Zoledronate in Preventing Osteoporosis in Patients With Primary Malignant Glioma

NCT00301873 | Completed Phase 2 Results DMC

• 2 other identifiers: Pro00010125P50NS020023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brain Tumors; Osteoporosis; Central Nervous System(CNS)Malignancies

Keywords

osteoporosis; adult anaplastic astrocytoma; adult giant cell glioblastoma; adult anaplastic oligodendroglioma; adult gliosarcoma; adult mixed glioma; recurrent adult brain tumor; adult glioblastoma

Outcome Measures

Primary Outcomes (1)

• Percent of Patients With Change in Combined Bone Mass Density T-score <= -0.5.

  Percent of patients who failed treatment as defined by a decrease of 0.5 or more from baseline in the combined T-score as measured by Dexa-scan. The patient's bone densitometry was determined by Dexa-scan at baseline, after 6 months of Zometa and after 1 year of Zometa. The t-score, which is a comparison of a person's bone density with that of a healthy 30-year-old of the same sex, was generated by Dexa-scan for the spine and femur. The combined T-score is the minimum of the T-score for the spine and femur. A lower t-score implies a lower BMD.

  6 and 12 months

Secondary Outcomes (2)

• Skeletal-related Complications

  1 year

• Mean Change in Bone Mass Density (BMD)

  6 & 12 months

Study Arms (1)

IV Zometa

EXPERIMENTAL

Zometa will be given at 4 mg intravenously over 15 minutes every 3 months for 1 year.

Drug: IV Zometa

Interventions

IV Zometa DRUG

Zometa will be given at 4 mg intravenously over 15 minutes every 3 months for 1 year.

Also known as: zolondronic acid

IV Zometa

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically confirmed diagnosis of a primary brain tumor.
• Patients must be on Depakote ( Valproic Acid) or one of the following enzyme inducing anticonvulsants (EIAC) therapies. Phenobarbital, Dilantin, Trileptal, Tegretol and/or on more than physiologic replacement steroid therapy (Dexamethasone \>0.75 mg/d, prednisone \>5 mg/d or hydrocortisone \>20 mg/d).
• Age \> 18 years.
• Karnofsky performance score \> 60%
• Adequate renal and liver function as demonstrated by laboratory values performed within 14 days, inclusive, prior to the administration of Zometa, except for the creatinine, which will be within 72 hs of Zometa administration:
• Serum creatinine \< 2.0 mg/dl and calculated creatinine clearance of \>60 mL/min
• Total serum bilirubin \< 1.5 times upper limit of laboratory normal
• Serum glutamoc-oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) \< 2.5 times upper limit of laboratory normal
• Alkaline phosphatase of \<2 times upper limit of laboratory normal
• Patients must have recovered from any effects of major surgery.
• Patients must have a life expectancy of greater than 12 weeks.
• Patients or legal guardian must give written, informed consent.

You may not qualify if:

• Patients who are poor medical risks because of non-malignant systemic disease as well as those with acute infection treated with intravenous antibiotics.
• Previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-situ of the cervix and basal or squamous cell carcinoma of the skin.
• Known HIV positivity or AIDS-related illness.
• Pregnant or nursing women.
• Women of childbearing potential who are not using an effective method of contraception. Women of childbearing potential must have a negative serum pregnancy test 72hours prior to administration of study and be practicing medically approved contraceptive precautions.
• Men who are not advised to use and effective method of contraception.
• Patients previously diagnosed with osteoporosis requiring oral bisphosphonates.
• Known hypersensitivity to Zometa® (zoledronic acid) or other bisphosphonates
• Current active dental problems including infection of the teeth or jawbone osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures.
• Recent (within 6 weeks) or planned dental or jaw surgery (e.g.. extraction, implants).

Sponsors & Collaborators

• Duke University: lead
• Novartis: collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Brain Neoplasms; Osteoporosis; Astrocytoma; Glioblastoma; Oligodendroglioma; Gliosarcoma; Glioma

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Limitations include early pt termination leading to small numbers of subjects analyzed (eg no BMD study at 6 and/or 12 mos)secondary to the poor overall survival (eg median survival 3-9 mos)associated with recurrent glioblastoma multiforme(GBM) pts.

Results Point of Contact

• Title: Mary Lou Affronti, RN, MSN, ANP, MHSc Senior Investigator
• Organization: Duke Comprehensive Cancer Center

mary.affronti@duke.edu

919-684-6239

Study Officials

• James J. Vredenburgh, MD

  Duke University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2006
• First Posted: March 13, 2006
• Study Start: May 1, 2006
• Primary Completion: February 1, 2011
• Study Completion: September 1, 2012
• Last Updated: February 18, 2013
• Results First Posted: January 16, 2013

Record last verified: 2013-02

Locations

US (1)