Plerixafor After Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed High Grade Glioma
| Status: | Completed |
|---|---|
| Conditions: | Brain Cancer, Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 10/25/2018 |
| Start Date: | November 2014 |
| End Date: | September 2018 |
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
This pilot phase I/II trial studies the side effects and best dose of plerixafor after
radiation therapy and temozolomide and to see how well it works in treating patients with
newly diagnosed high grade glioma. Plerixafor may stop the growth of tumor cells by blocking
blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, work in different
ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Radiation therapy uses high energy x rays to kill tumor cells. Giving plerixafor
after radiation therapy and temozolomide may be an effective treatment for high grade glioma.
radiation therapy and temozolomide and to see how well it works in treating patients with
newly diagnosed high grade glioma. Plerixafor may stop the growth of tumor cells by blocking
blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, work in different
ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Radiation therapy uses high energy x rays to kill tumor cells. Giving plerixafor
after radiation therapy and temozolomide may be an effective treatment for high grade glioma.
PRIMARY OBJECTIVES:
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.
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.
Inclusion Criteria:
- Patients must have tissue confirmation of high grade (WHO Grade IV) glioma including
but not limited to glioblastoma, gliosarcoma, glioblastoma with oligodendroglial
features, glioblastoma with PNET features.
- The patient must have post-operative contrast enhanced imaging (CT or MRI) unless only
biopsy performed (in which case post-operative imaging is not routinely obtained. In
these patients, 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 chemoradiation as specified in the
protocol.
- For those patients in which steroids are clinically indicated, there must be a stable
or decreasing dose of steroid medication for ≥ one week prior to the start of
infusion.
- Patients must be between the ages of 18 and 75 years old.
- Patients must have Karnofsky Performance score ≥ 60.
- Adequate organ function is needed at time of screening visit including:
- ANC ≥ 1500
- Platelets ≥ 100,000 ml
- Serum Creatinine ≤ 1.5mg/dl; Cr Clearance should be >50 mL/min
- AST and ALT ≤ 3 times the upper limit of normal
- If female of childbearing potential, negative pregnancy test
- 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
Exclusion Criteria:
- 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
or arrhythmia
- Prior malignancy except previously diagnosed and definitively treated more than 3
years prior to trial or whose prognosis is deemed good enough to not warrant
surveillance
- Prior sensitivity to Plerixafor
- Pregnant or patients who are breastfeeding
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