Hepatocellular CancerPhase 2NCT02141906
A Pilot Study of "OncozeneTM" Microspheres for Intra-arterial Delivery of Doxorubicin
A Phase 2 study testing Oncozene-DEB-TACE in people with Hepatocellular Cancer, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
This is a pilot study of Onconzene Microspheres for intra-arterial delivery of doxorubicin for the treatement of patients with unresectable hepatocellular cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Cancer
- What is being tested?
- Oncozene-DEB-TACE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2015to 16 May 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have a diagnosis of Hepatocellular carcinoma confirmed by at least one of the following: a) histological confirmation; b) imaging results consistent with cirrhosis and at least one solid liver lesion of >2cm with early enhancement and delayed washout (AASLD criteria for diagnosis of HCC); c) Alpha fetoprotein level >400ng/mL and evidence of at least one solid liver lesion >2cm, regardless of specific imaging characteristics on MRI.
- Tumor not suitable for resection at the time of study entry. (Transplant eligible patients are allowed)
- Age ≥ 18 years.
- Performance status ECOG PS 0-1 (Eastern Cooperative Oncology Group Performance Status).
- Child Pugh Score A only
- Adequate organ and marrow function as defined below:
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- leukocytes ≥ 3,000/mcL (Measurement and Calibration Lab)
- absolute neutrophil count ≥ 1,500/mcL
- platelets ≥ 75,000/mcl
- total bilirubin ≤ 3.0
- AST (Aspartate Aminotransferase)(SGOT)/ALT (Alanine Aminotransferase)(SPGT) ≤ 5 X institutional upper limit of normal
- creatinine ≤ 2.0
- INR (International Normalized Ratio) ≤ 1.8
- Albumin ≥ 2.8
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy
- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
- Absence of occlusive thrombus in the main portal vein
- Life expectancy of at least 6 months
- Ability to understand and the willingness to sign a written informed consent.
Who cannot join
- Chemotherapy or radiotherapy within 4 weeks prior to entering the study or those with residual treatment related toxicity of greater than grade 1 not addressed in inclusion criteria.
- Any concurrent therapy for HCC including concurrent investigational agents.
- Subjects with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to doxorubicin or other agents used in study.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
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- Child-Pugh status B or C
- Encephalopathy no adequately controlled medically
- Known cardiac ejection fraction <50%
- Tumor involving >50% of the liver
- Infiltrative form of HCC on imaging; If there is at least one measurable lesion per mRECIST criteria and otherwise patient is eligible for the study, the patient can be enrolled.
- Extensive extrahepatic spread of hepatocellular carcinoma. Patients with limited metastatic disease may be enrolled as defined as
- lymph node disease
- pulmonary nodules <5 mm in size
- 1-3 bone metastases
- Active gastrointestinal bleeding
- Evidence of uncontrollable bleeding diathesis
- Any contra-indication to angiography
- Any known contra-indication to chemoembolization according to the treating physician
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of "OncozeneTM" Microspheres for Intra-arterial Delivery of Doxorubicin for the Treatment of Patients With Unresectable Hepatocellular Cancer
This is a pilot study of Onconzene Microspheres for intra-arterial delivery of doxorubicin for the treatement of patients with unresectable hepatocellular cancer.
Read the detailed description
The study will evaluate the safety and tolerability of doxorubicin loaded ONCOZENE microspheres chemoemobilization for the treatment of unresectable hepatocellular carcinoma.
The study will also describe the overall response rates of lesions with Oncozene-DEB-TACE(Trans-arterial chemoemobilization) per modified RECIST criteria (Response Evaluation Criteria in Solid Tumors).
Determine progression free survival (PFS) and overall survival (OS) following Oncozene-DEB-TACE (Trans-arterial chemoemobilization)
- Conditions
- Hepatocellular Cancer
- Being tested
- Oncozene-DEB-TACE
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oncozene-DEB-TACEOther
Also called Oncozene microspheres for Doxurubicin delivery
ONCOZENE microspheres are the newly available microspheres for DEB-TACE. It appears (based on the preliminary bench tests) that these microspheres may allow more efficient drug loading, and slow elution and equivalent vascular occlusion(12). In this pilot study, we aim to assess the safety of these microspheres when used for chemoembolization of unresectable hepatocellular carcinoma.
| Study group | Role | What they receive |
|---|---|---|
| Oncozene-DEB-TACE | Experimental | Screening Visit (procedures should be done within 28 days of treatment day):
Study visit assessments will be performed prior to Oncozene-DEB-TACE delivery (except pharmacokinetic blood draw).
Labs may be done within 3 days of the procedure. All visits can be completed +/- 10 days of planned visit day
Follow up after completion of treatment every 4-6 weeks: Receives: Other: Oncozene-DEB-TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response
Treatement response will be measured using modified RECIST assessment for hepatocellular cancer. Patients will undergo a maximum of 3 treatments each, at least 4 weeks apart unless there is a complete response as per mRECIST criteria (no enhancing tumor on subsequent CT or MRI scan)
Measured: (Oncozene-DEB-TACE): TACE 1 Day 22-28, TACE 2-6 Day 22-28, Follow up after completion of treatemtent every 4-6 weeks up to 36 weeks.
Secondary outcomes (1)
Progression
Treated lesion will be evaluated for progression. Progression will be defined according to the mRECIST criteria (Response Evaluation Criteria in Solid Tumors).Patients will undergo a maximum of 3 treatments each, at least 4 weeks apart unless there is a complete response as per mRECIST criteria (no enhancing tumor on subsequent CT or MRI scan)
.
Measured: (Oncozene-DEB-TACE): TACE 1 Day 22-28, TACE 2-6 Day 22-28, Follow up after completion of treatemtent every 4-6 weeks up to 36 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2014 (estimated)
- Study start21 Jan 2015
- Primary completion22 Jun 2018
- Study completion16 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CancerStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Beg, University of Texas Southwestern Medical Center
- Investigators
- Muhammad Beg, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02141906
- Sponsor's protocol ID
- STU 012014-079
- Status last verified
- Aug 2022
- First submitted
- 30 Apr 2014
- Last updated
- 18 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of "OncozeneTM" Microspheres for Intra-arterial Delivery of Doxorubicin for the Treatment of Patients With Unresectable Hepatocellular Cancer
- ClinicalTrials.gov ID
- NCT02141906
- Acronym / sponsor ID
- STU 012014-079
- Conditions
- Hepatocellular Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 21 Jan 2015 (actual)
- Primary completion
- 22 Jun 2018 (actual)
- Study completion
- 16 May 2022 (actual)
- First posted
- 20 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study of Onconzene Microspheres for intra-arterial delivery of doxorubicin for the treatement of patients with unresectable hepatocellular cancer.
Detailed description
The study will evaluate the safety and tolerability of doxorubicin loaded ONCOZENE microspheres chemoemobilization for the treatment of unresectable hepatocellular carcinoma.
The study will also describe the overall response rates of lesions with Oncozene-DEB-TACE(Trans-arterial chemoemobilization) per modified RECIST criteria (Response Evaluation Criteria in Solid Tumors).
Determine progression free survival (PFS) and overall survival (OS) following Oncozene-DEB-TACE (Trans-arterial chemoemobilization)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oncozene-DEB-TACE | Experimental | Other: Oncozene-DEB-TACEScreening Visit (procedures should be done within 28 days of treatment day): Study visit assessments will be performed prior to Oncozene-DEB-TACE delivery (except pharmacokinetic blood draw). Labs may be done within 3 days of the procedure. All visits can be completed +/- 10 days of planned visit day Follow up after completion of treatment every 4-6 weeks: |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Patients must have a diagnosis of Hepatocellular carcinoma confirmed by at least one of the following: a) histological confirmation; b) imaging results consistent with cirrhosis and at least one solid liver lesion of >2cm with early enhancement and delayed washout (AASLD criteria for diagnosis of HCC); c) Alpha fetoprotein level >400ng/mL and evidence of at least one solid liver lesion >2cm, regardless of specific imaging characteristics on MRI.
- Tumor not suitable for resection at the time of study entry. (Transplant eligible patients are allowed)
- Age ≥ 18 years.
- Performance status ECOG PS 0-1 (Eastern Cooperative Oncology Group Performance Status).
- Child Pugh Score A only
Key exclusion criteria (19 listed)
- Chemotherapy or radiotherapy within 4 weeks prior to entering the study or those with residual treatment related toxicity of greater than grade 1 not addressed in inclusion criteria.
- Any concurrent therapy for HCC including concurrent investigational agents.
- Subjects with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to doxorubicin or other agents used in study.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oncozene-DEB-TACEAlso: Oncozene microspheres for Doxurubicin deliveryONCOZENE microspheres are the newly available microspheres for DEB-TACE. It appears (based on the preliminary bench tests) that these microspheres may allow more efficient drug loading, and slow elution and equivalent vascular occlusion(12). In this pilot study, we aim to assess the safety of these microspheres when used for chemoembolization of unresectable hepatocellular carcinoma. | Other | Oncozene-DEB-TACE |
Primary outcome
Response
Time frame: (Oncozene-DEB-TACE): TACE 1 Day 22-28, TACE 2-6 Day 22-28, Follow up after completion of treatemtent every 4-6 weeks up to 36 weeks.
Treatement response will be measured using modified RECIST assessment for hepatocellular cancer. Patients will undergo a maximum of 3 treatments each, at least 4 weeks apart unless there is a complete response as per mRECIST criteria (no enhancing tumor on subsequent CT or MRI scan)
1 secondary outcome
Progression
Time frame: (Oncozene-DEB-TACE): TACE 1 Day 22-28, TACE 2-6 Day 22-28, Follow up after completion of treatemtent every 4-6 weeks up to 36 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Beg, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oncozene-DEB-TACE in people with Hepatocellular Cancer, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response (time frame: (Oncozene-DEB-TACE): TACE 1 Day 22-28, TACE 2-6 Day 22-28, Follow up after completion of treatemtent every 4-6 weeks up to 36 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2022.