Safety Study Using Photodynamic Therapy Light Therapy for Patients With Chest Wall Progression of Breast Cancer and Satellite Metastases of Melanoma
CLIPT
A Phase I Trial of Continuous Low-Irradiance Photodynamic Therapy (CLIPT) for Patients Failing Radiation Therapy
2 other identifiers
interventional
48
1 country
1
Brief Summary
This research is intended to explore a new approach to therapy when breast cancer recurs in the skin. The treatment, known as continuous low-irradiance photodynamic therapy, or CLIPT, has shown great promise in animal studies. The investigators goal is to evaluate CLIPT in people, using a novel light delivery system, to assess its side effects and the benefit it has in treating cancer. The investigators goal is to develop a safe, effective therapy that can be given in the doctor's office or possibly at home.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 breast-cancer
Started Jan 2009
Shorter than P25 for phase_1 breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 16, 2009
CompletedFirst Posted
Study publicly available on registry
March 17, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedSeptember 26, 2011
September 1, 2011
2 years
March 16, 2009
September 23, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dose Limiting Toxicity (full thickness ulceration and/or necrosis of the skin)
48 hours to 7 days after treatment
Secondary Outcomes (1)
Efficacy and mechanism of action of CLIPT.
24 hours after treatment
Study Arms (4)
1
EXPERIMENTAL100 J / cm2 over 24 hours
2
EXPERIMENTAL200 J / cm2 over 24 hours
3
EXPERIMENTAL400 J / cm2 over 24 hours
4
EXPERIMENTAL800 J / cm2 over 24 hours
Interventions
A Diomed laser will deliver 630nm (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. Patients will receive a single intravenous injection of Photofrin (0.8mg/kg body weight) 36 - 48 hours prior to the CLIPT procedure. PDT will be delivered over 24 hours for the dose of each arm. Patients will be enrolled in sequential cohorts of six, at increasing laser intensity until the maximum tolerated dose is reached.
Eligibility Criteria
You may qualify if:
- Patients \> 18 years of age, with primary or metastatic cutaneous tumors that have been previously irradiated.
- 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 for Target lesion, and 1 x 1 cm for Control site).
- 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 must sign informed consent.
You may not qualify if:
- 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.
- 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) will be excluded.
- Laboratory values (Note: these are provided by the potential patient):
- Absolute neutrophil count \> 1000.
- Patients with severe hepatic dysfunction (total bilirubin, AST, or ALT \> five times upper limit of normal) will be excluded.
- Adequate coagulation status as indicated by platelet count \> 50,000, PT and PTT \< 1.5 time the upper limit of normal.
- Negative Urine or Serum Pregnancy Test
- Note: No cost to patient, and no compensation provided.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tufts Medical Centerlead
- Susan G. Komen Breast Cancer Foundationcollaborator
- Axcan Pharmacollaborator
Study Sites (1)
Tufts Medical Center
Boston, Massachusetts, 02111, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roger Graham, MD
Tufts Medical Center, Department of Surgery
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2009
First Posted
March 17, 2009
Study Start
January 1, 2009
Primary Completion
January 1, 2011
Study Completion
April 1, 2011
Last Updated
September 26, 2011
Record last verified: 2011-09