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

Primary Purpose

Adult Ependymoblastoma, Adult Giant Cell Glioblastoma, Adult Glioblastoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
radiation therapy
temozolomide
plerixafor
laboratory biomarker analysis
pharmacological study
Sponsored by
Lawrence Recht
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adult Ependymoblastoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University, School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (radiation therapy, temozolomide, plerixafor)

Arm Description

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.

Outcomes

Primary Outcome Measures

Dose-limiting Toxicity
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
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.

Secondary Outcome Measures

Full Information

First Posted
October 31, 2013
Last Updated
September 27, 2018
Sponsor
Lawrence Recht
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01977677
Brief Title
Plerixafor After Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed High Grade Glioma
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 Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lawrence Recht
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (radiation therapy, temozolomide, plerixafor)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Other Intervention Name(s)
irradiation, radiotherapy, therapy, radiation
Intervention Description
Undergo radiation therapy
Intervention Type
Drug
Intervention Name(s)
temozolomide
Other Intervention Name(s)
SCH 52365, Temodal, Temodar, TMZ
Intervention Description
Given PO
Intervention Type
Drug
Intervention Name(s)
plerixafor
Other Intervention Name(s)
AMD 3100, Mozobil
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
pharmacological study
Other Intervention Name(s)
pharmacological studies
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Dose-limiting Toxicity
Description
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)
Time Frame
Up to 30 days post plerixafor
Title
Participants Alive and Without Disease Progression At 6 Months After the Start of the Irradiation
Description
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.
Time Frame
6 months from start of irradiation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence Recht
Organizational Affiliation
Stanford University Hospitals and Clinics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University, School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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