Lymphoma Clinical Trial
Official title:
A Phase I Study of Bortezomib and Temozolomide in Patients With Refractory Solid Tumors
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.
OBJECTIVES:
Primary
- 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.
Secondary
- 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).
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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