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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00110032
Other study ID # NCI-2012-02651
Secondary ID UPCC 01304CDR000
Status Terminated
Phase Phase 1
First received May 3, 2005
Last updated January 15, 2013
Start date June 2005

Study information

Verified date January 2013
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This phase I trial is studying the side effects of fluorine F18 EF5 when given during positron emission tomography to find oxygen in tumor cells of patients who are undergoing surgery or biopsy for newly diagnosed brain tumors. Diagnostic procedures using fluorine F 18 EF5 and positron emission tomography to detect tumor hypoxia may help in planning cancer treatment


Description:

PRIMARY OBJECTIVES:

I. Determine the safety of fluorine F 18 EF5 (^18F-EF5) in patients with newly diagnosed brain tumors undergoing surgery or biopsy.

Secondary I. Determine the pharmacokinetics and biodistribution of ^18F-EF5 administered before and after nonradioactive EF5 in these patients.

II. Determine the ability of positron emission tomography (PET) scanning using ^18F-EF5 to detect tumor hypoxia in these patients.

III. Determine the presence and pattern of nonradioactive EF5 binding by immunohistochemistry (IHC) and/or flow cytometry in these patients.

IV. Correlate tumor hypoxia, as measured by PET scanning using ^18F-EF5, with EF5 staining by IHC and/or flow cytometry and recurrence-free survival of these patients.

OUTLINE: Patients are assigned to 1 of 3 groups.

Group 1: Patients receive fluorine F 18 EF5 (^18F-EF5) IV followed by whole brain and whole body positron emission tomography (PET) scanning OR whole body PET scanning only. Patients then receive nonradioactive EF5 IV over 1-2 ½ hours.

Group 2: Patients receive nonradioactive EF5 IV over 1-2½ hours followed by ^18F-EF5 IV. Patients then undergo whole brain and whole body PET scanning.

Group 3: Patients receive nonradioactive EF5 and ^18F-EF5 as in group 2. Patients then undergo whole brain PET scanning. Approximately one day after EF5 administration, all patients undergo surgery or biopsy of the tumor AND biopsy of normal skin adjacent to the incision.

Patients are followed at 2-4 weeks and 4-6 weeks after EF5 administration and then every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.


Recruitment information / eligibility

Status Terminated
Enrollment 46
Est. completion date
Est. primary completion date January 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Histologically confirmed and/or clinical and imaging evidence of a de novo mass that is likely to be a brain tumor

- Amenable to debulking surgery or surgical resection or biopsy as standard initial therapy for the tumor

- Performance status - Karnofsky 70-100%

- At least 3 months

- WBC count = 2,000/mm^3

- Platelet count = 100,000/mm^3

- Bilirubin < 1.2 mg/dL

- Creatinine < 1.3 mg/dL

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia

- No other significant cardiac condition that would preclude study participation

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 1 month after study participation

- Weight = 130 kg

- No peripheral neuropathy = grade 3

- No history of allergic reaction attributed to metronidazole

- No other uncontrolled illness

- No psychiatric illness or social situation that would preclude study compliance

- No other medical condition that would preclude study participation

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms

  • Adult Anaplastic Astrocytoma
  • Adult Anaplastic Ependymoma
  • Adult Anaplastic Oligodendroglioma
  • Adult Brain Stem Glioma
  • Adult Central Nervous System Germ Cell Tumor
  • Adult Choroid Plexus Tumor
  • Adult Craniopharyngioma
  • Adult Diffuse Astrocytoma
  • Adult Ependymoblastoma
  • Adult Ependymoma
  • Adult Giant Cell Glioblastoma
  • Adult Glioblastoma
  • Adult Gliosarcoma
  • Adult Grade I Meningioma
  • Adult Grade II Meningioma
  • Adult Grade III Meningioma
  • Adult Medulloblastoma
  • Adult Meningeal Hemangiopericytoma
  • Adult Mixed Glioma
  • Adult Myxopapillary Ependymoma
  • Adult Oligodendroglioma
  • Adult Pilocytic Astrocytoma
  • Adult Pineoblastoma
  • Adult Pineocytoma
  • Adult Subependymoma
  • Adult Supratentorial Primitive Neuroectodermal Tumor (PNET)
  • Astrocytoma
  • Choroid Plexus Neoplasms
  • Craniopharyngioma
  • Ependymoma
  • Glioblastoma
  • Glioma
  • Gliosarcoma
  • Hemangiopericytoma
  • Medulloblastoma
  • Meningeal Melanocytoma
  • Meningioma
  • Neoplasms
  • Neuroectodermal Tumors
  • Neuroectodermal Tumors, Primitive
  • Oligodendroglioma
  • Solitary Fibrous Tumors

Intervention

Drug:
EF5
Given IV
Procedure:
conventional surgery
Undergo surgery
positron emission tomography
Undergo PET
Radiation:
fluorine F 18 EF5
Given IV
Other:
pharmacological study
Correlative studies

Locations

Country Name City State
United States Abramson Cancer Center of The University of Pennsylvania Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety of F-18-EF5 based on the NCI CTCAE version 3.0 Summarized in descriptive statistics. Up to 3 years Yes
Secondary Pharmacokinetics of radioactively labeled [F-18]-EF5 Day 1 No
Secondary Extent of hypoxia, determined by [F-18]-EF5 PET imaging Up to day 1 No
Secondary IHC analysis of cold EF5 Up to day 1 No
Secondary Progression-free survival Up to 6 years No
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