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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

Primary Purpose

Lymphoma, Non-melanomatous Skin Cancer, Precancerous Condition

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
silicon phthalocyanine 4
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring skin cancer, squamous cell carcinoma of the skin, basal cell carcinoma of the skin, recurrent skin cancer, recurrent mycosis fungoides/Sezary syndrome, stage I mycosis fungoides/Sezary syndrome, stage II mycosis fungoides/Sezary syndrome, actinic keratosis, recurrent cutaneous T-cell non-Hodgkin lymphoma, stage I cutaneous T-cell non-Hodgkin lymphoma, stage II cutaneous T-cell non-Hodgkin lymphoma

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed diagnosis of 1 of the following: Actinic keratosis Bowen's disease Squamous cell skin cancer Basal cell skin cancer Clinical stage IA, IB, IIA, or IIB mycosis fungoides Fitzpatrick skin type I-IV PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified Other Not pregnant or nursing Negative pregnancy test Fertile patient must use effective contraception No diabetes mellitus No known hypersensitivity to ethanol or propylene glycol No significant history of photosensitivity, including diagnosis of any of the following: Porphyria Lupus erythematosus Xeroderma pigmentosum Severe polymorphous light eruption Solar urticaria PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No concurrent chemotherapy Endocrine therapy Not specified Radiotherapy More than 2 weeks since prior anticancer radiotherapy No concurrent radiotherapy Surgery Lesions must be healed after prior biopsy Other More than 2 weeks since prior topical, local, or systemic anticancer therapy More than 2 weeks since prior anticancer phototherapy More than 2 weeks since prior photosensitizing medications, including any of the following: Tetracyclines Quinolones Psoralens Hydrochlorothiazide Furosemide Trimethoprim-sulfamethoxazole Griseofulvin Nalidixic acid Amiodarone Phenothiazines High-dose nonsteroidal anti-inflammatory drugs No other concurrent photosensitizing medications No concurrent therapeutic dose of warfarin that may cause excessive bleeding during skin biopsy

Sites / Locations

  • Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Topical silicon phthalocyanine 4 (Pc 4) + photodynamic therapy

Arm Description

Topical silicon phthalocyanine 4 (Pc 4) followed by photodynamic therapy.

Outcomes

Primary Outcome Measures

Maximum tolerated dose
Local toxicity as measured by physical exam and punch biopsy
Treatment efficacy as measured by physical exam and punch biopsy
Systemic photosensitivity as measured by minimum erythema dose (MED) testing

Secondary Outcome Measures

Full Information

First Posted
February 7, 2005
Last Updated
January 17, 2019
Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00103246
Brief Title
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
Official Title
Phase I Clinical Trial Using Topical Silicon Phthalocyanine (Pc 4) Photodynamic Therapy (PDT) for the Treatment of Pre-Malignant and Malignant Skin Conditions
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
OBJECTIVES: Determine the maximum tolerated dose of photodynamic therapy using topically delivered silicon phthalocyanine 4 in participants with actinic keratosis, Bowen's disease, squamous cell or basal cell skin cancer, or stage IA, IB, IIA, or IIB mycosis fungoides. Determine the safety and toxicity of this therapy with emphasis on whether it induces photosensitivity in non-treated sites in these participants . Determine the antitumor mechanism of this therapy, by monitoring tissue changes via clinical, histological, immunohistochemical, and other biochemical markers, in these participants. Determine, preliminarily, the dose of this therapy that results in highest clearing rates in these participants. OUTLINE: This is a dose-escalation study. Participants receive topical silicon phthalocyanine 4 (Pc 4). One hour later, participants undergo photodynamic therapy. Treatment repeats weekly for up to 3 weeks (up to 3 total treatments for the same lesion OR up to 3 lesions treated if multiple lesions are present). Cohorts of 3 participants receive escalating doses of Pc 4 and visible light until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 1 of 3 participants experiences dose-limiting toxicity. Three additional participants are treated at the MTD. After completion of study therapy, participants are followed for up to 2 weeks. PROJECTED ACCRUAL: A total of 16-45 participants will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Non-melanomatous Skin Cancer, Precancerous Condition
Keywords
skin cancer, squamous cell carcinoma of the skin, basal cell carcinoma of the skin, recurrent skin cancer, recurrent mycosis fungoides/Sezary syndrome, stage I mycosis fungoides/Sezary syndrome, stage II mycosis fungoides/Sezary syndrome, actinic keratosis, recurrent cutaneous T-cell non-Hodgkin lymphoma, stage I cutaneous T-cell non-Hodgkin lymphoma, stage II cutaneous T-cell non-Hodgkin lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Topical silicon phthalocyanine 4 (Pc 4) + photodynamic therapy
Arm Type
Experimental
Arm Description
Topical silicon phthalocyanine 4 (Pc 4) followed by photodynamic therapy.
Intervention Type
Drug
Intervention Name(s)
silicon phthalocyanine 4
Other Intervention Name(s)
Pc 4
Intervention Description
Participants receive topical silicon phthalocyanine 4 (Pc 4). One hour later, participants undergo photodynamic therapy. Treatment repeats weekly for up to 3 weeks (up to 3 total treatments for the same lesion OR up to 3 lesions treated if multiple lesions are present).Cohorts of 3 participants receive escalating doses of Pc 4 and visible light until the maximum tolerated dose (MTD) is determined.
Primary Outcome Measure Information:
Title
Maximum tolerated dose
Time Frame
Treatment repeats weekly for up to 3 weeks. Cohorts of 3 participants receive escalating doses of Pc 4 and visible light until the maximum tolerated dose (MTD) is determined.
Title
Local toxicity as measured by physical exam and punch biopsy
Time Frame
at 24 hours and 2 weeks after the start of study treatment
Title
Treatment efficacy as measured by physical exam and punch biopsy
Time Frame
at 24 hours and 2 weeks after the start of study treatment
Title
Systemic photosensitivity as measured by minimum erythema dose (MED) testing
Time Frame
at 2, 24, and 48 hours after completion of photodynamic therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed diagnosis of 1 of the following: Actinic keratosis Bowen's disease Squamous cell skin cancer Basal cell skin cancer Clinical stage IA, IB, IIA, or IIB mycosis fungoides Fitzpatrick skin type I-IV PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified Other Not pregnant or nursing Negative pregnancy test Fertile patient must use effective contraception No diabetes mellitus No known hypersensitivity to ethanol or propylene glycol No significant history of photosensitivity, including diagnosis of any of the following: Porphyria Lupus erythematosus Xeroderma pigmentosum Severe polymorphous light eruption Solar urticaria PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No concurrent chemotherapy Endocrine therapy Not specified Radiotherapy More than 2 weeks since prior anticancer radiotherapy No concurrent radiotherapy Surgery Lesions must be healed after prior biopsy Other More than 2 weeks since prior topical, local, or systemic anticancer therapy More than 2 weeks since prior anticancer phototherapy More than 2 weeks since prior photosensitizing medications, including any of the following: Tetracyclines Quinolones Psoralens Hydrochlorothiazide Furosemide Trimethoprim-sulfamethoxazole Griseofulvin Nalidixic acid Amiodarone Phenothiazines High-dose nonsteroidal anti-inflammatory drugs No other concurrent photosensitizing medications No concurrent therapeutic dose of warfarin that may cause excessive bleeding during skin biopsy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Cooper, MD
Organizational Affiliation
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elma Baron, MD
Organizational Affiliation
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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