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Photosensitizer
Photodynamic Therapy Using Silicon Phthalocyanine 4 in Treating Patients With Actinic Keratosis, Bowen's Disease, Skin Cancer, or Stage I or Stage II Mycosis Fungoides
Phase 1
Waitlist Available
Led By Kevin Cooper, MD
Research Sponsored by Case Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. Photodynamic therapy using silicon phthalocyanine 4 may be effective against skin cancer. PURPOSE: This phase I trial is studying the side effects and best dose of photodynamic therapy using silicon phthalocyanine 4 in treating participants with actinic keratosis, Bowen's disease, skin cancer, or stage I or stage II mycosis fungoides.
Eligible Conditions
- Basal cell carcinoma
- Lymphoma
- Precancerous Conditions
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2015 Phase 1 trial • 11 Patients • NCT01800838100%
Pain
18%
pruritus
18%
Itching
18%
Superficial ulceration
18%
Elevated creatinine
9%
Peeling Skin
9%
Cracked Tooth
9%
Hypertension
9%
Palpitations
9%
Nose bleed
9%
Sinusitis
9%
Sinus bradycardia
9%
Dermatitis
9%
excoriation
9%
Sutures Removed
9%
Atrial fibrillation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Silicon Phthalocyanine 4 and PDT)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Topical silicon phthalocyanine 4 (Pc 4) + photodynamic therapyExperimental Treatment1 Intervention
Topical silicon phthalocyanine 4 (Pc 4) followed by photodynamic therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
silicon phthalocyanine 4
2013
Completed Phase 1
~60
Find a Location
Who is running the clinical trial?
Case Comprehensive Cancer CenterLead Sponsor
469 Previous Clinical Trials
33,427 Total Patients Enrolled
42 Trials studying Lymphoma
1,768 Patients Enrolled for Lymphoma
National Cancer Institute (NCI)NIH
13,958 Previous Clinical Trials
41,112,537 Total Patients Enrolled
1,410 Trials studying Lymphoma
383,725 Patients Enrolled for Lymphoma
Kevin Cooper, MDPrincipal InvestigatorCase Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
5 Previous Clinical Trials
165 Total Patients Enrolled
1 Trials studying Lymphoma
22 Patients Enrolled for Lymphoma
Elma Baron, MDPrincipal InvestigatorCase Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
1 Previous Clinical Trials
11 Total Patients Enrolled
1 Trials studying Lymphoma
11 Patients Enrolled for Lymphoma