Liver Metastases Clinical Trial
Official title:
Immuno-embolization of Hepatic Artery With Granulocyte-macrophage Colony Stimulating Factor (GM-CSF)
Verified date | January 2016 |
Source | Thomas Jefferson University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
Patients with uveal melanoma metastatic to the liver will be treated with embolization of
the hepatic artery every 4 weeks. GM-CSF (granulocyte-macrophage colony simulating factor)
or normal saline will be injected into one of the liver arteries with an oily contrast dye,
Ethiodol. This is followed by blockage of the artery with small pieces of gelatin sponge
(embolization). It is hoped with this novel approach that:
- tumor cells will die due to a loss of their blood supply,
- local inflammatory reactions induced by GM-CSF will kill remaining tumor cells, and
- a systemic immune response against tumor cells may develop.
Status | Completed |
Enrollment | 53 |
Est. completion date | June 2012 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Metastatic uveal melanoma in the liver with histological confirmation - Ability/willingness to give informed consent - ECOG performance status of 0 or 1 - Adequate renal, liver and bone marrow function Exclusion Criteria: - Solitary liver metastasis that is amenable to surgical removal - Presence of symptomatic liver failure including ascites and hepatic encephalopathy - Presence of extra-hepatic metastases - Untreated brain metastases - Uncontrolled hypertension or congestive heart failure or acute myocardial infarction within 6 months of entry - Presence of any other medical complication that imply survival of less than six months - Uncontrolled sever bleeding tendency or active GI bleeding - Significant allergic reaction to contrast dye or GM-CSF - Immunosuppressive treatments such as systemic steroids, radiation to pelvis or systemic chemotherapy within 4 weeks - Previous embolization of the hepatic artery or intrahepatic arterial chemotherapy of liver metastasis - Active hepatitis with serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) greater than 5 x normal - HIV infection positive by ELISA - Pregnancy or breast feeding women - Biliary obstruction, biliary stent or prior biliary surgery except cholecystectomy - Significant arteriovenous shunt identified on angiography of the hepatic artery - Occlusion of main portal vein or inadequate collateral flow around an occluded portal vein |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Thomas Jefferson University | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Response of Liver Metastases | Complete response: Disappearance of all target and non-target liver lesions Partial response: >= 30% decrease in the sum of the longest diameters (LD) relative to baseline sum LD with at least stable non-target liver lesions Stable disease: Absence of change which would qualify as response or progression Progression: >= 20% increase in the sum LD in target liver lesions or unequivocal progression of non-target liver lesions in the treated lobe(s) or appearance of one or more new liver lesions >= 10mm in the treated lobe(s) |
Every 8 weeks | No |
Primary | Overall Response Rate | Clinical response in the liver metastases will be evaluated after every two embolizations using CT scans or MRI of the abdomen. The sum of the longest diameter (LD) of up to 6 target lesions will be used to determine response. Target indicator lesions will be identified and measured as baseline prior to the first embolization. The same target lesions will then be measured 3 to 4 weeks after every two treatments. The sum of the baseline LDs will be compared to the sum of the LDs after every two treatments. | Baseline then 3 to 4 weeks after every 2 treatments | No |
Secondary | Overall Survival | Measured from the start of the treatment to death of patients | Baseline to death | No |
Secondary | Median Progression Free Survival | Measured from the start of the treatment to confirmation of progression of disease by either imaging tests or physical examination. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of one or more new liver lesions >= 10mm in the treated lobe(s). |
Baseline to time of progression | No |
Secondary | Systemic Progression Free Survival | Measured from the start of the treatment to confirmation of progression of disease by either imaging tests or physical examination. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of one or more new liver lesions >= 10mm in the treated lobe(s). |
Baseline to time of progression | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT03781934 -
A Study to Evaluate MIV-818 in Patients With Liver Cancer Manifestations
|
Phase 1/Phase 2 | |
Completed |
NCT02107755 -
Stereotactic Radiation Therapy and Ipilimumab in Treating Patients With Metastatic Melanoma
|
Phase 2 | |
Recruiting |
NCT05057052 -
Cryoablation Combined With Sintilimab Plus Regorafenib In Previously Treated Colorectal Cancer Liver Metastasis
|
Phase 2 | |
Recruiting |
NCT06120127 -
Postoperative Chemotherapy With/Without Radiotherapy and Immunotherapy for Colorectal Liver Metastases With High Risk of Locally Recurrence
|
Phase 2 | |
Recruiting |
NCT04837885 -
Intra-arterial Hepatic (IAH) Infusion of Radiolabelled Somatostatin Analogs in GEP-NET Patients With Dominant Liver Metastases
|
Phase 2 | |
Terminated |
NCT04589884 -
Intraoperative EXamination Using MAChine-learning-based HYperspectral for diagNosis & Autonomous Anatomy Assessment
|
||
Not yet recruiting |
NCT04520737 -
Multimodal Prehabilitation During Chemotherapy in Patients With Colorectal Liver Metastases
|
N/A | |
Terminated |
NCT02465112 -
Metabolic Radiotherapy After Complete Resection of Liver Metastases in Patient With Digestive Neuroendocrine Tumor
|
Phase 3 | |
Completed |
NCT02352259 -
Treatment of Liver Metastases With Electrochemotherapy (ECTJ) Phase II
|
Phase 2 | |
Active, not recruiting |
NCT01763450 -
Bevacizumab Therapy Untreated Unresectable Liver Metastases From Colorectal Cancer
|
Phase 2 | |
Withdrawn |
NCT01631539 -
Chemoembolisation With CPT11 Loaded DC Bead With Cetuximab and 5FU/LV in First Line in Patients With KRAS Wildtype mCRC
|
N/A | |
Recruiting |
NCT01250158 -
Liver-PILP First-in-Man
|
N/A | |
Terminated |
NCT01233544 -
Radiofrequency Ablation Versus Stereotactic Radiotherapy in Colorectal Liver Metastases
|
Phase 3 | |
Completed |
NCT01347333 -
Stereotactic Body Radiotherapy for Liver Tumors
|
N/A | |
Completed |
NCT01683357 -
Prognosis of One-stage Hepatectomy for Bilobar Colorectal Metastases
|
N/A | |
Completed |
NCT00587756 -
Alternative to Two-Stage Hepatectomy
|
N/A | |
Completed |
NCT04942665 -
Low Dose ICG for Biliary Tract and Tumor Imaging
|
Phase 2 | |
Not yet recruiting |
NCT05354674 -
Multimodal Deep Learning Signature for Evaluation of Response to Bevacizumab in Patient With Colorectal Cancer Liver Metastasis
|
||
Recruiting |
NCT04616495 -
Liver Transplantation in Patients With Unresectable Colorectal Liver Metastases
|
||
Not yet recruiting |
NCT04509635 -
Cetuximab Re-challenge for Colorectal Cancer Liver Metastasis
|
Phase 3 |