Colon CancerPhase 1/2NCT01522677
A Study of Neoadjuvant Photodynamic Immunomodulation for Colon Cancer
A Phase 1/2 study testing PDT with 5-ALA radiosensitization in people with Colon Cancer, run by Edward Nelson at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer
- What is being tested?
- PDT with 5-ALA radiosensitization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2012to May 2014
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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)
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mounst Sinai School of Medicine
New York, New York, 10029
University of California, Irvine
Orange, California, 92868
About this study
Official title: A Phase I/II Study of Neoadjuvant Photodynamic Immunomodulation for Colon Cancer
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.
Read the 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 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.
- Conditions
- Colon Cancer
- Being tested
- PDT with 5-ALA radiosensitization
- Keywords
- tumor immunology, neoadjuvant, colonoscopy, photosensitization
- Medical subject headings
- Colonic Neoplasms, Photosensitivity Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PDT with 5-ALA radiosensitizationDrug
Also called Photodynamic therapy, 5-ALA
Patients receive neoadjuvant PDT with radiosensitizing 5-ALA 4 days prior to surgery for colon cancer.
| Study group | Role | What they receive |
|---|---|---|
| PDT | Experimental | Participants receive neoadjuvant 5-ALA and PDT. Receives: Drug: PDT with 5-ALA radiosensitization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
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.
Measured: 6 months
Safety
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.
Measured: 6 months
Secondary outcomes (2)
Quality of Life
Quality of life will be evaluated 6 months following completion of participation in the study
Measured: 6 months after completion of participation
Sustained immunity
Immunologic parameters will be monitored following completion of the study as a measure of sustained immunity
Measured: 1.5-6 months post completion of participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2012 (estimated)
- Study startAug 2012
- Primary completionMay 2014
- Study completionMay 2014
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edward Nelson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Edward Nelson, University of California, Irvine
- Investigators
- Randall F Holcombe, MD, Principal investigator, Icahn School of Medicine at Mount SinaiEdward L Nelson, MD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01522677
- Sponsor's protocol ID
- UCI 10-26
- Other IDs
- 1R21CA153594
- Status last verified
- Nov 2016
- First submitted
- 26 Jan 2012
- Last updated
- 1 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Neoadjuvant Photodynamic Immunomodulation for Colon Cancer
- ClinicalTrials.gov ID
- NCT01522677
- Acronym / sponsor ID
- UCI 10-26
- Conditions
- Colon Cancer
- Keywords
- tumor immunology, neoadjuvant, colonoscopy, photosensitization
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Slow accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Edward NelsonUniversity, hospital or other
- Collaborators
- University of California, Irvine, National Cancer Institute (NCI)
- Study start
- Aug 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 31 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PDT | Experimental | Drug: PDT with 5-ALA radiosensitizationParticipants receive neoadjuvant 5-ALA and PDT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (17 listed)
- Any co-morbidity that precludes primary surgical resection of the colorectal tumor.
- Any significant general organ system compromise including:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PDT with 5-ALA radiosensitizationAlso: Photodynamic therapy, 5-ALAPatients receive neoadjuvant PDT with radiosensitizing 5-ALA 4 days prior to surgery for colon cancer. | Drug | PDT |
Primary outcome
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.
2 secondary outcomes
Quality of Life
Time frame: 6 months after completion of participation
Sustained immunity
Time frame: 1.5-6 months post completion of participation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Randall F Holcombe, MD principal investigator
Icahn School of Medicine at Mount Sinai
Edward L Nelson, MD principal investigator
University of California, Irvine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PDT with 5-ALA radiosensitization in people with Colon Cancer, run by Edward Nelson at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2016.