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6G-15-2: An Open-Label, Phase 1/2a Dose Escalation Study of Safety and Efficacy of NEO100 in Recurrent Grade IV Glioma

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
  • Must have failed previous radiation treatment or combined treatment with temozolomide and radiation.
  • 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.

  • 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 one week prior to study entry, or chemotherapy within the last four weeks
  • 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.

Sites

Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.

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