Zoledronate in Preventing Osteoporosis in Patients With Primary Malignant Glioma

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS); Novartis
• Treatments: Zoledronic Acid

Criteria

Inclusion Criteria:

1. Patients must have histologically confirmed diagnosis of a primary brain tumor.

2. 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).

3. Age > 18 years.

4. Karnofsky performance score > 60%

5. 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

6. Patients must have recovered from any effects of major surgery.

7. Patients must have a life expectancy of greater than 12 weeks.

8. Patients or legal guardian must give written, informed consent.

Exclusion Criteria:

1. Patients who are poor medical risks because of non-malignant systemic disease as well as those with acute infection treated with intravenous antibiotics.

2. 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.

3. Known HIV positivity or AIDS-related illness.

4. Pregnant or nursing women.

5. 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.

6. Men who are not advised to use and effective method of contraception.

7. Patients previously diagnosed with osteoporosis requiring oral bisphosphonates.

8. Known hypersensitivity to Zometa® (zoledronic acid) or other bisphosphonates

9. 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.

10. Recent (within 6 weeks) or planned dental or jaw surgery (e.g.. extraction, implants).