Bortezomib and Temozolomide in Treating Patients With Brain Tumors or Other Solid Tumors That Have Not Responded to Treatment
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|ClinicalTrials.gov Identifier: NCT00544284|
Recruitment Status : Completed
First Posted : October 16, 2007
Last Update Posted : February 15, 2013
RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with temozolomide may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when given together with temozolomide in treating patients with brain tumors or other solid tumors that have not responded to treatment.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors Lymphoma Metastatic Cancer Unspecified Adult Solid Tumor, Protocol Specific||Drug: bortezomib Drug: temozolomide Other: pharmacological study||Phase 1|
- To determine the dose-limiting toxicities and maximum tolerated doses of bortezomib and temozolomide in patients with recurrent high-grade gliomas, recurrent metastatic brain tumors, or other refractory solid tumors.
- To evaluate the pharmacokinetics of bortezomib in patients taking hepatic enzyme-inducing anticonvulsants (Group A) and in those who are not (Group B).
- To describe the proportion of study patients treated with bortezomib and temozolomide who obtain a confirmed complete response or partial response.
- To report the percentage of patients with 6-month progression-free survival.
OUTLINE: Patients are stratified according to concurrent hepatic enzyme-inducing anticonvulsants (HEIAs) (Group A) versus concurrent anticonvulsant drugs that cause modest or no induction of hepatic metabolic enzymes OR no anticonvulsant drugs (Group B).
- Group A: Patients receive oral temozolomide once a day on days 1-5 and bortezomib IV on days 2, 5, 9, and 12. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- Group B: Patients receive temozolomide and bortezomib as in group A. Cohorts of patients in both groups receive escalating doses of both study drugs until the maximum tolerated doses are determined.
All patients undergo blood sample collection periodically for pharmacokinetic studies. Samples are analyzed for bortezomib concentration (groups A and B) and trough levels of anticonvulsants (group A only).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of Bortezomib and Temozolomide in Patients With Refractory Solid Tumors|
|Study Start Date :||January 2005|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||January 2012|
Experimental: Treatment (temozolomide, bortezomib)
GROUP A: Patients receive oral temozolomide once a day on days 1-5 and bortezomib IV on days 2, 5, 9, and 12. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. GROUP B: Patients receive temozolomide and bortezomib as in group A. Cohorts of patients in both groups receive escalating doses of both study drugs until the maximum tolerated doses are determined. All patients undergo blood sample collection periodically for pharmacokinetic studies. Samples are analyzed for bortezomib concentration (groups A and B) and trough levels of anticonvulsants (group A only).
|Drug: bortezomib Drug: temozolomide Other: pharmacological study|
- Dose-limiting toxicity and maximum tolerated dose [ Time Frame: 28 days ]
- Pharmacokinetics [ Time Frame: Day 9 ]
- Confirmed complete or partial response [ Time Frame: 6 months ]
- Percentage of patients with 6-month progression-free survival [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00544284
|United States, California|
|City of Hope Comprehensive Cancer Center|
|Duarte, California, United States, 91010-3000|
|City of Hope Medical Group|
|Pasadena, California, United States, 91105|
|Principal Investigator:||Jana Portnow, MD||City of Hope Comprehensive Cancer Center|