Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Celtic Pharma Development Services
With
Neurobiological Technologies
XERECEPT® is not a potential treatment for cancer, but may reduce the edema associated with tumors and as a result, decrease neurological symptoms.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Participation in and completion of stipulated final follow-up periods for study NTI 0302, NTI 0303, or other designated studies.
Have a Karnofsky Performance of \> 50 at Baseline
Capable of self-administration of subcutaneous injections twice daily or availability of assistance from caregiver.
Ability to provide written informed consent or, if unable to provide, have a legal guardian or representative provide written informed consent.
For women of childbearing potential: a negative serum pregnancy test at Baseline
You may not be if
Concurrent enrollment in any investigational drug or device study, other than NTI 0302, NTI 0303, or other designated studies.
Systemic steroid use for any indication other than peritumoral brain edema.
Use or intended use of dexamethasone as an anti-emetic during study.
Clinical signs and symptoms of cerebral herniation.
Serious concomitant cardiovascular, pulmonary, renal, gastrointestinal or endocrine metabolic disease which could put the patient at unusual risk during study participation.
Confounding previous or concurrent neurological disorders that would interfere with adequate clinical evaluation.
Clinically significant head injury or chronic seizure disorder, if the condition results in functional impairment or is likely to interfere with evaluations.(Maintenance anticonvulsant therapy is allowed)
Central nervous system (CNS) infection.
Pregnancy, breastfeeding and/or refusal to practice birth control while in study, for women of childbearing potential.
