Safety and Efficacy Study in Recurrent Grade IV Glioma
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02704858 |
Recruitment Status
:
Recruiting
First Posted
: March 10, 2016
Last Update Posted
: September 14, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Glioblastoma Multiforme | Drug: Perillyl alcohol | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 43 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open-Label, Phase 1/2A Dose Escalation Study of Safety and Efficacy of NEO100 in Recurrent Grade IV Glioma |
Study Start Date : | April 2016 |
Estimated Primary Completion Date : | June 2018 |
Estimated Study Completion Date : | October 2018 |
Arm | Intervention/treatment |
---|---|
Experimental: NEO100
Intranasal delivery of NEO100 (perillyl alcohol) four times a day, escalation up to four different doses to determine maximum tolerated dose. Followed by treatment of total of 25 patients at maximum tolerated dose
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Drug: Perillyl alcohol
Intranasal administration
Other Name: NEO100
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- Phase 1 Primary Outcome: Number of Participants with Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment [ Time Frame: Up to 6 months ]
- Phase 2 Primary Outcome: Number of Participants Who Are Alive Each Month For 6 Months [ Time Frame: Up to 6 months ]
- Phase 2 Primary Outcome: Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related To Treatment [ Time Frame: 6 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02704858
Contact: Laurie Mellott | 949-428-6650 | laurie.mellott@clindatrix.com | |
Contact: Sally Hafez, MD | 949-428-6618| | sally.hafez@clindatrix.com |
United States, California | |
University of Southern California | Recruiting |
Los Angeles, California, United States, 90033 | |
Contact: Aida Lozada 323-865-3980 Aida.Lozada@med.usc.edu | |
Principal Investigator: Naveed Wagle, MD | |
United States, Florida | |
Cleveland Clinic Florida | Not yet recruiting |
Weston, Florida, United States, 33331 | |
Contact: Abel Rodriguez 954-487-2258 rodriga2@ccf.org | |
Principal Investigator: Bruno Bastos, MD | |
United States, Ohio | |
Cleveland Clinic | Recruiting |
Cleveland, Ohio, United States, 44333 | |
Contact: Teresa Allison 216-444-6459 allisot@ccf.org | |
Contact: Theresa Naska 216-444-8923 naskat@ccf.org | |
Principal Investigator: David Peereboom, MD | |
United States, Washington | |
University of Washington Seattle Cancer Care Alliance | Not yet recruiting |
Seattle, Washington, United States, 98109 | |
Contact: Ana Valeria Martin 206-221-1538 avmartin@uw.edu | |
Contact: Bryan Kim 206-543-4069 bkim500@uw.edu | |
Principal Investigator: Lynne Taylor, MD | |
United States, Wisconsin | |
University of Wisconsin Hospital and Clinic | Recruiting |
Madison, Wisconsin, United States, 53792 | |
Contact: Diana Trask 608-263-9528 trask@humonc.wisc.edu | |
Contact: Belinda BuehlSoppe 608-265-9958 bkbuehl@humonc.wisc.edu | |
Principal Investigator: Steve Howard, MD |
Study Chair: | Tom Chen, MD, PhD | NeOnc Technologies | |
Study Director: | Vincent F Simmon, PhD | NeOnc Technologies | |
Study Director: | Patrick Walters | NeOnc Technologies |
Responsible Party: | Neonc Technologies, Inc. |
ClinicalTrials.gov Identifier: | NCT02704858 History of Changes |
Other Study ID Numbers: |
NEO100-01 |
First Posted: | March 10, 2016 Key Record Dates |
Last Update Posted: | September 14, 2017 |
Last Verified: | September 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Keywords provided by Neonc Technologies, Inc.:
recurrent glioblastoma recurrent GBM |
Additional relevant MeSH terms:
Glioblastoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type |
Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Perillyl alcohol Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |