Trial · NCT00103142

Vaccine Therapy in Treating Patients With Liver or Lung Metastases From Colorectal Cancer

NCT00103142, Phase 2, Completed, Michael Morse, MD; results first posted 2014-04-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Vaccine Therapy in Treating Patients With Liver or Lung Metastases From Colorectal Cancer. Trials, record NCT00103142. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00103142

On this page

Trial

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

Title: Vaccine Therapy in Treating Patients With Liver or Lung Metastases From Colorectal Cancer
NCT number: NCT00103142
Status: Completed
Phases: Phase 2
Enrollment: 74 participants, actual
Lead sponsor: Michael Morse, MD
Conditions: Colorectal Cancer, Metastatic Cancer
Interventions: falimarev, inalimarev, sargramostim, therapeutic autologous dendritic cells
First posted: 2005-02-08
Last updated: 2015-10-14
Results first posted: 2014-04-07

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Recurrence-free Survival at 2 Years	2 years	Recurrence-free survival for randomized patients receiving dendritic cells (DC) loaded with PANVAC or PANVAC plus Granulocyte-macrophage colony-stimulating factor (GM-CSF) measured from the date of metastasectomy, with relapse defined as documented disease recurrence at any site.
Secondary	Positive Immune Response as Measured by (Enzyme-linked Immunosorbent Spot) ELISpot Assay	13 weeks	CEA-Specific Immune Responders by enzyme-linked immunosorbent spot (ELISpot). The ELISPOT assay is considered positive for a subject if the mean number of spots with CEA exceeds the number of spots with control by a magnitude of 10 and the difference between CEA and control is statistically significant at a level of p=0.05 by the t-test.

Source ClinicalTrials.gov

Outcomes2

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Recurrence-free Survival at 2 Years	2 years		participants	NUMBER
SECONDARY	Positive Immune Response as Measured by (Enzyme-linked Immunosorbent Spot) ELISpot Assay	13 weeks		participants	NUMBER

Source ClinicalTrials.gov

Results by group4

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

Outcome	Group	Value	Units
Recurrence-free Survival at 2 Years	PANVAC-V + PANVAC-F + DC	13	participants
Recurrence-free Survival at 2 Years	PANVAC-V + PANVAC-F + GM-CSF	10	participants
Positive Immune Response as Measured by (Enzyme-linked Immunosorbent Spot) ELISpot Assay	PANVAC-V + PANVAC-F + DC	9	participants
Positive Immune Response as Measured by (Enzyme-linked Immunosorbent Spot) ELISpot Assay	PANVAC-V + PANVAC-F + GM-CSF	4	participants

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	PANVAC-V + PANVAC-F + DC	36
Overall Study	STARTED	PANVAC-V + PANVAC-F + GM-CSF	37
Overall Study	COMPLETED	PANVAC-V + PANVAC-F + DC	33
Overall Study	COMPLETED	PANVAC-V + PANVAC-F + GM-CSF	36
Overall Study	NOT COMPLETED	PANVAC-V + PANVAC-F + DC	3
Overall Study	NOT COMPLETED	PANVAC-V + PANVAC-F + GM-CSF	1

Source ClinicalTrials.gov

Adverse events20

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	Hematologic Adverse Events	Blood and lymphatic system disorders	Arm I	8	35	8
other	Hematologic Adverse Events	Blood and lymphatic system disorders	Arm II	8	36	9
other	Cardiac	Cardiac disorders	Arm I	1	35	1
other	Cardiac	Cardiac disorders	Arm II	5	36	5
other	CONSTITUTIONAL SYMPTOMS	General disorders	Arm I	18	35	18
other	CONSTITUTIONAL SYMPTOMS	General disorders	Arm II	13	36	13
other	Skin	Skin and subcutaneous tissue disorders	Arm I	30	35	30
other	Skin	Skin and subcutaneous tissue disorders	Arm II	23	36	23
other	Endocrine	Endocrine disorders	Arm I	1	35	1
other	Endocrine	Endocrine disorders	Arm II	0	36	0

1 to 10 of 20Source ClinicalTrials.gov

See all 20 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm I
Total, all-cause mortality	Arm II
Total, other adverse events	Arm I	35	35
Total, other adverse events	Arm II	35	36
Total, serious adverse events	Arm I	0	35
Total, serious adverse events	Arm II	0	36

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
23657083	DERIVED

Source PubMed

Grants0

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.

None in this release.

Trial comparisons3

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

Comparison	Source
PANVAC-V + PANVAC-F + DC vs PANVAC-V + PANVAC-F + GM-CSF: Positive Immune Response as Measured by (Enzyme-linked Immunosorbent Spot) ELISpot Assay	Trial comparisons
PANVAC-V + PANVAC-F + DC vs PANVAC-V + PANVAC-F + GM-CSF: Recurrence-free Survival at 2 Years	Trial comparisons
Arm I vs Arm II: serious adverse events	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.

For software

Read this trial from software.

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

GET https://conductscience.org/api/trials/v1/NCT00103142

GET https://conductscience.org/api/trials/v1/NCT00103142/registered

API reference For AI assistants