DM-CHOC-PEN for Brain Tumors in AYA Subjects

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

4-Demethyl-4-cholesteryloxycarbonylpenclomedine (DM-CHOC-PEN) is a polychlorinated pyridyl cholesterol carbonate that is lipophilic, electrically neural, crosses the blood brain barrier (BBB), ability to localize in intracranial tumor tissue, lacks neurotoxicity and not transported out of the brain via Pgp (p-glycoprotein). DM-CHOC-PEN has completed a Phase I Adolescent and Young Adult (AYA) trial in humans, some of which possessed primary and secondary tumors involving the brain. Complete remissions in both primary (astrocytoma, GBM) and metastatic lung cancers were reported.

This Phase II trial is open for adolescent and young adults (AYA) subjects with advanced cancer - brain involvement is required.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: DEKK-TEC, Inc.

Criteria

Inclusion Criteria: will be as follows -

• Subjects must have histological proof of a malignancy, which has been treated with standard treatments, which may include radiation, and measurable lesions are not required but must have evidence that the disease is advanced.

• Subjects must have life expectancy of at least 12 weeks and a Karnofsky performance score: > 60 % (or a Zubrod performance status of < 2).

• The age limit - a limit of 39 years of age. Gender is not a criterion.

• All subjects must be off previous chemo- and/or radiotherapy for at least three (3) weeks prior to entrance into the study and have recovered from any toxic effects induced by such treatment(s); no nitrosourea type drug or ipilumimab treatments are permitted within the last six (6) weeks prior to enrollment. No major surgery within 14 days of enrollment. Subjects may continue to receive anti- estrogen/steroid therapy that has been initiated at least eight weeks prior to enrollment in the study.

• Subjects should have adequate bone marrow function defined as a peripheral WBC >3,000/mm3 with an ANC >1500/mm3 and a platelet count >100,000/mm3.

• Subjects should have hepatic function (alkaline phosphatase, AST and ALT) < ULN and renal functions with serum creatinine - <1.5 x UNL. If a patient has liver metastasis and/or a history of liver disease - they will receive a lower dose of the drug per treatment protocol.

• Subjects should not be allergic to eggs or soy beans.

• Subjects must be medically, psychologically and neurologically stable and have triplicate baseline ECG's with a mean QTc interval <500 ms and >300 ms and neither a history of congenital prolonged or short QT syndrome. Subjects with a history of cardiac disease must be stable.

• Subjects and/or legal guardian must understand the nature of the study and be willing to sign an informed consent that complies with the investigator/DEKK-TEC policies and approved by the Human Investigation Review Committee.

Exclusion Criteria: will be as follows:

• Subjects with concurrent severe and/or uncontrolled medical co-morbidities - including active infections, unstable uncontrolled diabetes, cardiovascular and pulmonary, renal, psychiatric or social conditions that could compromise the safety or compliance of treatment are not eligible.

• Concomitant chemotherapy or radiotherapy is not permitted.

• Pregnant or lactating females are excluded. Women of childbearing age, and their sexual partners, must use an effective contraception program. Males who are having sexual relations with women capable of child bearing must use the barrier birth control while on the study and for 3-months after the last dose of the study drug.

• Subjects taking CYP3A4 inducers or inhibitors are not eligible since it is not known whether the study drug is metabolized through this pathway. The following CYP3A4 inhibitors/inducers are not permitted during the trial - phenobarbital, fluconazole, erythromycin, verapamil; the latter 3-drugs are moderate CYP3A4 inhibitors.

• Subjects taking the following medications may experience QT/QTc interval prolongation and are not eligible for the trial - most anti-arrhythmia drugs (incl. amiodarone), erythromycin, quinolone antibiotics, ketoconazole, Zithromax, and phenothiazine and will be denied enrollment in the study. The possible interactions of these drugs and DM-CHOC-PEN have not been established. Subjects receiving these drugs will only be eligible if they discontinue the drugs and have an acceptable ECG.

• Coagulopathies - patients requiring full dose anticoagulation with warfarin are excluded. However, patients stable and on other anticoagulants can be included.