Overview

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

Status:
Completed
Trial end date:
2010-05-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Cancer Institute (NCI)
Treatments:
Anticonvulsants
Epothilone B
Epothilones
Criteria
Inclusion Criteria:

- 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

Exclusion Criteria:

- 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