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 : July 11, 2022
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|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. The primary purpose of this Phase II study is to evaluate the efficacy of Plerixafor administered with a modified radiation regimen that includes a component of WBRT. The primary endpoint is 6-month progression free survival post initiation of Chemoradiation.
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 :||January 2023|
|Estimated Study Completion Date :||July 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 post initiation of chemoradiation. 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Patients must have tissue confirmation of high grade (World Health Organization (WHO) grade IV) glioma including but not limited to glioblastoma, gliosarcoma, glioblastoma with oligodendroglial features, glioblastoma with primitive neuroectodermal tumor (PNET) features.
- The patient must have post-operative contrast enhanced imaging (computed tomography [CT] or magnetic resonance imaging [MRI]) unless only biopsy performed. For patients having biopsy alone, post-operative imaging is not routinely obtained and therefore the preoperative study will serve as baseline.
- Patient should have surgery (biopsy, partial resection or gross total resection) and no additional anti-cancer therapy except the chemo-radiation as specified in the protocol.
- Patients must have Karnofsky performance score >= 60.
- Absolute neutrophil count (ANC) >= 1500 (at time of screening).
- Platelets >= 100,000 ml (at time of screening).
- Serum creatinine =< 1.5mg/dl (at time of screening).
- Creatinine (Cr) clearance should be > 50 mL/min (at time of screening).
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 times the upper limit of normal (at time of screening).
- If female of childbearing potential, negative pregnancy test (at time of screening).
- The patient or his/her legal representative must have the ability to understand and willingness to sign a written informed consent document.
- Patient agrees to use an effective method of contraception (hormonal or two barrier methods) while on study and for at least 3 months following the plerixafor infusion.
- Prior or concurrent treatment with Avastin (bevacizumab).
- Prior exposure to plerixafor.
- Prior use of other investigational agents to treat the brain tumor.
- Recent history of myocardial infarct (less than 3 months) or history of active angina.
- Prior malignancy except for non-melanoma skin cancer and carcinoma in situ (of the cervix or bladder), unless diagnosed and definitively treated more than 3 years prior to 1st dose of investigational drug.
- Prior sensitivity to plerixafor.
- Pregnant or patients who are breastfeeding.
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): 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|
|Responsible Party:||Lawrence D Recht, Professor of Neurology, Stanford University|
|Other Study ID Numbers:||
NCI-2018-02159 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
BRN0037 ( Other Identifier: OnCore Number )
IRB-46410 ( Other Identifier: Stanford IRB )
|First Posted:||November 19, 2018 Key Record Dates|
|Last Update Posted:||July 11, 2022|
|Last Verified:||July 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|
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Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action