Bortezomib and Temozolomide in Treating Patients With Brain Tumors or Other Solid Tumors That Have Not Responded to Treatment
A Phase I Study of Bortezomib and Temozolomide in Patients With Refractory Solid Tumors
4 other identifiers
interventional
25
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jan 2005
Longer than P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 13, 2007
CompletedFirst Posted
Study publicly available on registry
October 16, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedFebruary 15, 2013
February 1, 2013
7 years
October 13, 2007
February 14, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dose-limiting toxicity and maximum tolerated dose
28 days
Secondary Outcomes (3)
Pharmacokinetics
Day 9
Confirmed complete or partial response
6 months
Percentage of patients with 6-month progression-free survival
6 months
Study Arms (1)
Treatment (temozolomide, bortezomib)
EXPERIMENTALGROUP 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).
Interventions
Eligibility Criteria
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:
- 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
- Patients enrolled on another clinical trial
- HIV-positive patients on antiretroviral therapy
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- City of Hope Medical Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (2)
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000, United States
City of Hope Medical Group
Pasadena, California, 91105, United States
Related Publications (1)
Portnow J, Frankel P, Koehler S, Twardowski P, Shibata S, Martel C, Morgan R, Cristea M, Chow W, Lim D, Chung V, Reckamp K, Leong L, Synold TW. A phase I study of bortezomib and temozolomide in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2012 Feb;69(2):505-14. doi: 10.1007/s00280-011-1721-x. Epub 2011 Aug 18.
PMID: 21850464DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jana Portnow, MD
City of Hope Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 13, 2007
First Posted
October 16, 2007
Study Start
January 1, 2005
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
February 15, 2013
Record last verified: 2013-02