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

NCT01048008 | Completed Phase 1 DMC

• 2 other identifiers: DTI-0215R43CA132257-02
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

DM-CHOC-PEN is a polychlorinated pyridine cholesteryl carbonate 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 are currently being enrolled and treated with the protocol. Patients with advanced cancer, with or without central nervous system involvement will be eligible for enrollment, providing the required blood and other eligibility requirements are met.

Conditions

Advanced Cancer; Brain Involvement

Keywords

Glioblastoma multiforme; Advanced cancers; Brain Neoplasms, Malignant, Primary; Brain Tumor, Recurrent; Advanced cancer

Outcome Measures

Primary Outcomes (1)

• Document maximum tolerated dose (MTD) & SLT

  Monitor survival

  one year

Secondary Outcomes (1)

• Document a toxicity profile for the drug

  one year

Study Arms (1)

4-DM-CHOC-PEN

EXPERIMENTAL

DM-CHOC-PEN is an intervention and will be dosed @ 39 mg/M2,escalated in 1-patient cohorts at 40% dosage. * At the 1st DLT - expand to 3-6 patient cohorts/dose with escalations at 33% increments. * The MTD will be where 2 DLTs are noted and the study is discontinued.

Drug: DM-CHOC-PEN

Interventions

DM-CHOC-PEN DRUG

DM-CHOC-PEN will be dosed @ 39 mg/M2, escalated in 1-patient cohorts at 40% dosage. At the 1st DLT - expand to 3-6 patient cohorts/dose with escalations at 33% increments. The MTD will be where 2 DLTs are noted and the study is discontinued.

Also known as: 4-Demethylcholesteryloxycarbonylpenclomedine

4-DM-CHOC-PEN

Eligibility Criteria

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

You may qualify if:

• All patients must have histological evidence of a solid malignant tumor (hematological malignancies are excluded) with convincing clinical, radiographic or isotopic evidence of cancer, for which no effective proven treatment exists. CNS associated tumors are preferred, but not required. Patients must sign an informed consent that complies with the investigator/DEKK-TEC policies and approved by a Human Investigation Review Committee.
• All patients must have a projected survival time of at least 12 weeks and a Karnofsky performance score: \>60% (or Zubrod score of \>2).
• All patients 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). Patients who have received a nitrosourea type drug must have had no treatment within the last six weeks.
• Measurable lesions are not required for admittance to the study - but are desirable.
• Age initiated after limitation - 18 years or older. A separate pediatric study is proposed to evaluate tolerance to the drug in children.
• Gender is not a criterion.

You may not qualify if:

• Hematology WBC \<4,000 mm3 Platelets \<100,000 mm3
• Liver Function If bilirubin, AST, and/or ALT are \>ULN
• Renal Function Creatinine \>1.5 mg%
• Cardiovascular Acute myocardial infarction Congestive heart failure - (NYHA criteria for uncontrolled) Clinically significant cardiac arrhythmias - uncontrolled
• 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 birth control while on the study and for 3-months after the last dose of the study drug.
• Allergies to eggs, lecithin or soy products.

Sponsors & Collaborators

• DEKK-TEC, Inc.: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Tulane University Medical School

New Orleans, Louisiana, 70112, United States

Location

MeSH Terms

Conditions

Glioblastoma; Brain Neoplasms

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Marcus L Ware, MD

  Tulane University Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2010
• First Posted: January 13, 2010
• Study Start: September 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: November 1, 2013
• Last Updated: August 4, 2020

Record last verified: 2014-01

Locations

US (1)