A Phase 1 interventional study of bortezomib and temozolomide in Brain and Central Nervous System Tumors, Lymphoma and Metastatic Cancer, sponsored by City of Hope Medical Center. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-02-15.
Sponsored by City of Hope Medical Center · Phase 1, Interventional, and Treatment
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
Secondary
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).
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).
9,359 studies on the registry are indexed under Neoplasms; 2,486 are open to participants now.
This study's enrollment of 25 is below the median of 50 across 7,250 interventional studies indexed under Neoplasms.
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DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed solid tumors including the following
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
Any of the following conditions:
ECG evidence of acute ischemia or active conduction system abnormalities
PRIOR CONCURRENT THERAPY:
Inclusion criteria:
Recovered from major surgery
Exclusion criteria:
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
This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.
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City of Hope Medical Center