Bortezomib in Treating Patients With Recurrent Glioma

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

Summary

Phase I trial to study the effectiveness of bortezomib in treating patients who have recurrent glioma. Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Bortezomib

Criteria

Inclusion Criteria:

• Histologically confirmed progressive or recurrent malignant glioma

• Anaplastic astrocytoma

• Anaplastic oligodendroglioma

• Glioblastoma multiforme

• Prior low-grade gliomas that have progressed to high-grade after therapy allowed

• Measurable disease by MRI or CT scan

• Performance status - Karnofsky 60-100%

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

• Bilirubin no greater than 1.5 mg/dL

• Transaminases no greater than 4 times upper limit of normal

• Creatinine no greater than 1.7 mg/dL

• Mini mental score at least 15

• No concurrent serious infection or other medical illness that would preclude study participation

• No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 3 months after study participation

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered

• No more than 1 prior chemotherapy regimen

• At least 3 months since prior radiotherapy and recovered

• No other concurrent investigational agents