Breast CancerNCT01262716
A Novel Therapy for the Treatment of Chest Wall Progression of Breast Cancer
An observational study of Breast Cancer, run by Rogers Sciences Inc. at 1 site in United States.
Trial summary
This study will assess safety and ergonomics/engineering design of a novel cancer treatment, Continuous Low Irradiance Photodynamic therapy (CLIPT). We will assess the effects on primary and metastatic tumors involving the skin, in particular to improve the functionality, efficiency and wearability of the light… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Aug 2011
- Phase
- Observational
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will consist of 3 female patients. Eligible patients will be recruited from cancer centers in North America specializing in breast cancer. Recruitment has begun with the Hematology/Oncology, Dermatologic Oncology, and Radiation Oncology programs at Tufts Medical Center, Rhode Island Hospital and the teaching hospitals affiliated with Tufts and Brown Universities. All research related activity will only take place at the Tufts Medical Center.
Who may be able to join
- Patients > 18 years of age, with primary or metastatic cutaneous tumors that may or may not have been previously irradiated.
- ECOG performance status < 3.
- Patients must not have received any systemic anti-cancer therapy within 30 days prior to enrolling in this study.
- Patients must not have received radiation therapy to the target site within 60 days of enrolling on this study.
- Skin of target site and control site must be grade 0 or 1 by Common Terminology
- Patients must have a target lesion and normal peri-umbilical skin that can be covered by the fiber-optic mesh used to deliver CLIPT (10 x 10 cm, or 3 x 3).
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- If located on an extremity, the target lesion must not cover more than 50% of the diameter of the extremity at the level at which it is located.
- Absolute neutrophil count > 1000.
- Adequate coagulation status as indicated by platelet count > 50,000, PT and PTT < 1.5 time the upper limit of normal.
- Patients must sign informed consent.
Who cannot join
- Male patients not considered for this study.
- Patients must have a target lesion in a location other than the hands, feet, genitals, or face. Lesions in those locations will be excluded.
- Patients with medical conditions associated with photosensitivity, such as cutaneous porphyria or a collagen vascular disease, or with known allergies to porphyrins will be excluded.
- Pregnant and nursing patients will be excluded. Women of child-bearing potential must have a negative serum or urine pregnancy test prior to enrollment.
- Patients taking medications known to cause photosensitivity (tetracyclines, sulfonamides, phenothiazines, sulfonylurea hypoglycemic agents, thiazide diuretics, griseofulvin, and fluoroquinolones, St. John's wort and amiodarone) will be excluded.
- Patients with severe hepatic dysfunction (total bilirubin, AST, or ALT > five times upper limit of normal) will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
This study will assess safety and ergonomics/engineering design of a novel cancer treatment, Continuous Low Irradiance Photodynamic therapy (CLIPT). We will assess the effects on primary and metastatic tumors involving the skin, in particular to improve the functionality, efficiency and wearability of the light delivery device (LDD) as well as the overall treatment in subjects with chest wall recurrences of breast cancer. An ongoing study (IRB# 8227), sponsored by a Susan G. Komen Breast Cancer Foundation grant, using a 1st generation LDD device has evaluated and determined a dose-limiting toxicity of CLIPT for subjects with chest wall recurrences of breast cancer.
A Diomed laser will be the device used in this study. The Diomed laser will deliver 630 nm (red spectrum) light through a Fiber Optic Patch. The Fiber Optic patch will be compatible with the laser, delivering light to a designated region on the patient's skin.
- Conditions
- Breast Cancer
- Keywords
- Chest wall progression breast cancer, PDT, Photofrin, Photosensitizer
- Medical subject headings
- Breast Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rogers Sciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI), Tufts Medical Center
- Investigators
- Gary S. Rogers, M.D., Study director, Rogers Sciences Inc.Roger A. Graham, M.D., Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01262716
- Sponsor's protocol ID
- 9439
- Other IDs
- R43CA139644-01A1
- Status last verified
- Oct 2011
- First submitted
- 15 Dec 2010
- Last updated
- 25 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Therapy for the Treatment of Chest Wall Progression of Breast Cancer
- ClinicalTrials.gov ID
- NCT01262716
- Acronym / sponsor ID
- 9439
- Conditions
- Breast Cancer
- Keywords
- Chest wall progression breast cancer, PDT, Photofrin, Photosensitizer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- Rogers Sciences Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI), Tufts Medical Center
- Study start
- Dec 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 17 Dec 2010 (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.
This study will assess safety and ergonomics/engineering design of a novel cancer treatment, Continuous Low Irradiance Photodynamic therapy (CLIPT). We will assess the effects on primary and metastatic tumors involving the skin, in particular to improve the functionality, efficiency and wearability of the light delivery device (LDD) as well as the overall treatment in subjects with chest wall recurrences of breast cancer. An ongoing study (IRB# 8227), sponsored by a Susan G. Komen Breast Cancer Foundation grant, using a 1st generation LDD device has evaluated and determined a dose-limiting toxicity of CLIPT for subjects with chest wall recurrences of breast cancer.
A Diomed laser will be the device used in this study. The Diomed laser will deliver 630 nm (red spectrum) light through a Fiber Optic Patch. The Fiber Optic patch will be compatible with the laser, delivering light to a designated region on the patient's skin.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will consist of 3 female patients. Eligible patients will be recruited from cancer centers in North America specializing in breast cancer. Recruitment has begun with the Hematology/Oncology, Dermatologic Oncology, and Radiation Oncology programs at Tufts Medical Center, Rhode Island Hospital and the teaching hospitals affiliated with Tufts and Brown Universities. All research related activity will only take place at the Tufts Medical Center.
Key inclusion criteria (10 listed)
- Patients > 18 years of age, with primary or metastatic cutaneous tumors that may or may not have been previously irradiated.
- ECOG performance status < 3.
- Patients must not have received any systemic anti-cancer therapy within 30 days prior to enrolling in this study.
- Patients must not have received radiation therapy to the target site within 60 days of enrolling on this study.
- Skin of target site and control site must be grade 0 or 1 by Common Terminology
Key exclusion criteria (6 listed)
- Male patients not considered for this study.
- Patients must have a target lesion in a location other than the hands, feet, genitals, or face. Lesions in those locations will be excluded.
- Patients with medical conditions associated with photosensitivity, such as cutaneous porphyria or a collagen vascular disease, or with known allergies to porphyrins will be excluded.
- Pregnant and nursing patients will be excluded. Women of child-bearing potential must have a negative serum or urine pregnancy test prior to enrollment.
- Patients taking medications known to cause photosensitivity (tetracyclines, sulfonamides, phenothiazines, sulfonylurea hypoglycemic agents, thiazide diuretics, griseofulvin, and fluoroquinolones, St. John's wort and amiodarone) will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2011.
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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.
Gary S. Rogers, M.D. study director
Rogers Sciences Inc.
Roger A. Graham, M.D. principal investigator
Tufts Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Rogers Sciences Inc. at 1 site 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 6 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: finished, as of the sponsor's last update on 25 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 25 Oct 2011.