A Study of Neoadjuvant Photodynamic Immunomodulation for Colon Cancer

Status Withdrawn

Clinical Trial Summary

The central hypothesis for this study is that it is safe and feasible to administer intraluminal photodynamic therapy (PDT) to colon cancers by colonoscopy to induce localized inflammatory/immune response. The objective is to demonstrate the feasibility and safety of PDT to colon cancer patients administered before surgery and to characterize the inflammatory/immune response at the tumor site and systemically. The long-term objective of these studies is to modify he natural biology of colorectal cancers and improve patient survival.

Clinical Trial Description

The central hypothesis for this study is that it is safe and feasible to administer intraluminal photodynamic therapy (PDT) to colon cancers, via colonoscopy, in the neoadjuvant setting to induce localized tumor cell death and an inflammatory/immune response with an increased Th1 component, utilizing 5-ALA as a photosensitizer. The objective is to conduct an initial phase I/II clinical study to demonstrate the feasibility and safety of colonoscopic, neoadjuvant intraluminal PDT to colon cancer patients administered 96 hours pre-resection, to characterize the inflammatory/immune response at the PDT treated tumor site, and to evaluate the systemic anti-tumor immune response. The long-term objective of these studies is to provide an easily administered, adjunctive, therapeutic maneuver that lacks systemic toxicity, with the potential to modulate the natural biology of colorectal cancers that have not elicited a favorable anti-tumor immune response and to improve patient survival. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01522677
Study type	Interventional
Source	University of California, Irvine
Contact
Status	Withdrawn
Phase	Phase 1/Phase 2
Start date	August 2012
Completion date	May 2014

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05551052` - CRC Detection Reliable Assessment With Blood
Completed	`NCT03457454` - Reducing Rural Colon Cancer Disparities
Recruiting	`NCT06006390` - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors	Phase 1/Phase 2
Active, not recruiting	`NCT04088955` - A Digimed Oncology PharmacoTherapy Registry
Recruiting	`NCT06010862` - Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors	Phase 1
Terminated	`NCT01347645` - Irinotecan Plus E7820 Versus FOLFIRI in Second-Line Therapy in Patients With Locally Advanced or Metastatic Colon or Rectal Cancer	Phase 1/Phase 2
Completed	`NCT03390907` - Hybrid APC Assisted EMR for Large Colon Polyps	N/A
Recruiting	`NCT03175224` - APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors	Phase 2
Completed	`NCT04079478` - The AID Study: Artificial Intelligence for Colorectal Adenoma Detection
Active, not recruiting	`NCT04057274` - Acute Effect of modeRate-intensity aerOBIc Exercise on Colon Cancer Cell Growth	N/A
Recruiting	`NCT03190941` - Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients	Phase 1/Phase 2
Not yet recruiting	`NCT05147545` - Impact of Exercise and Hyperlipidic Meal on Free Circulating DNA in Patients With Metastatic Colonic Cancer and Healthy Subjects	N/A
Recruiting	`NCT05026268` - The Laparoscopic Right Colectomy With Intracoroporeal Anastomosis	N/A
Not yet recruiting	`NCT03277235` - Effect of a Resilience Model-Based Care Plan in Newly Diagnosed Colorectal Cancer Patients	N/A
Active, not recruiting	`NCT02959541` - PK/PD Investigation of Calciumfolinat in Blood, Tumor and Adjacent Mucosa in Patient With Colon Cancer	N/A
Active, not recruiting	`NCT02730702` - Colon Cancer Risk-stratification Via Optical Analysis of Rectal Ultrastructure
Completed	`NCT02810652` - Perioperative Geriatrics Intervention for Older Cancer Patients Undergoing Surgical Resection	N/A
Recruiting	`NCT02577627` - Multi-Indication, Retrospective Oncological Study to Validate the Accuracy in Predicting TTP by PrediCare in Patients Under SOC	N/A
Terminated	`NCT02628535` - Safety Study of MGD009 in B7-H3-expressing Tumors	Phase 1
Recruiting	`NCT02526836` - Complete Mesocolic Excision With Central Vessel Ligation Compared With Conventional Surgery for Colon Cancer	Phase 2/Phase 3