Status:
TERMINATED
Minocycline Therapy for Management of Adverse Radiation Effects
Lead Sponsor:
University of Pittsburgh
Conditions:
Irradiation; Adverse Effect
Eligibility:
All Genders
18-90 years
Phase:
PHASE1
Brief Summary
Stereotactic radiosurgery (SRS) is a well-established treatment for patients with metastatic brain tumors. Although SRS has a very high tumor growth control these interventions are associated with adv...
Detailed Description
Although stereotactic radiosurgery (SRS) has proven to be highly effective in the management of brain metastases, it is not without risk. Despite selective targeting of lesions and the sharp dose fall...
Eligibility Criteria
Inclusion
- 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
- 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 disorders;
Key Trial Info
Start Date :
November 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2018
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT02201563
Start Date
November 1 2015
End Date
May 31 2018
Last Update
June 25 2018
Active Locations (1)
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1
UPMC
Pittsburgh, Pennsylvania, United States, 15213