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

NCT01977677 | Completed Phase 1 Results DMC

• 3 other identifiers: BRN0023NCI-2013-02012P30CA124435
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

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)

Outcome Measures

Primary Outcomes (2)

• 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)

  Up to 30 days post plerixafor

• 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.

  6 months from start of irradiation

Study Arms (1)

Treatment (radiation therapy, temozolomide, plerixafor)

EXPERIMENTAL

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; Drug: temozolomide; Drug: plerixafor; Other: laboratory biomarker analysis; Other: pharmacological study

Interventions

radiation therapy RADIATION

Undergo radiation therapy

Also known as: irradiation, radiotherapy, therapy, radiation

Treatment (radiation therapy, temozolomide, plerixafor)

temozolomide DRUG

Given PO

Also known as: SCH 52365, Temodal, Temodar, TMZ

Treatment (radiation therapy, temozolomide, plerixafor)

plerixafor DRUG

Given IV

Also known as: AMD 3100, Mozobil

Treatment (radiation therapy, temozolomide, plerixafor)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (radiation therapy, temozolomide, plerixafor)

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Treatment (radiation therapy, temozolomide, plerixafor)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lawrence Recht: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Stanford University, School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Neuroectodermal Tumors, Primitive; Glioblastoma; Gliosarcoma; Medulloblastoma; Glioma; Pinealoma

Interventions

Radiotherapy; Radiation; Temozolomide; plerixafor

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Astrocytoma; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Physical Phenomena; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Lawrence Recht, MD, Professor of Neurology
• Organization: Stanford University School of Medicine

lrecht@stanford.edu

650-725-8630

Study Officials

• Lawrence Recht

  Stanford University Hospitals and Clinics

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: October 31, 2013
• First Posted: November 7, 2013
• Study Start: November 1, 2014
• Primary Completion: November 1, 2017
• Study Completion: September 1, 2018
• Last Updated: October 23, 2018
• Results First Posted: July 3, 2018

Record last verified: 2018-09

Locations

US (1)