Clinical trial NCT02256514: Open Label Trial of Immunotherapy for Advanced Liver Cancer
Official title: Open Label Trial of Hepcortespenlisimut-L (V5) Immunotherapy for HCC
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: HCC
Liver Cirrhosis
Keywords: therapeutic vaccine
Lead sponsor: Immunitor LLC
Sponsor class: INDUSTRY
Collaborators: name: Immunitor Inc.
First posted: 2014-10-03
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate daily dosing of oral immunotherapy hepcortespenlisimut-L (V5) in patients with advanced stage of HCC not amenable to surgical intervention or with recurrent tumor after surgery.

Detailed description: Hepcortespenlisimut-L (V5) immunotherapy of HCC in an open label setting with baseline alphafetoprotein serum levels and CT scan image as primary endpoints with monthly follow-up thereafter. Additional endpoints will include blood biochemistry indices and safety monitoring.

Eligibility criteria: Inclusion Criteria:

* Subjects who are at least 18 years old and are willing and capable of providing informed consent. Both men and non-pregnant women will be included.
* HCC diagnosis documented prior to Study Entry by either cytology/histology, CT scan, and AFP serum test higher or equal to 30 IU/ml.
* All subjects with reproductive potential are advised to utilize effective contraception throughout the course of this study.
* Health score status at baseline.
* Agreement to participate in the study and to give at least 3 samples of blood for lab tests.
* Readily available home or o other address where patient can be found.

Exclusion Criteria:

* Subjects who might have already taken V5 in prior trials and have no baseline data.
* Those who met inclusion criteria can be retrospectively enrolled.
* Pregnant or breast-feeding women are excluded.
* Subjects who have taken other immunomodulatory therapies within 2 months prior to Entry: systemic corticosteroids, immune globulin (IV gamma globulin, IVIG), interferons, interleukins, pentoxifylline (Trental), thalidomide, filgrastim (G-CSF), sargramostim (GM-CSF); dinitrochlorobenzene (DNCB), thymosin alpha 1 (thymosin alpha), thymopentin, inosiplex (Isoprinosine), polyribonucleoside (Ampligen), ditiocarb sodium (Imuthiol), any locally available immune modulators, and any other therapeutic or preventive HCC vaccine.
* Subjects requiring concurrent participation in another experimental research treatment study, or who received an experimental agent within four weeks prior to Study Entry.
* Evidence of active or acute cardiac disease, epilepsy, or life-threatening diseases unrelated to HCC.
* Medical conditions such as active alcohol or substance abuse, or psychological issues that in the opinion of the local investigator would interfere with adherence to the requirements of this study.

Primary outcomes:
measure: Effect of hepcortespenlisimut-L (V5) immunotherapy on serum levels of AFP (IU/ml) compared to baseline
timeFrame: minimum 3 months
measure: Effect of hepcortespenlisimut-L (V5) immunotherapy on tumor size or clearance
timeFrame: minimum 3 months
Secondary outcomes:
measure: Effect of hepcortespenlisimut-L (V5) immunotherapy in patients with advanced HCC on blood biochemistry parameters
timeFrame: 3 months
measure: Effect of hepcortespenlisimut-L (V5) immunotherapy on patients' performance
timeFrame: 3 months
Other outcomes:
Locations:
city: Ulaanbaatar
country: Mongolia
facility: Immunitor LLC
Study officials:
affiliation: Immunitor LLC
name: Aldar Bourinbaiar, MD/PhD
role: STUDY_DIRECTOR
References: