Clinical trial NCT00430079: Use of EF5 to Measure the Oxygen Level in Tumor Cells of Patients Undergoing Surgery or Biopsy for Newly Diagnosed Supratentorial Malignant Glioma
Official title: Assessment of Hypoxia in Malignant Gliomas Using EF5
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Adult Anaplastic Astrocytoma
Adult Anaplastic Ependymoma
Adult Anaplastic Oligodendroglioma
Adult Diffuse Astrocytoma
Adult Ependymoma
Adult Giant Cell Glioblastoma
Adult Glioblastoma
Adult Gliosarcoma
Adult Mixed Glioma
Adult Myxopapillary Ependymoma
Adult Oligodendroglioma
Adult Pilocytic Astrocytoma
Adult Pineal Gland Astrocytoma
Adult Subependymoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2007-02-01
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This clinical trial is using EF5 to measure the oxygen level in tumor cells of patients undergoing surgery or surgery biopsy for newly diagnosed supratentorial malignant glioma. Diagnostic procedures using the drug EF5 to measure the oxygen level in tumor cells may help in planning cancer treatment

Detailed description: PRIMARY OBJECTIVES:

I. Determine the presence and pattern of etanidazole derivative EF5 binding with tumor, based on image and cellular analyses, in patients undergoing surgery or biopsy for newly diagnosed supratentorial malignant gliomas.

II. Determine the level of EF5 binding within histologic subtypes of this tumor in these patients.

Compare the relationship between hypoxia and clinical outcomes in patients with glioblastoma multiforme (GBM) vs non-GBM.

III. Determine the spatial relationships between EF5 binding and tumor tissue biomarkers and pathophysiologic processes (e.g., necrosis, proliferation, and apoptosis) in these patients.

IV. Determine the relationship between EF5 binding and Eppendorf needle electrode measurements in these patients.

OUTLINE:

Patients receive etanidazole derivative EF5 IV over 1-2½ hours once within 1-2 days before surgical resection or biopsy. Tumor tissue, normal tissue, and/or tumor-infiltrated lymph node samples are collected during surgery and stained for biological markers. Fluorescent immunohistochemistry techniques are used to determine the presence, distribution, and levels of EF5 binding.

Patients are followed at 1 month, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study within 1½-2 years.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed and/or clinical and imaging evidence of a new brain mass that is likely to be a supratentorial malignant glioma
* Clinical condition and physiologic status indicative of debulking surgery or biopsy as standard initial therapy
* Performance status - Karnofsky performance status 60-100%
* WBC greater than 2,000/mm\^3
* Platelet count greater than 90,000/mm\^3
* Creatinine less than 2.0 mg/dL
* No significant cardiac condition that would preclude study therapy
* No symptomatic congestive heart failure
* No unstable angina pectoris
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 1 month after study completion
* Weight no greater than 130 kilograms
* No grade 3 or 4 peripheral neuropathy
* No other invasive malignancy within the past 3 years that is likely to cause a solitary supratentorial metastasis
* No uncontrolled concurrent illness, medical condition, psychiatric illness, or social situation that would preclude study participation
* At least 6 months since prior chemotherapy
* Concurrent corticosteroid therapy allowed
* At least 6 months since prior radiotherapy to lesion or site of lesion
* At least 6 months since prior surgery to lesion or site of lesion except incisional or core biopsy
* Concurrent anticonvulsant therapy allowed
* No other concurrent investigational agents

Primary outcomes:
measure: Time to local recurrence
timeFrame: Time from study entry (EF5 administration) to local recurrence, assessed up to 3 years
Secondary outcomes:
measure: Time to death
timeFrame: Up to 3 years
measure: Presence and pattern of EF5 binding in newly diagnosed brain masses by IHC analyses
timeFrame: At 48 hours after EF5 administration
measure: Levels of EF5 binding within histological subtypes of SMG
timeFrame: At baseline, at 1 hour, and the time of surgery
measure: Relationship between hypoxia and clinical outcomes (i.e., time to local recurrence and survival)
timeFrame: Up to 3 years
measure: Association between EF5 binding and Eppendorf needle electrode measurements in brain masses
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of The University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Kevin Judy
role: PRINCIPAL_INVESTIGATOR
References: