Safety and Efficacy Study in Recurrent Grade IV Glioma

Study Description

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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

Condition or disease	Intervention/treatment	Phase
Glioblastoma Multiforme	Drug: Perillyl alcohol	Phase 1; Phase 2

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.

Study Design

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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

Arms and Interventions

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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	Drug: Perillyl alcohol; Intranasal administration; Other Name: NEO100

Outcome Measures

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Primary Outcome Measures :

1. 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 ]
2. Phase 2 Primary Outcome: Number of Participants Who Are Alive Each Month For 6 Months [ Time Frame: Up to 6 months ]
3. Phase 2 Primary Outcome: Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related To Treatment [ Time Frame: 6 months ]

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Laurie Mellott	949-428-6650	laurie.mellott@clindatrix.com
Contact: Sally Hafez, MD	949-428-6618|	sally.hafez@clindatrix.com

Locations

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

Sponsors and Collaborators

Neonc Technologies, Inc.

ClinDatrix, Inc.

Investigators

Study Chair:	Tom Chen, MD, PhD	NeOnc Technologies
Study Director:	Vincent F Simmon, PhD	NeOnc Technologies
Study Director:	Patrick Walters	NeOnc Technologies

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Neonc Technologies, Inc.
ClinicalTrials.gov Identifier:	NCT02704858 History of Changes
Other Study ID Numbers:	NEO100-01
First Posted:	March 10, 2016
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