Safety and Efficacy Study in Recurrent Grade IV Glioma

This is an interventional treatment trial for Glioblastoma Multiforme focused on measuring recurrent glioblastoma, recurrent GBM Read More

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 consent.

  • Phase 2a: Patient must have a confirmed IDH1 mutation reverse transcription polymerase chain reaction (rtPCR) or immunohistochemistry (unless continuing into the Phase 2a portion of the study from the Phase I portion of the study).

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 drug.
• 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.