DM-CHOC-PEN Plus Radiation for Brain Tumors

NCT03371004 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: DTI-025
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 3

Brief 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) (1). DM-CHOC-PEN has completed Phase I/II trials in humans with primary and secondary tumors involving the brain with success. Complete remissions in both primary astrocytoma and metastatic lung and leukemia malignancies. This trial is open for adult subjects with advanced cancer - brain involvement is required.

Conditions

Advanced Cancer

Keywords

DM-CHOC-PEN; Radiation; Cancer

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  Laboratory and imaging studies to verify responses

  1 year

Secondary Outcomes (1)

• Imaging studies

  6-weeks after treatments

Study Arms (1)

DM-CHOC-PEN + Radiation

EXPERIMENTAL

4-Demethyl-4-cholesteryloxycarbonylpenclomedine (DM-CHOC-PEN) - 39-89.7 MG/M2 iv once and then 3-weeks later radiation - 15-30 Gy will be administered

Drug: 4-Demethyl-4-cholesteryloxycarbonylpenclomedine

Interventions

4-Demethyl-4-cholesteryloxycarbonylpenclomedine DRUG

IV administration as described

Also known as: DM-CHOC-PEN

DM-CHOC-PEN + Radiation

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must have histological proof of a CNS malignancy (primary or metastatic), which has been treated with standard treatments, that may include radiation, and must have measurable lesions.
• 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.

You may not qualify if:

• Subjects must have histological proof of a CNS malignancy (primary or metastatic), which has been treated with standard treatments, that may include radiation, and must have measurable lesions.
• 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.
• 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 incl

Sponsors & Collaborators

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

Study Sites (3)

Tulane University Medical Center

New Orleans, Louisiana, 70112, United States

Location

Tulane University Medical School

New Orleans, Louisiana, 70112, United States

Location

Detroit Clinical Research Centers

Detroit, Michigan, 48336, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Steven DiBiase, MD

  Tulane University Medical Center

  PRINCIPAL INVESTIGATOR

• Lee Roy Morgan, MD, PhD

  DEKK-TEC, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 19, 2017
• First Posted: December 13, 2017
• Study Start: February 5, 2016
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: November 4, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Upon release of the Clinical Trials.gov approval

Locations

US (3)