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Perillyl alcohol

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Perillyl Alcohol

Intranasal delivery of NEO100 (perillyl alcohol) four times a day, escalation up to four different doses to determine maximum tolerated dose.

Intranasal delivery of NEO100 (perillyl alcohol) four times a day. Treatment of total of 25 patients at maximum tolerated dose.

Christopher Beardmore

Chloe Richmond

Aida Lozada, MA

Frances Chow, MD

Jennifer Flowers

Diann Mendenhall

Teresa Allison

David Peereboom, MD

Tom Chen, MD, PhD

Vincent F Simmon, PhD

Patrick Walters

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 or patients with progressed or recurrent Grade III 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 (MTD) for Phase 2a. Fifteen (15) patients were enrolled into the Phase I portion of the clinical trial. The MTD for NEO100 was not reached in humans. As a result the NEO100 dose for Cohort 4 (288 mg/dose - 1152 mg/day) was carried into the Phase 2a portion of the clinical trial. Four (4) patients were enrolled into this study prior to implementation of implementation of version 10 of the clinical trial restricting the Phase 2a population to patients with progressive or recurrent primary or secondary Grade IV gliomas expressing IDH1 mutations or progressive or recurrent primary or secondary Grade IV gliomas expressing IDH1 mutations. None of the four (4) patients expressed IDH1 mutations. There will be 28 patients with progressive or recurrent primary or secondary Grade IV gliomas expressing IDH1 mutations or progressive or recurrent primary or secondary Grade IV gliomas expressing IDH1 mutations enrolled in Phase 2a of the clinical trial. Prior to implementing v10 of this protocol, four (4) patients were enrolled. These patients met the inclusion/exclusion criteria for v9 of the protocol and had wild type IDH1 status. For both phases of the study, NEO100 will be self-administered four times daily for a 28-day treatment cycle up to six treatment 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.

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.

Safety and Efficacy Study in Recurrent or Progressive Grade III or IV IDH1 Mutated Glioma

An Open-Label, Phase 1/2A Dose Escalation Study of Safety and Efficacy of NEO100 in Recurrent or Progressive Grade III or Grade IV Gliomas With IDH1 Mutation

Neonc Technologies, Inc.

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

perillyl alcohol

George Thomas Budd, MD

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the recurrence of cancer. The use of perillyl alcohol may be effective in preventing the recurrence of breast cancer.

PURPOSE: Phase I trial to study the effectiveness of perillyl alcohol in preventing the recurrence of breast cancer in women who have been treated with surgery with or without adjuvant therapy.

OBJECTIVES:

* Determine the maximum tolerated dose of perillyl alcohol in women at risk for recurrent breast cancer.
* Determine the toxicity of this drug in these patients.
* Determine the single-dose and multiple-dose pharmacokinetics of this drug in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive oral perillyl alcohol once daily on days 1-28. Treatment continues every 4 weeks for 3 courses.

Cohorts of 6 patients receive escalating doses of perillyl alcohol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience grade 1 toxicity or at least 1 of 6 patients experience grade 2 or greater toxicity.

Patients are followed weekly.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.

Perillyl Alcohol in Preventing Recurrent Breast Cancer in Women Who Have Been Treated With Surgery With or Without Adjuvant Therapy

Multiple-Dose Phase I and Pharmacokinetic Trial of Perillyl Alcohol

National Cancer Institute (NCI)

The Cleveland Clinic

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Androgens

Hormones

George Wilding, MD

RATIONALE: Drugs used in chemotherapy use different way to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of perillyl alcohol in treating patients with metastatic prostate cancer that has not responded to hormone therapy with androgens.

OBJECTIVES: I. Evaluate the clinical effectiveness of oral perillyl alcohol given to patients with androgen independent metastatic prostate cancer. II. Assess the toxicity of this treatment in these patients.

OUTLINE: Patients receive oral perillyl alcohol 4 times a day for 4 weeks. Patients continue treatment in the absence of severe toxicity and disease progression. Patients are followed every 3 months for survival after disease progression.

PROJECTED ACCRUAL: This study will accrue 20-40 patients in approximately 2 years.

Perillyl Alcohol in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy

A Phase II Trial of Perillyl Alcohol (NSC 641066) Administered Daily In Patients With Metastatic Androgen Independent Prostate Cancer

University of Wisconsin, Madison

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Efficacy Study in Recurrent or Progressive Grade III or IV IDH1 Mutated Glioma	NCT02704858	Glioblastoma Mu...	Perillyl alcoho...	18 Years -	Neonc Technologies, Inc.
Perillyl Alcohol in Preventing Recurrent Breast Cancer in Women Who Have Been Treated With Surgery With or Without Adjuvant Therapy	NCT00022425	Breast Cancer	perillyl alcoho...	18 Years -	National Cancer Institute (NCI)
Perillyl Alcohol in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy	NCT00003238	Prostate Cancer	perillyl alcoho...	- 120 Years	University of Wisconsin, Madison
Safety and Efficacy Study in Recurrent or Progressive Grade III or IV IDH1 Mutated Glioma	NCT02704858	Glioblastoma Mu...	Perillyl alcoho...	18 Years -	Neonc Technologies, Inc.
Perillyl Alcohol in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy	NCT00003238	Prostate Cancer	perillyl alcoho...	- 120 Years	University of Wisconsin, Madison

Spots Global Cancer Trial Database for perillyl alcohol