Silicon Phthalocyanine 4 and Photodynamic Therapy in Stage IA-IIA Cutaneous T-Cell Non-Hodgkin Lymphoma
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Purpose
This phase I trial studies the side effects and best dose of silicon phthalocyanine 4 and photodynamic therapy in treating patients with stage IA-IIA cutaneous T-cell non-Hodgkin lymphoma. Photodynamic therapy (PDT) uses a drug, silicon phthalocyanine 4, that becomes active when it is exposed to a certain kind of light. When the drug is active, cancer cells are killed. This may be effective against cutaneous T-cell non-Hodgkin lymphoma
| Condition | Intervention | Phase |
|---|---|---|
|
Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma Recurrent Mycosis Fungoides/Sezary Syndrome Stage I Cutaneous T-cell Non-Hodgkin Lymphoma Stage IA Mycosis Fungoides/Sezary Syndrome Stage IB Mycosis Fungoides/Sezary Syndrome Stage II Cutaneous T-cell Non-Hodgkin Lymphoma Stage IIA Mycosis Fungoides/Sezary Syndrome |
Drug: silicon phthalocyanine 4 Drug: photodynamic therapy Other: pharmacological study Other: laboratory biomarker analysis |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Silicon Phthalocyanine Pc4 for Photodynamic Therapy of Cutaneous T-cell Lymphoma: Single and Repeated Photoexposures |
- MTD 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 [ Time Frame: Up to 30 days ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 24 |
| Study Start Date: | April 2013 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment (silicon phthalocyanine 4 and PDT)
Patients receive silicon phthalocyanine 4 topically and then undergo PDT.
|
Drug: silicon phthalocyanine 4
Given topically
Other Names:
Drug: photodynamic therapy
Undergo DPT
Other Names:
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Other: laboratory biomarker analysis
Correlative studies
|
Detailed Description:
PRIMARY OBJECTIVES:
I. Determine the safety and maximum tolerated dose (MTD) that can be utilized for a single treatment of Pc 4-PDT (silicon phthalocyanine 4 photo dynamic therapy) on subjects with mycosis fungoides (MF)/cutaneous T-cell lymphoma (CTCL) stage IA-IIA, by evaluating an accelerated dose escalation protocol consisting of a single exposure to PDT using topically-applied Pc 4 and visible light at a wavelength of 675 nm, followed by assessment of skin biopsies to analyze cellular and molecular changes induced by Pc 4-PDT. (Cohort I)
II. Determine safety and tolerability of repeated light (PDT) exposures after a single application of Pc 4 to a MF/CTCL plaque, using topically-applied Pc 4 and visible light at a wavelength of 675nm, followed by assessment of skin biopsies to analyze cellular and molecular changes induced by Pc 4-PDT. (Cohort II)
III. Identification of targets for assessment of efficacy to assist in planning for a Phase II study.
OUTLINE: This is a dose-escalation study.
Patients receive silicon phthalocyanine 4 topically and then undergo PDT.
After completion of study treatment, patients are followed up at 24 hours, 1 week, 2 weeks, and 30 days.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosed with early stage MF (CTCL stage IA-IIA)
- Has at least 2 evaluable plaques
- Has been off systemic therapies for at least 4 weeks
- Has been off topical therapies for at least 2 weeks
- Has been off phototherapies for at least 2 weeks
- All skin photo-types will be included
- Subjects must have the ability to understand and the willingness to sign a written informed consent form
- Women of child-bearing potential must agree to utilize a birth control which results in a failure rate of less that 1% per year during the study; accepted forms of birth control for this study include: injections such as Depo-Provera and Lunelle, implants such as Norplant, and intra-uterine devices
- Sexually active males must agree to use a medically acceptable form of birth control for the duration of the study and for at least 3 months after the last dose of the study medication; appropriate birth control methods are using a condom with a spermicide or surgical sterilization
Exclusion Criteria:
- Active history of photosensitivity (e.g. xeroderma pigmentosum, lupus erythematosus, porphyria, severe polymorphous light eruption, solar urticaria)
- Any medical condition that could be aggravated or may cause extreme discomfort during the study period
- Lesions only on the face, scalp or other sites that would make biopsies not cosmetically acceptable
- Women of childbearing potential who are pregnant or attempting to become pregnant are excluded from this study
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to silicon phthalocyanine (Pc 4) or other agents used in this study
- Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Contacts and Locations| United States, Ohio | |
| Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Recruiting |
| Cleveland, Ohio, United States, 44106 | |
| Contact: Elma D. Baron, MD 800-641-2422 elma.baron@case.edu | |
| Principal Investigator: Elma D. Baron | |
| Principal Investigator: | Elma Baron, MD | Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center |
More Information
No publications provided
| Responsible Party: | Kevin Cooper MD, Department Chairman, Dermatology, Case Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01800838 History of Changes |
| Other Study ID Numbers: | CASE2411, NCI-2013-00089 |
| Study First Received: | February 26, 2013 |
| Last Updated: | April 15, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Mycoses Mycosis Fungoides Lymphoma Lymphoma, Non-Hodgkin Sezary Syndrome Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Silicon Phthalocyanine |
Silicon phthalocyanine Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Radiation-Sensitizing Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Therapeutic Uses Antiviral Agents Photosensitizing Agents Dermatologic Agents |
ClinicalTrials.gov processed this record on May 22, 2013