Bortezomib and Temozolomide in Treating Patients With Brain Tumors or Other Solid Tumors That Have Not Responded to Treatment

Completed · Phase 1

Conditions studied: Brain and Central Nervous System Tumors, Lymphoma, Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific

In brief

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.

Key facts

Study ID

NCT00544284

Run by

City of Hope Medical Center

People needed

25

Starts

2005-01-01

Expected to finish

2012-01-01

Last updated by the study team

2013-02-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Karnofsky performance status 60-100%
• Absolute neutrophil count ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Serum creatinine ≤ 1.5 x upper limit of normal (ULN)
• Total bilirubin ≤ 2.0 mg/dL
• AST ≤ 4.0 x ULN
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Patient must be able to understand and is willing to sign a written informed consent document

You may not qualify if…

• Any of the following conditions:
• Myocardial infarction within the past 6 months or New York Heart Association class III or IV heart failure
• Uncontrolled angina
• Severe uncontrolled ventricular arrhythmias
• ECG evidence of acute ischemia or active conduction system abnormalities
• Any ECG abnormalities prior to study entry must be documented by the investigator as not medically relevant
• Serious medical or psychiatric illness that would, in the opinion of the investigator, potentially interfere with the completion of treatment
• History of sensitivity to boron or mannitol
• PRIOR CONCURRENT THERAPY:
• Inclusion criteria:
• At least 4 weeks since prior chemotherapy (6 weeks for nitrosourea-containing chemotherapy), immunotherapy, or radiotherapy and recovered
• More than 10 days since prior anticonvulsant drugs that induce hepatic metabolic enzymes for patients in group A
• Recovered from major surgery
• Corticosteroids for cerebral edema allowed provided the patient is on a stable dose for at least 1 week
• Exclusion criteria:
• Patients enrolled on another clinical trial
• HIV-positive patients on antiretroviral therapy
• Concurrent chemotherapy or radiotherapy
• Patient requires anti-seizure medication but is not on a stable dose and agent of anti-seizure medication

Where it is running

• City of Hope Comprehensive Cancer Center — Duarte, California, United States
• City of Hope Medical Group — Pasadena, California, United States

Full record on ClinicalTrials.gov

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