Zoledronate in Preventing Osteoporosis in Patients With Primary Malignant Glioma - Full Text View

Sponsors and Collaborators:	Duke University National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00301873

Purpose

RATIONALE: Zoledronate may prevent bone loss in patients with primary malignant glioma.

PURPOSE: This phase II trial is studying how well zoledronate works in preventing osteoporosis in patients with primary malignant glioma.

Condition	Intervention	Phase
Brain and Central Nervous System Tumors Cancer-Related Problem/Condition	Drug: zoledronic acid	Phase II

MedlinePlus related topics: Brain Cancer Cancer Osteoporosis

Drug Information available for: Zoledronic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Open Label
Official Title:	Phase II Study of Zometa (Zoledronic Acid) to Prevent Osteoporosis in Patients With Brain Tumors

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

Primary Outcome Measures:

Efficacy in terms of decreasing the incidence and severity of osteoporosis

Secondary Outcome Measures:

Tolerability
Skeletal-related complications

Estimated Enrollment:	50
Study Start Date:	May 2006

Detailed Description:

OBJECTIVES:

Primary

Determine the efficacy of zoledronate (zoledronic acid), in terms of decreasing the incidence and severity of osteoporosis, in patients with high-grade primary malignant glioma.

Secondary

Assess the tolerability of zoledronate (zoledronic acid) in these patients.
Determine any skeletal-related complications in patients treated with zoledronate (zoledronic acid).

OUTLINE: This is an open-label study

Patients receive zoledronate (zoledronic acid) IV over 15 minutes on day 1. Treatment repeats every 3 months for 1 year.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Eligibility

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

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed primary malignant glioma (WHO grade III or IV) by biopsy or resection, including the following:
- Anaplastic astrocytoma
- Glioblastoma multiforme
- Anaplastic oligodendroglioma
- Gliosarcoma
- Anaplastic mixed oligoastrocytoma

PATIENT CHARACTERISTICS:

Life expectancy > 12 weeks
Karnofsky performance status (PS) 70-100%
Creatinine < 2.0 mg/dL
Creatinine clearance > 60 mL/min
Bilirubin < 1.5 times upper limit of normal (ULN)
SGOT and SGPT < 2.5 times ULN
Alkaline phosphatase < 2 times ULN
No other prior or concurrent malignancies except basal cell or squamous cell carcinoma of the skin or surgically cured carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
Patients must be receiving enzyme-inducing anticonvulsants (e.g., valproic acid, phenobarbital, phenytoin, oxycarbazepine, or carbamazepine) and/or > physiologic replacement steroid therapy (e.g., dexamethasone > 0.75 mg/day, prednisone > 5 mg/day, or hydrocortisone > 20 mg/day)
Recovered from prior major surgery

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00301873

Locations

United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710

Sponsors and Collaborators

Duke University

National Cancer Institute (NCI)

Investigators

Study Chair:

James J. Vredenburgh, MD

Duke University

More Information

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

Study ID Numbers:	CDR0000463720, DUMC-7676-05-9R0, NOVARTIS-DUMC-7676-05-9R0
Study First Received:	March 9, 2006
Last Updated:	November 22, 2008
ClinicalTrials.gov Identifier:	NCT00301873
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

osteoporosis
adult anaplastic astrocytoma
adult giant cell glioblastoma
adult anaplastic oligodendroglioma

adult gliosarcoma
adult mixed glioma
recurrent adult brain tumor
adult glioblastoma

Study placed in the following topic categories:

Glioblastoma
Zoledronic acid
Astrocytoma
Osteoporosis
Bone Diseases, Metabolic
Central Nervous System Neoplasms
Bone Diseases

Recurrence
Brain Neoplasms
Musculoskeletal Diseases
Oligodendroglioma
Glioma
Gliosarcoma
Nervous System Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Physiological Effects of Drugs

Nervous System Diseases
Bone Density Conservation Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009