Trial · NCT00661622

Halt Growth of Liver Tumors From Uveal Melanoma With Closure of Liver Artery Following Injection of GM-CSF

NCT00661622, Phase 2, Completed, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University; results first posted 2015-06-01

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Halt Growth of Liver Tumors From Uveal Melanoma With Closure of Liver Artery Following Injection of GM-CSF. Trials, record NCT00661622. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00661622

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Halt Growth of Liver Tumors From Uveal Melanoma With Closure of Liver Artery Following Injection of GM-CSF
NCT number: NCT00661622
Status: Completed
Phases: Phase 2
Enrollment: 53 participants, actual
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Conditions: Uveal Melanoma, Liver Metastases
Interventions: GM-CSF, Embolization
First posted: 2008-04-18
Last updated: 2025-05-16
Results first posted: 2015-06-01

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Response of Liver Metastases	Every 8 weeks	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)
Primary	Overall Response Rate	Baseline then 3 to 4 weeks after every 2 treatments	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.
Secondary	Overall Survival	Baseline to death	Measured from the start of the treatment to death of patients
Secondary	Median Progression Free Survival	Baseline to time of progression	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).
Secondary	Systemic Progression Free Survival	Baseline to time of progression	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).

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Response of Liver Metastases	Every 8 weeks	participants	NUMBER
PRIMARY	Overall Response Rate	Baseline then 3 to 4 weeks after every 2 treatments	percentage of participants	NUMBER
SECONDARY	Overall Survival	Baseline to death	months	MEDIAN
SECONDARY	Median Progression Free Survival	Baseline to time of progression	months	MEDIAN
SECONDARY	Systemic Progression Free Survival	Baseline to time of progression	months	MEDIAN

Source ClinicalTrials.gov

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Response of Liver Metastases	Immunoembolization	Complete response (CR)	0		participants
Response of Liver Metastases	Plain Embolization	Complete response (CR)	0		participants
Response of Liver Metastases	Immunoembolization	Partial response (PR)	5		participants
Response of Liver Metastases	Plain Embolization	Partial response (PR)	3		participants
Response of Liver Metastases	Immunoembolization	Stable disease (SD)	12		participants
Response of Liver Metastases	Plain Embolization	Stable disease (SD)	19		participants
Response of Liver Metastases	Immunoembolization	Progression (PD)	8		participants
Response of Liver Metastases	Plain Embolization	Progression (PD)	5		participants
Overall Response Rate	Immunoembolization		21.2	90% Confidence Interval 10.3 to 30.5	percentage of participants
Overall Response Rate	Plain Embolization		16.7	90% Confidence Interval 6.3 to 26.9	percentage of participants

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Immunoembolization	26
Overall Study	STARTED	Plain Embolization	27
Overall Study	COMPLETED	Immunoembolization	25
Overall Study	COMPLETED	Plain Embolization	27
Overall Study	NOT COMPLETED	Immunoembolization	1
Overall Study	NOT COMPLETED	Plain Embolization	0

Source ClinicalTrials.gov

Adverse events204

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Agitation	General disorders	Immunoembolization	1	26	1
other	Agitation	General disorders	Plain Embolization	1	27	1
other	Angioedema	Skin and subcutaneous tissue disorders	Immunoembolization	0	26	0
other	Angioedema	Skin and subcutaneous tissue disorders	Plain Embolization	1	27	1
other	Anorexia	General disorders	Immunoembolization	4	26	6
other	Anorexia	General disorders	Plain Embolization	5	27	13
other	Anxiety	Psychiatric disorders	Immunoembolization	2	26	2
other	Anxiety	Psychiatric disorders	Plain Embolization	3	27	5
other	Athritis	Musculoskeletal and connective tissue disorders	Immunoembolization	0	26	0
other	Athritis	Musculoskeletal and connective tissue disorders	Plain Embolization	2	27	3

1 to 10 of 204Source ClinicalTrials.gov

See all 204 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Immunoembolization
Total, all-cause mortality	Plain Embolization
Total, other adverse events	Immunoembolization	26	26
Total, other adverse events	Plain Embolization	23	27
Total, serious adverse events	Immunoembolization	3	26
Total, serious adverse events	Plain Embolization	5	27

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R21CA103250	Immunoembolization of the Hepatic Artery with (GM-CSF)	SATO, TAKAMI	THOMAS JEFFERSON UNIVERSITY	NATIONAL CANCER INSTITUTE	2004 to 2005

Source NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Immunoembolization vs Plain Embolization: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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The record and each of its lists are JSON, twenty rows a page. No key.

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