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A Study of Neoadjuvant Photodynamic Immunomodulation for Colon Cancer

NCT01522677 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2016-12-01

No results posted yet for this study

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.

Conditions

Interventions

DRUG

PDT with 5-ALA radiosensitization

Patients receive neoadjuvant PDT with radiosensitizing 5-ALA 4 days prior to surgery for colon cancer.

Sponsors & Collaborators

  • University of California, Irvine

    collaborator OTHER

  • National Cancer Institute (NCI)

    collaborator NIH

  • Edward Nelson

    lead OTHER

Principal Investigators

  • Randall F Holcombe, MD · Icahn School of Medicine at Mount Sinai

  • Edward L Nelson, MD · University of California, Irvine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01522677 on ClinicalTrials.gov