Plerixafor After Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed High Grade Glioma
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|ClinicalTrials.gov Identifier: NCT01977677|
Recruitment Status : Completed
First Posted : November 7, 2013
Results First Posted : July 3, 2018
Last Update Posted : October 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Adult Ependymoblastoma Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma Adult Medulloblastoma Adult Mixed Glioma Adult Oligodendroglial Tumors Adult Pineoblastoma Adult Supratentorial Primitive Neuroectodermal Tumor (PNET)||Radiation: radiation therapy Drug: temozolomide Drug: plerixafor Other: laboratory biomarker analysis Other: pharmacological study||Phase 1 Phase 2|
I. To assess the safety of using continuous infusion Plerixafor subsequent to irradiation in patients with newly diagnosed glioblastoma multiforme (GBM).
II. To assess the efficacy of Plerixafor as measured by progression free survival at 6 months (PFS6) from the start of irradiation.
OUTLINE: This is a phase I, dose-escalation study of plerixafor followed by a phase II study.
Within 4 weeks of surgery, patients undergo radiation therapy and receive temozolomide orally (PO) over 42 days. Beginning 8 days prior to completion of chemoradiotherapy, patients receive plerixafor intravenously (IV) continuously for 2-4 weeks. Patients also receive temozolomide PO 5 days a month beginning 35 days after completion of radiation therapy.
After completion of study treatment, patients are followed up every 12 weeks for 5 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Study of Local Field Irradiation and Temozolomide Followed by Continuous Infusion Plerixafor as an Upfront Therapy for Newly Diagnosed Glioblastoma GBM|
|Study Start Date :||November 2014|
|Actual Primary Completion Date :||November 2017|
|Actual Study Completion Date :||September 2018|
Experimental: Treatment (radiation therapy, temozolomide, plerixafor)
Within 4 weeks of surgery, patients undergo radiation therapy and receive temozolomide PO over 42 days. Beginning 8 days prior to completion of chemoradiotherapy, patients receive plerixafor IV continuously for 2-4 weeks. Patients also receive temozolomide PO 5 days a month beginning 35 days after completion of radiation therapy.
Radiation: radiation therapy
Undergo radiation therapy
Other: laboratory biomarker analysis
Other: pharmacological study
Other Name: pharmacological studies
- Dose-limiting Toxicity [ Time Frame: Up to 30 days post plerixafor ]Dose Limiting Toxicity is defined as defined as any hematologic or on-hematologic adverse events grade 3 or higher using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 with a suspected causal relationship to Plerixafor (including electrocardiogram changes indicative of ischemia, ventricular tachycardia)
- Participants Alive and Without Disease Progression At 6 Months After the Start of the Irradiation [ Time Frame: 6 months from start of irradiation ]Progression free survival based on the Response Assessment for Neuro-Oncology (RANO) criteria, using both clinical examinations and MRIs with and without contrast summarized with Kaplan Meier estimates.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01977677
|United States, California|
|Stanford University, School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Lawrence Recht||Stanford University Hospitals and Clinics|