Ixabepilone in Treating Patients With Recurrent Glioma - Full Text View

Sponsor:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00045708

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: 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.

Condition	Intervention	Phase
Brain and Central Nervous System Tumors	Drug: ixabepilone	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Phase I/II Trial of BMS-247550 for Treatment of Patients With Recurrent High-Grade Gliomas

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Ixabepilone

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Maximum tolerated dose [ Designated as safety issue: Yes ]
Pharmacokinetics [ Designated as safety issue: No ]
Response rate [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]
Progression-free survival at 6 months [ Designated as safety issue: No ]
Duration of progression-free survival [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]

Study Start Date:	October 2002
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Determine the maximum tolerated dose of ixabepilone in patients with recurrent high-grade glioma who are receiving or not receiving cytochrome P450-inducing anticonvulsants.
Determine the pharmacokinetics of this drug in these patients.
Determine the response rate of patients treated with this drug.
Determine the toxicity of this drug in these patients.
Determine the 6-month progression-free survival, duration of progression-free survival, and overall survival of patients treated with this drug.

OUTLINE: This is a phase I, dose-escalation, multicenter study followed by a phase II, safety and efficacy, multicenter study. For phase I only, patients are stratified according to cytochrome P450-inducing anticonvulsant use (yes vs no).

Phase I: Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity.

Phase II: Once the MTD is determined, additional patients receive ixabepilone as above at the MTD.

Patients are followed every 2 months.

PROJECTED ACCRUAL: A minimum of 10-15 patients will be accrued for the phase I portion of this study. A total of 22-33 patients will be accrued for the phase II portion of this study within 4-6 months.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed malignant glioma
- Anaplastic astrocytoma, glioblastoma multiforme, anaplastic oligodendroglioma, or anaplastic mixed glioma
- Recurrent or progressive after radiotherapy with or without chemotherapy
- Prior low-grade glioma that has progressed to high-grade glioma allowed
Measurable disease by MRI or CT scan

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

Karnofsky 60-100%

Life expectancy

Not specified

Hematopoietic

Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
Hemoglobin greater than 9 g/dL

Hepatic

Bilirubin no greater than 1.5 mg/dL
AST/ALT no greater than 2.5 times upper limit of normal

Renal

Creatinine no greater than 1.5 mg/dL

Other

Mini mental score at least 15
No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast
No concurrent serious infection or medical illness that would preclude study therapy
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

See Disease Characteristics
No more than 2 prior chemotherapy regimens
At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas)

Endocrine therapy

Not specified

Radiotherapy

See Disease Characteristics
At least 3 months since prior radiotherapy

Surgery

Not specified

Other

Recovered from prior therapy
No other concurrent investigational agents
No concurrent moderate to significant inhibitors of CYP3A4, including any of the following:
- Clarithromycin
- Erythromycin
- Troleandomycin
- Delaviridine
- Nelfinavir
- Amprenavir
- Ritonavir
- Indinavir
- Saquinavir
- Lopinavir
- Itraconazole
- Ketoconazole
- Fluconazole (doses > 200 mg/day)
- Voriconazole
- Verapamil
- Diltiazem
- Amiodarone
- Nefazodone
- Fluoroxamine

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00045708

Locations

United States, Alabama
Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States, 33612-9497
United States, Georgia
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231
United States, Massachusetts
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114-2617
United States, Michigan
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, North Carolina
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1030
United States, Ohio
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair:

David M. Peereboom, MD

The Cleveland Clinic

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Peerebom D, Batchelor T, Lesser G, et al.: NABTT 2111: a phase I trial of BMS-247550 for patients with recurrent high-grade gliomas. [Abstract] J Clin Oncol 23 (Suppl 16): A-1563, 129s, 2005.

Study ID Numbers:	CDR0000257118, NABTT-2111, JHOC-NABTT-2111
Study First Received:	September 6, 2002
Last Updated:	April 29, 2009
ClinicalTrials.gov Identifier:	NCT00045708 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adult anaplastic astrocytoma
adult glioblastoma
recurrent adult brain tumor
adult anaplastic oligodendroglioma

adult mixed glioma
adult giant cell glioblastoma
adult gliosarcoma

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Epothilones
Mitosis Modulators
Neoplasms, Nerve Tissue
Nervous System Diseases
Antimitotic Agents
Central Nervous System Neoplasms
Pharmacologic Actions

Neuroectodermal Tumors
Neoplasms
Neoplasms by Site
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Tubulin Modulators
Glioma
Neoplasms, Neuroepithelial
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 09, 2009