Dexanabinol in Patients With Brain Cancer

NCT01654497 | Completed Phase 1 DMC

• 1 other identifier: 111827
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to try to determine the maximum safe dose of dexanabinol that can be administered to people with brain cancer. Other purposes of this study are to:

• find out what effects (good and bad) dexanabinol has;
• see how much drug gets into the body by collecting blood and cerebrospinal fluid for use in pharmacokinetic (PK) studies;
• learn more about how dexanabinol might affect the growth of cancer cells;
• look at biomarkers (biochemical features that can be used to measure the progress of disease or the effects of a drug).

Conditions

Brain Cancer

Keywords

Brain; Glioma; glioblastoma; metastases; cancer; ETS2101; leptomeningeal; astrocytoma; oligodendroglioma; meningioma

Outcome Measures

Primary Outcomes (1)

• Rate of dose limiting toxicities and the maximum tolerated dose (MTD) of weekly dexanabinol

  first 28 days of treatment

Secondary Outcomes (4)

• Treatment-emergent adverse events

  7 months

• Objective response rate and best overall response rate over time as assessed by the RANO criteria

  approximately 6 months to 1 year

• Progression free survival

  up to 5 years

• Overall Survival

  up to 5 years

Study Arms (1)

Dexanabinol

EXPERIMENTAL

Drug: Dexanabinol

Interventions

Dexanabinol DRUG

Dexanabinol: intravenous infusion over 3 hours, weekly (i.e., Day 1, 8, 15 and 22 of a 28-day cycle) Nine dosing cohorts are planned, with the option to enroll additional cohorts based on safety and PK data. Dose Level 1: 2 mg/kg Dose Level 2: 4 mg/kg Dose Level 3: 8 mg/kg Dose Level 4: 16 mg/kg Dose Level 5: 24 mg/kg Dose Level 6: 28 mg/kg Dose Level 7: 36 mg/kg Dose Level 8: 40 mg/kg Dose Level 9: 44 mg/kg

Dexanabinol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or radiologically confirmed diagnosis of brain cancer:
• glioblastoma (GBM),
• anaplastic astrocytoma (AA),
• anaplastic oligodendroglioma (AO),
• anaplastic mixed oligoastrocytoma (AMO),
• low grade gliomas,
• brain metastases,
• meningiomas, or
• leptomeningeal metastases
• Has failed prior standard therapy including maximal safe surgical resection, radiation therapy (when appropriate for the specific cancer type), and systemic therapy.
• For diagnosis of GBM: has undergone at least one prior surgical gross-total or subtotal tumor resection, a course of postoperative radiation therapy with concurrent temozolomide, and at least 2 cycles of maintenance temozolomide.
• For diagnosis of meningioma: has no other option of standard therapy such as surgical resection (partial or total resection) or radiation.
• Has progression of brain cancer and measurable disease by magnetic resonance imaging (MRI) or computed tomography (CT) scan.
• Age ≥ 18 years.
• Karnofsky Performance Status ≥ 60%. (Appendix A). Subjects must have a life expectancy of equal to or greater than 8 weeks.

You may not qualify if:

• Current or anticipated use of other investigational agents.
• Current or anticipated use of enzyme-inducing anti-epileptic drugs (EIAED).
• Insufficient time for recovery from prior therapy:
• less than 28 days from any investigational agent,
• less than 28 days from prior cytotoxic therapy (except 23 days from prior temozolomide, 14 days from vincristine, 42 days from nitrosoureas, 21 days from procarbazine administration), and
• less than 7 days for non-cytotoxic agents, e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid, etc. (radiosensitizer does not count).
• Less than 4 weeks from surgery or insufficient recovery from surgical-related trauma or wound healing.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to dexanabinol.
• History of allergic reactions to medicines containing polyoxyethylated castor oil that are not controlled with premedications.
• Severe or uncontrolled medical disorder that would, in the investigator's opinion, impair ability to receive study treatment (i.e., uncontrolled diabetes, chronic renal disease, chronic pulmonary disease or active, uncontrolled infection).
• Electrolyte abnormality that cannot be corrected to normal levels prior to initiating study drug.
• Known diagnosis of human immunodeficiency virus (HIV) infection.
• Impaired cardiac function including any of the following:
• Congenital long QT syndrome or a known family history of long QT syndrome;
• History or presence of clinically significant ventricular or atrial tachyarrhythmias

Sponsors & Collaborators

• Santosh Kesari, M.D., Ph.D.: lead
• e-Therapeutics PLC: collaborator

Study Sites (1)

Moores UCSD Cancer Center

La Jolla, California, 92093-0698, United States

Location

MeSH Terms

Conditions

Brain Neoplasms; Glioma; Glioblastoma; Neoplasm Metastasis; Neoplasms; Astrocytoma; Oligodendroglioma; Meningioma

Interventions

HU 211

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Vascular Tissue; Meningeal Neoplasms

Study Officials

• Santosh Kesari, MD, PhD

  University of California Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 16, 2012
• First Posted: July 31, 2012
• Study Start: June 1, 2012
• Primary Completion: September 1, 2015
• Study Completion: July 1, 2017
• Last Updated: November 14, 2019

Record last verified: 2019-11

Locations

US (1)