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Safety and Efficacy Study in Recurrent Grade IV Glioma

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ClinicalTrials.gov Identifier: NCT02704858
Recruitment Status : Recruiting
First Posted : March 10, 2016
Last Update Posted : August 19, 2020
Sponsor:
Collaborator:
ClinDatrix, Inc.
Information provided by (Responsible Party):
Neonc Technologies, Inc.

Brief Summary:
This multi-site, Phase 1/2a clinical trial is an open-label study to identify the safety, pharmacokinetics, and efficacy of a repeated dose regimen of NEO100 (perillyl alcohol) for the treatment of patients with radiographically-confirmed progression of Grade IV glioma or recurrent primary or secondary Grade IV glioma. The study will have two phases, Phase 1 and Phase 2a. Phase 1 is a standard cohort dose escalation 3+3 design used to determine the maximum tolerated dose for Phase 2a. There will be up to 24 patients enrolled in Phase 1. There will be 25 patients enrolled in Phase 2a. For both phases of the study, NEO100 will be self-administered four times daily for a 28-day treatment cycle up to six cycles until disease progression or death, whichever occurs first. At the completion of cycle six, patients will be given the option to continue receiving compassionate use treatment cycles.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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 49 participants
Allocation: N/A
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
Actual Study Start Date : April 8, 2016
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Ethanol

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




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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Laurie Mellott 949-428-6650 laurie.mellott@clindatrix.com
Contact: Audrey DeRamos 949-428-6660 audrey.deramos@clindatrix.com

Locations
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United States, California
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: Anush Arakelyan, MPH, CCRP    323-442-7455    Anush.Arakelyan@med.usc.edu   
Principal Investigator: James Hu, 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   
Principal Investigator: David Peereboom, MD         
United States, Washington
University of Washington Seattle Cancer Care Alliance Recruiting
Seattle, Washington, United States, 98109
Contact: Reba Blissell    206-616-8723    blissr@uw.edu   
Contact: Maianna Dematteis    206-221-0968    mndem@uw.edu   
Principal Investigator: Lynne Taylor, MD         
Sponsors and Collaborators
Neonc Technologies, Inc.
ClinDatrix, Inc.
Investigators
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Study Chair: Tom Chen, MD, PhD NeOnc Technologies
Study Director: Vincent F Simmon, PhD NeOnc Technologies
Study Director: Patrick Walters NeOnc Technologies
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Responsible Party: Neonc Technologies, Inc.
ClinicalTrials.gov Identifier: NCT02704858    
Other Study ID Numbers: NEO100-01
First Posted: March 10, 2016    Key Record Dates
Last Update Posted: August 19, 2020
Last Verified: August 2020
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:
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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