A Phase I/II Trial of BMS-247550 for Treatment of Patients With Recurrent High-Grade Gliomas

Completed · Phase 1/Phase 2

Conditions studied: Adult Anaplastic Astrocytoma, Adult Giant Cell Glioblastoma, Adult Gliosarcoma, Recurrent Adult Brain Tumor

In brief

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. This phase I/II trial is studying the side effects and best dose of ixabepilone and how well it works in treating patients with recurrent glioma.

Key facts

Study ID: NCT00045708
Run by: National Cancer Institute (NCI)
People needed: 57
Starts: 2002-10-01
Expected to finish: 2010-05-01
Last updated by the study team: 2017-10-18

Who can join

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

You may qualify if…

Patients must have histologically proven malignant glioma (anaplastic astrocytoma or glioblastoma multiforme) which is progressive or recurrent following radiation therapy +/- chemotherapy; patients with previous low grade glioma who progressed after radiotherapy +/- chemotherapy and are biopsied and found to have a high grade glioma are eligible
Patients must have measurable progressive or recurrent malignant glioma by MRI or CT imaging
Patients must have recovered from severe toxicity of prior therapy; an interval of at least 3 months must have elapsed since the completion of the most recent course of radiation therapy while at least 3 weeks must have elapsed since the completion of a non-nitrosourea containing chemotherapy regimen and at least 6 weeks since the completion of a nitrosourea containing chemotherapy regimen
Patients must have a Karnofsky performance status >= 60% (i.e. the patient must be able to care for himself/herself with occasional help from others)
Absolute neutrophil count >= 1500/mm\^3
Platelets >= 100,000/mm\^3
HgB > 9 g/dl
Creatinine =< 1.5mg/dl
Total Bilirubin =< 1.5mg/dl
Transaminases =< 2.5 times above the upper limits of the institutional norm)
Patients must be able to provide written informed consent
Patients must have =< 2 prior chemotherapy regimens
Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception; the anti-proliferative activity of this experimental drug may be harmful to the developing fetus or nursing infant; female patients of child-bearing potential must have a negative pregnancy test
Patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix and breast; patients with prior malignancies must be disease-free for >= five years
Patients must be maintained on a stable corticosteroid regimen from the time of their baseline scan until the start of treatment
Patients must have a Mini Mental State Exam score of >= 15

You may not qualify if…

Patients with serious concurrent infection or medical illness, which would jeopardize the ability of the patient to receive the treatment outlined in this protocol with reasonable safety
Patients who are pregnant or breast-feeding
Patients with more than 2 prior chemotherapy regimens
Patients receiving concurrent investigational agents
Patients receiving any of the following medications which are known to be moderate to significant inhibitors of CYP3A4 are not eligible:
Antibiotics: clarithromycin, erythromycin, troleandomycin
Anti-HIV agents: delavirdine, nelfinavir, amprenavir, ritonavir, indinavir, saquinavir, lopinavir
Antifungals: itraconazole, ketoconazole, fluconazole (doses > 200mg/day), voriconazole
Antidepressants: nefazodone, fluvoxamine
Calcium channel blockers: verapamil, diltiazem
Miscellaneous: amiodarone NOTE: The above list of agents was provided by the National Cancer Institute as moderate to significant inhibitors of CYP3A4 that should not be administered with BMS; there may be other agents that have similar activities on CYP3A4, however these are currently unspecified; if investigators are concerned about a particular medication's inhibitory effect on CYP3A4, they are encouraged to consult local pharmacy services for more information and to contact the principal investigator to discuss the situation further

Where it is running

Emory University — Atlanta, Georgia, United States
Johns Hopkins University — Baltimore, Maryland, United States
Massachusetts General Hospital — Boston, Massachusetts, United States
Wake Forest University — Winston-Salem, North Carolina, United States
Cleveland Clinic — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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