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An Open-Label, Phase 1/2A Dose Escalation Study of Safety and Efficacy of NEO100 in Recurrent Grade IV Glioma

Description

Brief Summary
NEO100-01 is a Phase 1/2A study of the monoterpene, perillyl alcohol (NEO100)in patients with recurrent glioblastoma. NEO100 is delivered four times a day by intranasal administration using a nebulizer and nasal mask for up to 6 months. Four escalating doses will be evaluated for tolerability, and the maximum tolerated dose will be extended in the 2A phase for a total of 25 patients. There is no concurrent control. This is the first nasal administration in the US, after prior oral studies with perillyl alcohol proved ineffective. Nasal administration of perillyl alcohol is on-going in Brazil


Detailed Description
Perillyl alcohol has previously been tested in 15 clinical studies in > 600 subjects This includes 13 studies in 255 subjects using oral administration sponsored by the National Cancer Institute and two studies in > 350 subjects using intranasal administration in Brazil. NEO100 is a highly purified (>99%) form of perillyl alcohol. Studies in Brazil suggest improved survival for patients with recurrent glioblastoma. Doses of 96 mg qid, 144mg qid, 192mg qid, and 288 mg qid administered intranasally to patients with recurrent GBM for up to 6 months, disease progression or death. From 3 to 6 patients will be evaluated after first cycle (28 days) until MTD is reached. MRI with gadolinium will be at base line, and at the beginning of even cycles. A total of 25 patients will be treated at the MTD. PK studies will be conducted during Phase 1 at first dosing, and after first dose of 3rd cycle.

Phase

Phase 1/2 - for trials that are a combination of phases 1 and 2.

Inclusion and Exclusion 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.

  • 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.

Sites

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