Clinical Trial Details
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NCT02201563 : Minocycline Therapy for Management of Adverse Radiation Effects
PhasePhase 1
AgesMin: 18 Years Max: 90 Years
Inclusion Criteria:

- Age range: 18 - 90 years

- Males and females.

- Patients must have undergone cranial radiosurgery.

- MRI evidence supporting the diagnosis of ARE and/or surgical biopsy evidence of
necrosis without tumor at ?2 months before study entry.

- Karnofsky performance status of ?60,

- With or without evidence of progressive neurologic signs or symptoms appropriate to
the location of the ARE, and no previous bevacizumab therapy.

- With or without previous chemotherapy for their tumor.

- Routine laboratory study results with bilirubin ?1.5 times the upper limit of normal,
aspartate aminotransferase and/or alanine aminotransferase <2.5 times the upper limit
of normal, creatinine <2.0 times the upper limit of normal.

- Patients with a history of seizures will be required to be receiving anticonvulsant
therapy and to be seizure-free for ?1 week before study.

Exclusion Criteria:

- Significant mass effect requiring resection (as assessed by a clinical neurosurgeon)

- Known hypersensitivity to tetracyclines

- Women of childbearing age must be non-lactating and have a negative urine pregnancy
test (adequate birth control includes use of intra uterine device, or a barrier
method, e.g. condom, diaphragm). The results of animal studies indicate that
tetracyclines cross the placenta and are found in fetal tissues, having potentially
toxic effects on the developing fetus (often related to retardation of skeletal
development). Evidence of embryo toxicity has been noted in animals treated early in
pregnancy. Therefore pregnant women will not be allowed to participate in this study

- Female subjects on oral contraceptives

- Contraindication to undergo MRI

- Significant cardiopulmonary, renal or neurological co-morbidities

- Current diagnosis of major depression, substance abuse, or other psychiatric
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