Clinical Trial Details
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NCT02704858 : Safety and Efficacy Study in Recurrent Grade IV Glioma
PhasePhase 1/Phase 2
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

- 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
and radiation.

- 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
adequate contraception

- Must have the ability to understand, and the willingness to sign, a written informed

Exclusion Criteria:

- 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
study drug.

- 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.
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