Use of EF5 to Measure the Oxygen Level in Tumor Cells of Patients Undergoing Surgery or Biopsy for Newly Diagnosed Supratentorial Malignant Glioma

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Etanidazole; Imidazole

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