Adult Glioblastoma Clinical Trial
Official title:
Phase I Evaluation of the Safety of PS 341 in the Treatment of Recurrent Gliomas
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
Status | Terminated |
Enrollment | 42 |
Est. completion date | |
Est. primary completion date | June 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | New Approaches to Brain Tumor Therapy Consortium | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum tolerated dose of bortezomib defined as the dose level below that at which > 1 of 3-6 patients experience DLT | Graded using the CTC version 2.0. | 3 weeks | Yes |
Secondary | Biological effectiveness estimated using 20S proteosome activity | Simple descriptive measures will be used to examine the association between biological effect and the probability of toxicity and response. | Up to 6 years | No |
Secondary | Frequency of toxicity, graded using the CTC version 2.0 | The proportion of patients with serious or life threatening toxicities will be estimated along with 95% confidence intervals. | Up to 6 years | Yes |
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