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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Stanford University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01977677
First received: October 31, 2013
Last updated: September 23, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention 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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Dose-limiting toxicity, defined as the absence of cardiac arrhythmia measured by electrocardiogram (ECG) or grade III or IV adverse events, using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 30 days post plerixafor ] [ Designated as safety issue: Yes ]
    Adverse events and qualifying dose limiting toxicity (DLT) will be tabulated by cohort, site and severity.


Secondary Outcome Measures:
  • Progression free survival based on the Response Assessment for Neuro-Oncology (RANO) criteria, using both clinical examinations and MRIs with and without contrast [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
    Summarized with Kaplan Meier estimates.


Estimated Enrollment: 29
Study Start Date: July 2014
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Names:
  • irradiation
  • radiotherapy
  • therapy, radiation
Drug: temozolomide
Given PO
Other Names:
  • SCH 52365
  • Temodal
  • Temodar
  • TMZ
Drug: plerixafor
Given IV
Other Names:
  • AMD 3100
  • Mozobil
Other: laboratory biomarker analysis
Correlative studies
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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])
  • Patient should have surgery (biopsy, partial resection or gross total resection) and no additional anti-cancer therapy
  • For those patients in which steroids are clinically indicated, there must be a stable dose of steroid medication for >= one week prior to the start of infusion
  • Patients must have Karnofsky performance score >= 60
  • Absolute neutrophil count (ANC) >= 1500
  • Platelets >= 100,000 ml
  • Serum creatinine =< 1.5 mg/dl
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 times the upper limit of normal
  • Serum potassium, magnesium and calcium within normal limits (supplementation to maintain normal electrolyte levels is acceptable)
  • 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01977677

Locations
United States, California
Stanford University Hospitals and Clinics Recruiting
Stanford, California, United States, 94305
Contact: Sophie Bertrand    650-723-4467    sophieb@stanford.edu   
Principal Investigator: Lawrence Recht         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Lawrence Recht Stanford University Hospitals and Clinics
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01977677     History of Changes
Other Study ID Numbers: BRN0023, NCI-2013-02012, BRN0023, P30CA124435
Study First Received: October 31, 2013
Last Updated: September 23, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Glioblastoma
Glioma
Gliosarcoma
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Medulloblastoma
Neoplasms
Astrocytoma
Neoplasms, Neuroepithelial
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Dacarbazine
JM 3100
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on October 19, 2014