Status:
COMPLETED
Presurgery Bortezomib for Recurrent Malignant Gliomas Followed by Postop Bortezomib & Temozolomide
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
Millennium Pharmaceuticals, Inc.
Conditions:
Brain and Central Nervous System Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tum...
Detailed Description
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 temozolom...
Eligibility Criteria
Inclusion
- 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 required
- 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 surgery
- 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
- 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 years
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00990652
Start Date
May 1 2009
End Date
October 1 2012
Last Update
January 13 2014
Active Locations (1)
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1
Northwestern University
Chicago, Illinois, United States, 60611