo radiation therapy for 42 days, initiating whole brain radiation therapy at day 21 (dose 16 of radiation therapy) and receive temozolomide daily on days 1 to 42. Beginning 7 days before the completion of whole brain radiation therapy, patients receive plerixafor by continuous infusion on days to 1 to 28. Beginning 1 week after completion of plerixafor infusion and 35 days after completion of whole brain radiation therapy, patients receive temozolomide monthly for 6 to 12 courses in the absence of disease progression or unacceptable toxicity.
Plerixafor will be administered via infusion at 400 micrograms per kilogram per day for four weeks beginning one week before the end of radiation
Temozolomide (TMZ) will be administered concurrently with the radiation for 42 days and 6-12 cycles of monthly adjuvant Temozolomide (TMZ) after completion of Plerixafor infusion.
Radiation: Whole-Brain Radiotherapy (WBRT)
Undergo Whole brain radiotherapy (WBRT) - Radiotherapy consists of 30 Gy in 15 fractions of whole brain radiations
Radiation: Radiation Therapy
Radiotherapy consists of 30 Gy in 15 fractions
- Progression-free survival (PFS) at six months [ Time Frame: 6 months ]Progression free survival will be measured at 6 months from diagnosis by biopsy or surgical resection. Simon 2-stage design will be use to assess progression-free survival. Will be computed from start of induction therapy and summarized with Kaplan-Meier estimates.
- Median Survival [ Time Frame: 32 months ]Median survival will be assessed at 32 months of subjects who have completed the 28 day Plerixafor infusion. Will be computed from start of induction therapy and summarized with Kaplan-Meier estimates.
- Toxicity associated with Plerixafor/WBRT [ Time Frame: 30 days ]Incidence of adverse events will be graded and recorded per Common Terminology Criteria for Adverse Events version 5.0. Will assess reported toxicities up until 30 days of treatment. Adverse events and qualifying dose limiting toxicities (DLTs) will be tabulated by cohort, site and severity.
- Patterns of treatment failure [ Time Frame: 5 years ]Will assess pattern of failure (out-of-field occurrence or occurrence outside of the brain) over time. Local treatment failure is defined as within the 95% isodose region
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03746080
|Contact: Hari Priya Yerraballafirstname.lastname@example.org|
|Contact: Sophie Bertrandemail@example.com|
|United States, California|
|Stanford Cancer Institute Palo Alto||Recruiting|
|Palo Alto, California, United States, 94304|
|Contact: Lawrence Recht 650-725-8630 firstname.lastname@example.org|
|Principal Investigator: Lawrence Recht|
|Principal Investigator:||Lawrence Recht||Stanford Cancer Institute Palo Alto|