Status:
WITHDRAWN
A Study of Neoadjuvant Photodynamic Immunomodulation for Colon Cancer
Lead Sponsor:
Edward Nelson
Collaborating Sponsors:
University of California, Irvine
National Cancer Institute (NCI)
Conditions:
Colon Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 resp...
Detailed 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 loca...
Eligibility Criteria
Inclusion
- Patients must have a histologically proven diagnosis of colorectal cancer.
- Have clinical stage I, II, or III disease.
- Expected survival must be greater than twelve (12) months.
- A Karnofsky Performance Status (KPS) must be 70 or greater (Appendix I).
- Patients must be \>21 years of age.
- No prior therapy.
- Female patients must not be lactating and must be surgically sterile (via hysterectomy or bilateral tubal ligation), postmenopausal, or using acceptable methods of contraception if they are of child bearing potential. Female patients of childbearing potential must also have a negative serum pregnancy test.
- Patients must be able to understand and sign an informed consent form, which must comply with U.S. regulations (U.S. 21 CFR 50) and ICH guidelines.
- Eligible patients must have adequate initial hematologic and coagulation parameters, hemoglobin ≥ 11g/dl, platelet count \>50,000, Protime and Prothrombin Time ≤ 1.5 x normal.
- Eligible patients must have adequate bone marrow, liver and renal function: ANC \> 1500/μL, Platelets \>100,000 x μL, total bilirubin \< the upper limit of normal (ULN), and creatinine clearance (CrCl) \> 45 mL/min
Exclusion
- Any co-morbidity that precludes primary surgical resection of the colorectal tumor.
- Any significant general organ system compromise including:
- Liver function, transaminases ≥ 2 x,
- Renal function, Cr ≥ 1.5 x upper limit of normal
- Pulmonary function, room air O2 saturation \<90%
- Cardiovascular function, Patients with significant (Class III or IV) cardiovascular disease according to the New York Heart Association's functional criteria (Appendix II)
- Gastrointestinal function, i.e. active inflammatory bowel disease or active peptic ulcer disease.
- Any contraindication to repeat colonoscopy, such as idiosyncratic reactivity to conscious sedation medications.
- Prior treatment for the diagnosis of colorectal cancer, including surgical resection.
- Stage IV colorectal cancer, i.e. the clinical presence of metastases
- Prior malignant diagnosis except for the basal cell epithelioma of the skin.
- Persistent fever greater than 38 C.
- Mineral overload syndromes for Lead, Zinc, Copper or Iron.
- Use of any agent that modulates 5-ALA metabolism and porphyrin synthesis, e.g. St. John's Wort.
- Required use of corticosteroids or immune suppression for any reason including an organ allograft or HIV infection
- Patients with any acute or chronic illness including cardiovascular disease (e.g. history of atrial fibrillation or ventricular arrhythmias) or history of myocardial infarction, autoimmune state, or any psychiatric illness that in the opinion of the Investigators would compromise treatment.
- Use of investigational drugs within 30 days of execution of the informed consent form.
Key Trial Info
Start Date :
August 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01522677
Start Date
August 1 2012
End Date
May 1 2014
Last Update
December 1 2016
Active Locations (2)
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1
University of California, Irvine
Orange, California, United States, 92868
2
Mounst Sinai School of Medicine
New York, New York, United States, 10029