Study of 4-Demethylcholesteryloxycarbonylpenclomedine (DM-CHOC-PEN) in Patients With Advanced Cancer

2014-08-27 03:16:41 | BioPortfolio


DM-CHOC-PEN is a new penclomedine analog that has demonstrated antineoplastic activities in human xenograft intracerebrally implanted tumor mouse models, acceptable preclinical toxicities in mouse, rat and dog models; and no behavioral cognitive impairment/neurotoxicities were noted in mouse and rat models.

The drug is ready for human use as an soy bean oil/lecithin/glycerin water emulsion, the latter which has been documented - chemically and biologically to be stable and safe.

Patients with advanced cancer, involving the central nervous system will be eligible for enrollment providing the required blood and other eligibility requirements are met.


4-Demethylcholesterylpenclomedine(4-DM-CHOC-PEN)is a new penclomedine analog that has demonstrated complete remissions when administrated to mice bearing intracranially implanted human cancer xenografts (glioblastomas and breast cancers) and has acceptable preclinical toxicity profiles - mice, rats and dogs.

The drug will be administered intravenously once every 21 days as an infusion. The starting dose will be 39 mg/M2 (based on 1/10 LD10 observed in mice).

A modified accelerated dosing protocol of Simon, Freidlin, et al will be used to escalate dosage which will reduce the number of patients required and minimize ineffective doses. The protocol will result in one patient cohorts at 40% dosage escalations. When the 1st instance of a dose limiting toxicity (DLT) [grade - 3 or 4 toxicity] is observed, or the 2nd instance of a 1st course grade 2 toxicity of any type is observed, the cohort for that current dose level will be expanded to3-6 patients and escalation will proceed at 33% increments.

If 2 DLTs are noted at any level, further escalation will cease. The dose level at which 2 DLTs are noted will be considered MAD (maximum administered dose). The MTD (maximum tolerated dose) will be the dose level below the MAD. A total of 6 patients will be enrolled at the MTD to give some assurance of safety prior to recommendation for Phase II starting doses.

During the entirety of the study, intra-patient escalation will be allowed. This will occur if the patient experiences are < grade 2 toxicity at the existing dose, if no > grade 2 toxicity was identified at the existing dose and no DLTs were noted at the higher dose level (if any patients had been escalated to that dose).

Continuation of Therapy - Patients who experience stabilization, partial or complete remission while being treated will continue to receive the drug as per the last dose prior to identifying positive results at an every 3 weeks interval.

Discontinuation of therapy - progressive disease and/or toxicities.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Brain Neoplasms




Tulane University Medical School
New Orleans
United States


Not yet recruiting



Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:16:41-0400

Clinical Trials [742 Associated Clinical Trials listed on BioPortfolio]

DM-CHOC-PEN for Brain Tumors in AYA Subjects

4-Demethyl-4-cholesteryloxycarbonylpenclomedine (DM-CHOC-PEN) is a polychlorinated pyridyl cholesterol carbonate that is lipophilic, electrically neural, crosses the blood brain barrier (B...

DM-CHOC-PEN Plus Radiation for Brain Tumors

4-Demethyl-4-cholesteryloxycarbonylpenclomedine (DM-CHOC-PEN) is a polychlorinated pyridyl cholesterol carbonate that is lipophilic, electrically neural, crosses the blood brain barrier (B...

A Phase I Study of DM-CHOC-PEN in Pediatric and Adolescent Subjects With Advanced Cancers

4-Demethyl-4-cholesteryloxycarbonylpenclomedine (DM-CHOC-PEN) is a polychlorinated pyridyl cholesterol carbonate that is lipophilic, electrically neural, crosses the blood brain barrier (B...

Role of MR Spectroscopy in Brain Tumors

In order to come as close as possible to the correct diagnosis of CNS tumors, MRI is the long-standing accepted method of choice that can in some cases be supported by the use of CT to dem...

Evaluation of Anatomy, Clinical and Neuropsychological Long-term Sequelae of Patients Treated With Radiation Therapy for Brain Tumor

Through this study, the investigators believe to describe more accurately the damage caused by brain radiation therapy in the long term.

PubMed Articles [6965 Associated PubMed Articles listed on BioPortfolio]

Evaluation of peritumoral brain parenchyma using contrast-enhanced 3D FIESTA at 3T for differentiating metastatic brain tumors and glioblastomas.

Metastatic brain tumors and glioblastomas are the two of the most common brain neoplasms in adults. However, distinguishing solitary metastatic brain tumors from glioblastomas on conventional magnetic...

Serous Neoplasms of the Pancreas: A Comprehensive Review.

Serous neoplasms are uncommon, usually cystic tumors that account for less than 1% of all primary pancreatic lesions. They consist predominantly of a monomorphic epithelial cell population with a glyc...

Unusual case of intraluminal cecal recurrence of a low grade appendiceal mucinous neoplasm (LAMN)-Case report and brief literature review.

Appendiceal mucinous neoplasms exhibit a wide spectrum of clinical behavior, ranging from neoplasms which are relatively slow-growing but with considerable risk for recurrence and eventual death and t...

Cutaneous Spindle Cell Neoplasms: Pattern-Based Diagnostic Approach.

- Spindle cell neoplasms arising in the skin comprise a heterogeneous group of tumors with divergent lineages. Cutaneous spindle cell neoplasms are relatively common and present surgical pathologists ...

Can Platelet Distribution Width Be Used to Predict the Possibility of Chronic Myeloproliferative Neoplasms?

Platelet distribution width (PDW) and mean platelet volume are markers of platelet activation and have prognostic value in coronary heart diseases, as well as in cancers of solid organs. In this study...

Medical and Biotech [MESH] Definitions

Neoplasms of the intracranial components of the central nervous system, including the cerebral hemispheres, basal ganglia, hypothalamus, thalamus, brain stem, and cerebellum. Brain neoplasms are subdivided into primary (originating from brain tissue) and secondary (i.e., metastatic) forms. Primary neoplasms are subdivided into benign and malignant forms. In general, brain tumors may also be classified by age of onset, histologic type, or presenting location in the brain.

A collective term for precoordinated organ/neoplasm headings locating neoplasms by organ, as BRAIN NEOPLASMS; DUODENAL NEOPLASMS; LIVER NEOPLASMS; etc.

Neoplasms located in the brain ventricles, including the two lateral, the third, and the fourth ventricle. Ventricular tumors may be primary (e.g., CHOROID PLEXUS NEOPLASMS and GLIOMA, SUBEPENDYMAL), metastasize from distant organs, or occur as extensions of locally invasive tumors from adjacent brain structures.

Benign and malignant intra-axial tumors of the MESENCEPHALON; PONS; or MEDULLA OBLONGATA of the BRAIN STEM. Primary and metastatic neoplasms may occur in this location. Clinical features include ATAXIA, cranial neuropathies (see CRANIAL NERVE DISEASES), NAUSEA, hemiparesis (see HEMIPLEGIA), and quadriparesis. Primary brain stem neoplasms are more frequent in children. Histologic subtypes include GLIOMA; HEMANGIOBLASTOMA; GANGLIOGLIOMA; and EPENDYMOMA.

Primary and metastatic (secondary) tumors of the brain located above the tentorium cerebelli, a fold of dura mater separating the CEREBELLUM and BRAIN STEM from the cerebral hemispheres and DIENCEPHALON (i.e., THALAMUS and HYPOTHALAMUS and related structures). In adults, primary neoplasms tend to arise in the supratentorial compartment, whereas in children they occur more frequently in the infratentorial space. Clinical manifestations vary with the location of the lesion, but SEIZURES; APHASIA; HEMIANOPSIA; hemiparesis; and sensory deficits are relatively common features. Metastatic supratentorial neoplasms are frequently multiple at the time of presentation.

More From BioPortfolio on "Study of 4-Demethylcholesteryloxycarbonylpenclomedine (DM-CHOC-PEN) in Patients With Advanced Cancer"

Quick Search


Relevant Topic

Drug Discovery
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...

Searches Linking to this Trial