Zoledronate in Preventing Osteoporosis in Patients With Primary Malignant Glioma
Condition: Brain Tumors; Osteoporosis; Central Nervous System(CNS)Malignancies
MeSH terms: Brain Neoplasms; Osteoporosis
Intervention: IV Zometa
Intervention description: Zometa will be given at 4 mg intravenously over 15 minutes every 3 months for 1 year.
Intervention MeSH terms: Zoledronic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: osteoporosis; adult anaplastic astrocytoma; adult giant cell glioblastoma; adult anaplastic oligodendroglioma; adult gliosarcoma; adult mixed glioma; recurrent adult brain tumor; adult glioblastoma

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.
    

Eligibility 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).