Dexanabinol in Patients With Brain Cancer

Completed · Phase 1

Conditions studied: Brain Cancer

In brief

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).

Key facts

Study ID

NCT01654497

Run by

Santosh Kesari, M.D., Ph.D.

People needed

26

Starts

2012-06-01

Expected to finish

2017-07-01

Last updated by the study team

2019-11-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• Organ and Marrow Function Requirements
• Hematology:
• Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L
• Platelet count ≥ 100 x 109/L
• Hemoglobin ≥ 9.0 g/dL
• White blood cell (WBC) count ≥ 3.0 x 109/L
• Biochemistry:
• AST/SGOT and ALT/SGPT ≤ 2.5 x institution's ULN
• Total bilirubin ≤ 1.5 x institution's ULN
• Serum creatinine ≤ 1.5 x institution's ULN or 24-hour creatinine clearance ≥ 50 ml/min

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
• Clinically significant resting bradycardia (< 50 beats per minute)
• Inability to monitor the QT interval by ECG
• QTc > 450 msec on baseline ECG. If QTc > 450 and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient re-screened for QTc
• Myocardial infarction within 1 year of starting study drug
• Other clinically significant heart disease (e.g., unstable angina, congestive heart failure, or uncontrolled hypertension)
• Pregnant or nursing. There is a potential for congenital abnormalities and for this regimen to harm nursing infants.

Where it is running

• Moores UCSD Cancer Center — La Jolla, California, United States

Full record on ClinicalTrials.gov

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