A Study of Neoadjuvant Photodynamic Immunomodulation for Colon Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01522677|
Recruitment Status : Withdrawn (Slow accrual)
First Posted : January 31, 2012
Last Update Posted : December 1, 2016
|Condition or disease||Intervention/treatment||Phase|
|Colon Cancer||Drug: PDT with 5-ALA radiosensitization||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Study of Neoadjuvant Photodynamic Immunomodulation for Colon Cancer|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||May 2014|
Participants receive neoadjuvant 5-ALA and PDT.
Drug: PDT with 5-ALA radiosensitization
Patients receive neoadjuvant PDT with radiosensitizing 5-ALA 4 days prior to surgery for colon cancer.
- Efficacy [ Time Frame: 6 months ]Define biologic efficacy of PDT in relation to generation of an immune response at the tumor site and systemically. This will be measured by degree of dendritic cell infiltration into tumor and regional lymph nodes, and degree of systemic immunity directed against colon cancer antigens immediately post procedure and after 6 months.
- Safety [ Time Frame: 6 months ]Safety will be evaluated from enrollment through 6 months. This will be measured by proportion of patients completing planned surgery, proportion of patients experiencing grade 3 or 4 toxicities, and lack of observation of serious adverse events related to the study procedure.
- Quality of Life [ Time Frame: 6 months after completion of participation ]Quality of life will be evaluated 6 months following completion of participation in the study
- Sustained immunity [ Time Frame: 1.5-6 months post completion of participation ]Immunologic parameters will be monitored following completion of the study as a measure of sustained immunity
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01522677
|United States, California|
|University of California, Irvine|
|Orange, California, United States, 92868|
|United States, New York|
|Mounst Sinai School of Medicine|
|New York, New York, United States, 10029|
|Principal Investigator:||Randall F Holcombe, MD||Icahn School of Medicine at Mount Sinai|
|Principal Investigator:||Edward L Nelson, MD||University of California, Irvine|