Trial Outcomes & Findings for Silicon Phthalocyanine 4 and Photodynamic Therapy in Stage IA-IIA Cutaneous T-Cell Non-Hodgkin Lymphoma (NCT NCT01800838)
NCT ID: NCT01800838
Last Updated: 2019-05-16
Results Overview
Defined as the dose immediately below the dose in which 2 or more of 6 patients experience a grade 4 toxicity assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
11 participants
Primary outcome timeframe
Up to 30 days
Results posted on
2019-05-16
Participant Flow
This study recruited patients between April 2013 and April 2015 at Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Participant milestones
| Measure |
Silicon Phthalocyanine 4 (0.1mg/ml) and PDT (50J/cm2)
Level 1: Patients receive 0.1mg/ml silicon phthalocyanine 4 topically and then undergo 50J/cm2 PDT.
silicon phthalocyanine 4: Given topically
photodynamic therapy: Undergo PDT
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
Silicon Phthalocyanine 4 (0.1mg/ml) and PDT (100J/cm2)
Level 2: Patients receive 0.1mg/ml silicon phthalocyanine 4 topically and then undergo 100J/cm2 PDT.
silicon phthalocyanine 4: Given topically
photodynamic therapy: Undergo PDT
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
Pc4 0.1(mg/ml) and Fluence 150(J/cm2)
Level 3: Patients receive 0.1mg/ml silicon phthalocyanine 4 topically and then undergo 150J/cm2 PDT.
silicon phthalocyanine 4: Given topically
photodynamic therapy: Undergo PDT
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
Pc4 0.5(mg/ml) and Fluence 50(J/cm2)
Level 4: Patients receive 0.5mg/ml silicon phthalocyanine 4 topically and then undergo 50J/cm2 PDT.
silicon phthalocyanine 4: Given topically
photodynamic therapy: Undergo PDT
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
7
|
2
|
|
Overall Study
COMPLETED
|
1
|
1
|
7
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Silicon Phthalocyanine 4 and Photodynamic Therapy in Stage IA-IIA Cutaneous T-Cell Non-Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
Silicon Phthalocyanine 4 (0.1mg/ml) and PDT (50 J/cm2)
n=1 Participants
Patients receive 0.1mg/ml silicon phthalocyanine 4 topically and then undergo 50J/cm2 PDT.
silicon phthalocyanine 4: Given topically
photodynamic therapy: Undergo PDT
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
Silicon Phthalocyanine 4 (0.1mg/ml) and PDT (100 J/cm2)
n=1 Participants
Patients receive 0.1mg/ml silicon phthalocyanine 4 topically and then undergo 100J/cm2 PDT.
silicon phthalocyanine 4: Given topically
photodynamic therapy: Undergo PDT
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
Silicon Phthalocyanine 4 (0.1mg/ml) and PDT (150 J/cm2)
n=7 Participants
Patients receive 0.1mg/ml silicon phthalocyanine 4 topically and then undergo 150J/cm2 PDT.
silicon phthalocyanine 4: Given topically
photodynamic therapy: Undergo PDT
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
Silicon Phthalocyanine 4 (0.5mg/ml) and PDT (50 J/cm2)
n=2 Participants
Patients receive 0.5mg/ml silicon phthalocyanine 4 topically and then undergo 50J/cm2 PDT.
silicon phthalocyanine 4: Given topically
photodynamic therapy: Undergo PDT
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
63 years
n=99 Participants
|
61 years
n=107 Participants
|
51 years
n=206 Participants
|
49 years
n=157 Participants
|
55 years
n=390 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
2 Participants
n=390 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
9 Participants
n=390 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
2 Participants
n=157 Participants
|
11 Participants
n=390 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
1 Participants
n=390 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
2 Participants
n=157 Participants
|
10 Participants
n=390 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
7 participants
n=206 Participants
|
2 participants
n=157 Participants
|
11 participants
n=390 Participants
|
|
Fitzpatrick Skin Type Distribution
FST I
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
2 participants
n=206 Participants
|
0 participants
n=157 Participants
|
2 participants
n=390 Participants
|
|
Fitzpatrick Skin Type Distribution
FST II
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
0 participants
n=157 Participants
|
1 participants
n=390 Participants
|
|
Fitzpatrick Skin Type Distribution
FST III
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
1 participants
n=157 Participants
|
6 participants
n=390 Participants
|
|
Fitzpatrick Skin Type Distribution
FST IV
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
1 participants
n=157 Participants
|
2 participants
n=390 Participants
|
|
Fitzpatrick Skin Type Distribution
FST V
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=157 Participants
|
0 participants
n=390 Participants
|
|
Fitzpatrick Skin Type Distribution
FST VI
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=157 Participants
|
0 participants
n=390 Participants
|
PRIMARY outcome
Timeframe: Up to 30 daysDefined as the dose immediately below the dose in which 2 or more of 6 patients experience a grade 4 toxicity assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Outcome measures
| Measure |
Treatment (Silicon Phthalocyanine 4 and PDT)
n=11 Participants
Patients receive silicon phthalocyanine 4 topically and then undergo PDT.
silicon phthalocyanine 4: Given topically
photodynamic therapy: Undergo PDT
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
MTD of Photodynamic Therapy
|
150 J/cm^2
|
PRIMARY outcome
Timeframe: Up to 30 daysOutcome measures
| Measure |
Treatment (Silicon Phthalocyanine 4 and PDT)
n=11 Participants
Patients receive silicon phthalocyanine 4 topically and then undergo PDT.
silicon phthalocyanine 4: Given topically
photodynamic therapy: Undergo PDT
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
MTD of Silicon Phthalocyanine 4 Defined as the Dose Immediately Below the Dose in Which 2 or More of 6 Patients Experience a Grade 4 Toxicity Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
|
0.1 mg/ml
|
Adverse Events
Treatment (Silicon Phthalocyanine 4 and PDT)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment (Silicon Phthalocyanine 4 and PDT)
n=11 participants at risk
Patients receive silicon phthalocyanine 4 topically and then undergo PDT.
silicon phthalocyanine 4: Given topically
photodynamic therapy: Undergo PDT
pharmacological study: Correlative studies
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Skin and subcutaneous tissue disorders
Peeling Skin
|
9.1%
1/11 • Number of events 1 • Patients will be followed for 30 days
|
|
Injury, poisoning and procedural complications
Pain
|
100.0%
11/11 • Number of events 29 • Patients will be followed for 30 days
|
|
Gastrointestinal disorders
Cracked Tooth
|
9.1%
1/11 • Number of events 1 • Patients will be followed for 30 days
|
|
Cardiac disorders
Atrial fibrillation
|
9.1%
1/11 • Number of events 1 • Patients will be followed for 30 days
|
|
Skin and subcutaneous tissue disorders
pruritus
|
18.2%
2/11 • Number of events 2 • Patients will be followed for 30 days
|
|
Injury, poisoning and procedural complications
Sutures Removed
|
9.1%
1/11 • Number of events 1 • Patients will be followed for 30 days
|
|
Skin and subcutaneous tissue disorders
Itching
|
18.2%
2/11 • Number of events 2 • Patients will be followed for 30 days
|
|
Investigations
Elevated creatinine
|
18.2%
2/11 • Number of events 2 • Patients will be followed for 30 days
|
|
Vascular disorders
Hypertension
|
9.1%
1/11 • Number of events 1 • Patients will be followed for 30 days
|
|
Cardiac disorders
Palpitations
|
9.1%
1/11 • Number of events 1 • Patients will be followed for 30 days
|
|
Skin and subcutaneous tissue disorders
Superficial ulceration
|
18.2%
2/11 • Number of events 2 • Patients will be followed for 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Nose bleed
|
9.1%
1/11 • Number of events 1 • Patients will be followed for 30 days
|
|
Infections and infestations
Sinusitis
|
9.1%
1/11 • Number of events 1 • Patients will be followed for 30 days
|
|
Cardiac disorders
Sinus bradycardia
|
9.1%
1/11 • Number of events 1 • Patients will be followed for 30 days
|
|
Injury, poisoning and procedural complications
Dermatitis
|
9.1%
1/11 • Number of events 1 • Patients will be followed for 30 days
|
|
Skin and subcutaneous tissue disorders
excoriation
|
9.1%
1/11 • Number of events 1 • Patients will be followed for 30 days
|
Additional Information
Dr. Elma Baron
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Phone: 216-368-4971
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place