[Information provided by:
ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]
|NCT02704858 : Safety and Efficacy Study in Recurrent Grade IV Glioma|
|Phase||Phase 1/Phase 2|
|Ages||Min: 18 Years Max: N/A|
- Radiographically-confirmed progression of, or recurrent, primary or secondary Grade IV
glioma, and must be on a stable or decreasing dose of steroid for at least five days
prior to the date of informed consent.
- Must have failed previous radiation treatment or combined treatment with temozolomide
- If progression of disease occurs within three months of conformal radiation, it must
be outside of the radiation field or proven by biopsy/resection.
- Must have an ECOG performance status of 0 - 2, or KPS = 60.
- Must have an expected survival of at least three months.
- Must be willing to provide blood samples for pharmacokinetic study
- Must have adequate organ and marrow function
- Female patients of child-bearing potential and male patients must agree to use
- Must have the ability to understand, and the willingness to sign, a written informed
- The size of the Grade IV glioma tumor is multi-focal and > 30mm in size, as assessed
at the baseline (pre-study) MRI evaluation.
- Patient has completed chemo-radiation within the last three months, unless new
contrast enhancement is outside of radiation field, or there is tissue proven
recurrence or progression.
- Patient has had surgery within seven days prior to the date of informed consent.
- Patient has had chemotherapy within 28 days prior to first administration of study
- Patient has not recovered from adverse events due to chemotherapy, immunotherapy, or
radiation therapy administered more than 28 days prior to first administration of
- Patient has had prior treatment with bevacizumab, a chemotherapy wafer implant
(Gliadel), or any other FDA- approved chemotherapy except temozolomide.
- Patient has had more than one recurrence or progression of their tumors.
- Patient is receiving any other investigational agents.
- Patient has a history of allergic reactions attributed to perillyl alcohol.
- Patient has uncontrolled intercurrent illness
- Patient has a history of new diagnosis or treatment of cancer other than malignant
glioma within five years prior to start of the study, except for basal cell carcinoma
or squamous cell carcinoma.
|Links||Permanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02704858
| Link to official Clinicaltrials.gov listing