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Assessment of Hypoxia in Malignant Gliomas Using EF5


N/A
18 Years
N/A
Not Enrolling
Both
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

Thank you

Trial Information

Assessment of Hypoxia in Malignant Gliomas Using EF5


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Time to local recurrence

Outcome Time Frame:

Time from study entry (EF5 administration) to local recurrence, assessed up to 3 years

Safety Issue:

No

Principal Investigator

Kevin Judy

Investigator Role:

Principal Investigator

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02419

NCT ID:

NCT00430079

Start Date:

July 2001

Completion Date:

Related Keywords:

  • 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
  • Astrocytoma
  • Ependymoma
  • Glioblastoma
  • Glioma
  • Oligodendroglioma
  • Glioma, Subependymal
  • Gliosarcoma

Name

Location

Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283