NCT00103142 is a Phase 2 clinical trial of falimarev in Colorectal Cancer, sponsored by Michael Morse, MD.

Who is sponsoring NCT00103142?

NCT00103142 is sponsored by Michael Morse, MD.

What drugs are being tested in NCT00103142?

Interventions in NCT00103142: falimarev, inalimarev, sargramostim, therapeutic autologous dendritic cells.

What condition does NCT00103142 study?

NCT00103142 studies Colorectal Cancer, Metastatic Cancer.

Is NCT00103142 still recruiting?

NCT00103142 is currently completed. Last updated 11 October 2015.

Are results published for NCT00103142?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2015-10-11 · How we verify

NCT00103142

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase II Study of Active Immunotherapy With PANVAC or Autologous, Cultured Dendritic Cells Infected With PANVAC After Complete Resection of Hepatic or Pulmonary Metastases of Colorectal Carcinoma

Completed Phase 2 Results posted Last updated 11 October 2015

What this trial tests

Phase 2 trial testing falimarev in Colorectal Cancer in 74 participants. Completed in 1 March 2013.

Timeline

1 February 2005

Primary endpoint
1 June 2009

1 March 2013

Quick facts

Lead sponsor	Michael Morse, MD
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	74
Start date	1 February 2005
Primary completion	1 June 2009
Estimated completion	1 March 2013
Sites	6 locations across United States

Drugs / interventions tested

falimarev — full drug profile →
inalimarev — full drug profile →
sargramostim (SARGRAMOSTIM) — full drug profile →
therapeutic autologous dendritic cells — full drug profile →

Conditions studied

Colorectal Cancer — all drugs for Colorectal Cancer →
Metastatic Cancer — all drugs for Metastatic Cancer →

Sponsor

Michael Morse, MD — full company profile →

Who can join

18 and older, any sex, with Colorectal Cancer or Metastatic Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Recurrence-free Survival at 2 Years
Time frame: 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.

Sponsor's own description

RATIONALE: Vaccines made from a gene-modified virus and a person's white blood cells may make the body build an effective immune response to kill tumor cells. Biological therapies, such as Granulocyte-macrophage colony-stimulating factor (GM-CSF), may stimulate the immune system in different ways and stop tumor cells from growing. Combining different types of biological therapies may kill more tumor cells. PURPOSE: This randomized phase II trial is studying giving vaccine therapy together with dendritic cells to see how well it works compared to giving vaccine therapy together with GM-CSF in treating patients with liver or lung metastases from colorectal cancer removed by surgery.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Colorectal Cancer

Currently open trials in the same condition.

NCT07152821 — Botensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal Adenocarcino · Phase 3 · recruiting
NCT07353645 — KRAS Neoantigen Nanovaccine as Adjuvant Therapy for Colorectal Cancer/Pancreatic Cancer · Phase 1, PHASE2 · recruiting
NCT07432633 — [18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications · Phase 1, PHASE2 · recruiting
NCT07523919 — Functional and Respiratory Determinants of Long-Term Colorectal Cancer Outcomes · recruiting
NCT07529301 — Functional and Respiratory Predictors of Early Postoperative Outcomes · recruiting

Other Michael Morse, MD trials

Trials by the same sponsor.

NCT02687009 — A Study of Niclosamide in Patients With Resectable Colon Cancer · Phase 1 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00103142 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Michael Morse, MD
Last refreshed: 11 October 2015

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00103142.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing