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A Phase II Trial Evaluating the Effects of Bortezomib in Patients With Recurrent Malignant Gliomas Treated Prior to Surgery and Then Bortezomib and Temozolomide Post-operatively

Phase 2
18 Years
Open (Enrolling)
Brain and Central Nervous System Tumors

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Trial Information

A Phase II Trial Evaluating the Effects of Bortezomib in Patients With Recurrent Malignant Gliomas Treated Prior to Surgery and Then Bortezomib and Temozolomide Post-operatively

Patients receive bortezomib IV on days 1, 4, and 8. Patients then undergo surgical resection
of the tumor on day 8 or 9.

Beginning approximately 14 days after surgery, patients receive oral temozolomide on days
1-7 and 14-21 and bortezomib IV on days 7 and 21. Treatment repeats every 28 days for up to
2 years in the absence of disease progression or unacceptable toxicity.

Tumor tissue and blood samples are collected periodically for biomarker analysis, gene
methylation studies, and pharmacokinetic studies.

After completion of study therapy, patients are followed up every 3 months for 2 years.

Inclusion Criteria:

- Histologically confirmed malignant glioma, including any of the following subtypes:

- Glioblastoma multiforme

- Gliosarcoma

- Anaplastic astrocytoma

- Anaplastic oligodendroglioma

- Anaplastic mixed oligoastrocytoma

- Malignant astrocytoma not otherwise specified

- Must show unequivocal evidence of tumor recurrence or progression by MRI or CT scan
with contrast

- Candidate for surgery AND requires surgery

- Evaluable or measurable disease following resection of recurrent tumor is not

- Failed prior standard radiotherapy and temozolomide

- Patients who have undergone stereotactic radiosurgery must have confirmation of
true progressive disease (rather than radiation necrosis) by PET scan, magnetic
resonance spectroscopy (MRS), or magnetic resonance perfusion (MRP) prior to

- Patients with lower-grade gliomas that have undergone radiographic malignant
transformation allowed provided they failed radiotherapy (with or without
temozolomide) and require surgery

- Life expectancy > 12 weeks

Exclusion Criteria:

- Not pregnant or nursing

- Negative pregnancy test

- No other medical issues (e.g., bleeding, infection, HIV, or serious medical or
psychiatric illness) that would preclude study therapy

- Myocardial infarction within the past 6 months

- No other active cancer(s) except non-melanoma skin cancer or carcinoma in situ of the
cervix, unless in complete remission and off of all therapy for that cancer for ≥ 3

- No hypersensitivity to bortezomib, boron, or mannitol

- More than 4 weeks since prior radiotherapy

- At least 4 weeks since prior cytotoxic therapy (6 weeks for nitrosoureas)

- At least 3 weeks since prior investigational drugs

- At least 2 weeks since prior enzyme-inducing anticonvulsants

- Concurrent non-enzyme-inducing anticonvulsants allowed

- No other concurrent standard or investigational anticancer treatment

Type of Study:


Study Design:

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

Outcome Measure:

Correlative Profiles with therapy response and patient survival.

Outcome Description:

To determine the effects of Bortezomib on the endogenous modulators of NF-Kappa B pathways, especially NFKBIA, via novel assay technology, and correlate profiles with therapy response and patient survival.

Outcome Time Frame:

Samples drawn pre-surgery, Bortezomib treatment day 1, Drawn prior to surgery, Day prior to treatment post surgery, and Day of MRI every cycle POST-surgery, tissue evaluated at study completion

Safety Issue:


Principal Investigator

Jeffrey Raizer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Northwestern University


United States: Food and Drug Administration

Study ID:

NU 08C5



Start Date:

May 2009

Completion Date:

May 2014

Related Keywords:

  • Brain and Central Nervous System Tumors
  • brain tumor
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms
  • Glioma



Northwestern University Chicago, Illinois  60611