Safety and Efficacy Study in Recurrent Grade IV Glioma
|
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 : August 19, 2020
|
Sponsor:
Neonc Technologies, Inc.
Collaborator:
ClinDatrix, Inc.
Information provided by (Responsible Party):
Neonc Technologies, Inc.
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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 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 |
| 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 :
- 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 ]
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| 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
| Contact: Laurie Mellott | 949-428-6650 | laurie.mellott@clindatrix.com | |
| Contact: Audrey DeRamos | 949-428-6660 | audrey.deramos@clindatrix.com |
Locations
| 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
| 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 |
| 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:
|
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 |