Bortezomib in Treating Patients With Recurrent Glioma
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Adult Anaplastic Astrocytoma Adult Anaplastic Oligodendroglioma Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma Recurrent Adult Brain Tumor |
Drug: bortezomib |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Evaluation of the Safety of PS 341 in the Treatment of Recurrent Gliomas |
- Maximum tolerated dose of bortezomib defined as the dose level below that at which > 1 of 3-6 patients experience DLT [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]Graded using the CTC version 2.0.
- Biological effectiveness estimated using 20S proteosome activity [ Time Frame: Up to 6 years ] [ Designated as safety issue: No ]Simple descriptive measures will be used to examine the association between biological effect and the probability of toxicity and response.
- Frequency of toxicity, graded using the CTC version 2.0 [ Time Frame: Up to 6 years ] [ Designated as safety issue: Yes ]The proportion of patients with serious or life threatening toxicities will be estimated along with 95% confidence intervals.
| Enrollment: | 42 |
| Study Start Date: | May 2001 |
| Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment (bortezomib)
Patients receive bortezomib IV over 3-5 seconds twice weekly for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
|
Drug: bortezomib
Given IV
Other Names:
|
Detailed Description:
OBJECTIVES:
I. Determine the maximum tolerated dose of bortezomib with or without anticonvulsant drugs known to be metabolized by the P450 hepatic enzyme complex in patients with recurrent glioma.
II. Determine the biologic activity of this drug by measuring proteasome 20S activity in these patients.
III. Determine the effects of hepatic enzyme-inducing drugs, such as anticonvulsants, on biologic activity of this drug in these patients.
OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to concurrent anticonvulsant drug use (phenytoin, carbamazepine, phenobarbital, primidone, or felbamate vs gabapentin, lamotrigine, valproic acid, or no anticonvulsant drugs).
Patients receive bortezomib IV over 3-5 seconds twice weekly for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 10 additional patients are treated with bortezomib at the MTD. Patients are followed every 2 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Maryland | |
| New Approaches to Brain Tumor Therapy Consortium | |
| Baltimore, Maryland, United States, 21231-1000 | |
| Principal Investigator: | Jeffrey Olson | New Approaches to Brain Tumor Therapy Consortium |
More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00006773 History of Changes |
| Other Study ID Numbers: | NCI-2012-02367, NABTT-9910, U01CA062475, CDR0000068326 |
| Study First Received: | December 6, 2000 |
| Last Updated: | January 23, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Astrocytoma Brain Neoplasms Glioblastoma Oligodendroglioma Gliosarcoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Brain Diseases Central Nervous System Diseases Nervous System Diseases Bortezomib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013