Plerixafor After Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed High Grade Glioma

NCT ID: NCT01977677

Last Updated: 2018-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2018-09-30

Brief Summary

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.

Detailed Description

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.

Conditions

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)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

radiation therapy

Intervention Type: RADIATION

Undergo radiation therapy

temozolomide

Intervention Type: DRUG

Given PO

plerixafor

Intervention Type: DRUG

Given IV

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

pharmacological study

Intervention Type: OTHER

Correlative studies

Interventions

radiation therapy

Undergo radiation therapy

Intervention Type: RADIATION

temozolomide

Given PO

Intervention Type: DRUG

plerixafor

Given IV

Intervention Type: DRUG

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

pharmacological study

Correlative studies

Intervention Type: OTHER

Other Intervention Names

irradiation; radiotherapy; therapy, radiation; SCH 52365; Temodal; Temodar; TMZ; AMD 3100; Mozobil; pharmacological studies

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Lawrence Recht

OTHER

Sponsor Role: lead

Responsible Party

Lawrence Recht

Professor of Neurology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Lawrence Recht

Role: PRINCIPAL_INVESTIGATOR

Stanford University Hospitals and Clinics

Locations

Stanford University, School of Medicine

Stanford, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

NCI-2013-02012

Identifier Type: REGISTRY

Identifier Source: secondary_id

BRN0023

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA124435

Identifier Type: NIH

Identifier Source: secondary_id

View Link

BRN0023

Identifier Type: -

Identifier Source: org_study_id