Status:
COMPLETED
DM-CHOC-PEN Plus Radiation for Brain Tumors
Lead Sponsor:
DEKK-TEC, Inc.
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Advanced Cancer
Eligibility:
All Genders
21+ years
Phase:
PHASE1
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...
Detailed Description
The primary goal of this Phase I oncology clinical trial will be to evaluate the safety and use of 4-demethyl-4-cholesteryloxycarbonylpenclomedine (DM-CHOC-PEN) plus radiation, as anticancer therapy f...
Eligibility Criteria
Inclusion
- : Inclusion Criteria will be as follows -
- 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.
Exclusion
- Criteria: Inclusion Criteria: Inclusion Criteria will be as follows -
- 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.
Key Trial Info
Start Date :
February 5 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2022
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT03371004
Start Date
February 5 2016
End Date
October 1 2022
Last Update
November 4 2022
Active Locations (3)
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1
Tulane University Medical Center
New Orleans, Louisiana, United States, 70112
2
Tulane University Medical School
New Orleans, Louisiana, United States, 70112
3
Detroit Clinical Research Centers
Detroit, Michigan, United States, 48336