Neoplasms

All Conditions

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Carcinoma

Recurrence

Carcinoma, Basal Cell

Skin Neoplasms

Skin Diseases

Dermatologic Agents

All Drugs and Chemicals

Aminolevulinic Acid

Photosensitizing Agents

aminolevulinic acid hydrochloride

Roy G. Geronemus, MD

Diana Santanello

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. This may be an effective treatment against skin cancer.

PURPOSE: This phase II trial is studying the side effects of photodynamic therapy using aminolevulinic acid and to see how well it works in treating patients with skin cancer.

OBJECTIVES:

* To determine the safety and efficacy of intralesional photodynamic therapy using aminolevulinic acid and non-coherent blue light in patients with nodular basal cell carcinoma.

OUTLINE: Patients undergo photodynamic therapy comprising intralesional injection of aminolevulinic acid followed by non-coherent blue light therapy over approximately 17 minutes. Patients may undergo re-treatment with photodynamic therapy 8 weeks later.

Patients undergo photographic assessment of their skin lesions at baseline, 8 weeks, 16 weeks, and then at 1 and 2 years to evaluate healing time, clinical improvement, and side effects.

Patients undergo biopsies of their skin lesions at 16 weeks and then at 1 and 2 years to confirm histological clearance.

Photodynamic Therapy Using Aminolevulinic Acid in Treating Patients With Skin Cancer

Investigation of the Effectiveness of Non-Coherent Blue Light in Intralesional Photodynamic of Basal Cell Carcinoma

Laser and Skin Surgery Center of New York

Roy G. Geronemus

Infections

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Mycoses

Mycosis Fungoides

Bacterial Infections

Communicable Diseases

Bacterial Infections and Mycoses

Lymphoma

Lymphoma, T-Cell

Lymphoma, T-Cell, Cutaneous

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Patients receive aminolevulinic acid hydrochloride topically and undergo photodynamic therapy on day 1. Treatment repeats every 4 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning at week 24, patients undergo radiation therapy daily for 4 weeks.

Aminolevulinic Acid Hydrochloride

Photodynamic Therapy

Quality-of-Life Assessment

Radiation Therapy

Aaron Mangold

This pilot phase II trial studies how well photodynamic therapy works in treating patients with mycosis fungoides that does not respond to treatment. Photodynamic therapy uses a drug, such as aminolevulinic acid hydrochloride, that becomes active when it is exposed to light. The activated drug may kill cancer cells.

PRIMARY OBJECTIVES:

I. To determine the efficacy of photodynamic therapy (PDT) in refractory tumors and plaques of mycosis fungoides (MF).

SECONDARY OBJECTIVES:

I. To determine the effects of sequential PDT and radiation therapy (RT). II. To determine the side effect profile of PDT in MF.

EXPLORATORY OBJECTIVES:

I. To determine the quality of life during and after treatment.

OUTLINE:

Patients receive aminolevulinic acid hydrochloride topically and undergo photodynamic therapy on day 1. Treatment repeats every 4 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning at week 24, patients undergo radiation therapy daily for 4 weeks.

After completion of study treatment, patients are followed up for up to 8 weeks.

Photodynamic Therapy in Treating Patients With Refractory Mycosis Fungoides

A Pilot Study of Photodynamic Therapy in Refractory Plaques and Tumors of Mycosis Fungoides

Patient-reported symptoms will be described at each time point using the mean, confidence interval, median, and range. Graphical procedures will include stream plots of individual patient scores and plots of average values over time. Correlational analyses will be done to determine the relationships among patients-reported symptoms, as well as with clinical outcomes (response) and clinician-assessed symptoms (National Cancer Institute \[NCI\] CTCAE v4).

Patient-reported symptoms and QOL will be described at each time point using the mean, confidence interval, median, and range. Graphical procedures will include stream plots of individual patient scores and plots of average values over time. Correlational analyses will be done to determine the relationships among patients-reported symptoms and QOL, as well as with clinical outcomes (response) and clinician-assessed symptoms (NCI CTCAE v4).

Will be determined by Composite Assessment of Index Lesion Severity (CAILS) and Physician Global Assessment (PGA).

Will be conducted and summarized using means, standard deviations and 95% confidence intervals. Statistical tests on endpoints (t-test for continuous data; Wilcoxon rank-sum test, Fisher?s exact test, or Chi-square test for ordinal data) will be utilized to determine differences at any particular time point. Graphical displays will be produced, such as mean profile plots or bar charts.

The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. AE incidence and severity as measured by the Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0.

National Cancer Institute (NCI)

Mayo Clinic

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Head and Neck Neoplasms

Nasopharyngeal Carcinoma

Mouth Neoplasms

Precancerous Conditions

Oral Cancer

Laryngeal Cancer

Hypopharyngeal Cancer

Lip and Oral Cavity Cancer

Patients receive oral aminolevulinic acid and then undergo continuous photodynamic therapy 4-6 hours later.

Patients receive aminolevulinic acid as in arm I and then undergo fractionated photodynamic therapy 4-6 hours later.

Patients undergo continuous or fractionated photodynamic therapy.

Peter Ahn, MD

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.

PURPOSE: This randomized phase I trial is studying the side effects and best dose of photodynamic therapy in treating patients with premalignant or early stage head and neck tumors.

OBJECTIVES:

Primary

* To evaluate the toxicities associated with aminolevulinic acid-mediated photodynamic therapy when administered continuously or in fractionated doses in patients with premalignant or early stage head and neck lesions.

Secondary

* To assess the efficacy of this regimen in these patients.

OUTLINE: This is a dose-escalation study of photodynamic therapy. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive oral aminolevulinic acid and then undergo continuous photodynamic therapy 4-6 hours later.
* Arm II: Patients receive aminolevulinic acid as in arm I and then undergo fractionated photodynamic therapy 4-6 hours later.

After completion of study therapy, patients are followed up at 1 month, every 3 months for 2 years, and then annually thereafter.

Photodynamic Therapy in Treating Patients With Premalignant or Early Stage Head and Neck Tumors

Photodynamic Therapy for Premalignant and Early Stage Head and Neck Tumors

Abramson Cancer Center at Penn Medicine

Leukoplakia

Leukoplakia, Oral

Pathological Conditions, Anatomical

Mouth Diseases

Stomatognathic Diseases

Oral Leukoplakia

Patients receive aminolevulinic acid PO 3-4 hours before undergoing photodynamic therapy using pulsed dye laser on day 1.

photodynamic therapy

laboratory biomarker analysis

Wong Stuart

This phase I trial studies the side effects and best dose of photodynamic therapy using aminolevulinic acid in treating patients with oral leukoplakia. Photodynamic therapy uses a drug, such as aminolevulinic acid, that becomes active when it is exposed to a certain kind of light. When the drug is active, abnormal cells are killed. Photodynamic therapy using aminolevulinic acid may be effective against oral leukoplakia.

PRIMARY OBJECTIVES:

I. To determine the toxicity and feasibility of photodynamic therapy using pulsed laser therapy and oral aminolevulinic acid in treating patients with oral leukoplakia.

II. To define the dose-limiting toxicity and maximum tolerated dose of photodynamic therapy using pulsed laser therapy and oral aminolevulinic acid in these patients.

SECONDARY OBJECTIVES:

I. To assess the efficacy of photodynamic therapy using pulsed dye laser and oral aminolevulinic acid by examining clinical response at 1 and 3 months.

II. To determine quantitative histologic response at 3 months. III. To explore the association of response with specific molecular and biologic markers (i.e., DNA ploidy, proliferation using Ki-67, apoptosis using TUNEL, cyclin D1, and p53).

OUTLINE: This is a dose-escalation study of long pulsed dye laser light.

Patients receive aminolevulinic acid\* orally (PO) 3-4 hours before undergoing photodynamic therapy using pulsed dye laser on day 1.

(Note: \*Patients in cohort 1 and a latter cohort \[to be determined during the course of the study\] do not receive aminolevulinic acid before photodynamic therapy.)

Patients undergo biopsies of target lesions and clinically uninvolved mucosa 4-8 weeks before beginning therapy and then at 3 months for biomarker studies (DNA ploidy, p53, Ki-67, cyclin D1, and TUNEL assay). Blood is collected on days 1, 2, 14, 28, and 84 for toxicity assessment.

After completion of study treatment, patients are followed for up to 84 days.

Photodynamic Therapy Using Aminolevulinic Acid in Treating Patients With Oral Leukoplakia

Phase I Study of Photodynamic Therapy Using Pulsed Dye Laser and Oral Aminolevulinic Acid in Patients With Oral Leukoplakia

Keratosis, Actinic

Keratosis

Methyl 5-aminolevulinate

METHYLAMINOLEVULINATE HYDROCHLORIDE (MAL)cream 160mg/g. Intervention: Just one application of the product in the actinic keratosis lesions before the photodynamic therapy

AMINOLEVULINIC ACID HYDROCHLORIDE (ALA) gel 78mg/g. Intervention: Just one application of the product in the actinic keratosis lesions before the photodynamic therapy

This is an intrapatient randomized clinical trial. All patients participating in the trial will receive both, experimental and control treatment, randomization will be used to determine side (right or left for treatment). Three visits will be scheduled. In the first visit epidemiological data will be collected , Actinic Keratoses are counted and drawn in a transparent template and also a photograph of each side. In that first visit treatment the PDT will be also performed, the degree of fluorescence, the pain and the degree of immediate local reaction will be measured.

skin after PDT. In the second visit, to be held at 2 or 3 days, the delayed local reaction degree will be assessed. And in the third visit, held a month of PDT the clinical response and patient satisfaction will be assessed.

METHYLAMINOLEVULINATE HYDROCHLORIDE

AMINOLEVULINIC ACID HYDROCHLORIDE

Federico Nepote

Carlos Serra

Photodynamic therapy technique (PDT) is a conventional technique which is performed applying the product under occlusion lesions, let it incubate for 3 hours and then exposed skin to a light source, usually red.

The conclusions of efficacy, tolerance and satisfaction that today are known about PDT with MAL, but not with ALA, which is a new photosensitizer indicated for Actinic Keratoses. The pharmaceutical form of ALA is a gel, which gives a hypothetical better penetration and consequently it is more effectively.

Intraindividual comparative study, to evaluate efficacy and safety of the treatment of actinic keratosis with photodynamic therapy between methyl aminolevulinate cream (MAL) and aminolevulinic acid nanosoma gel (ALA).

MAL cream: is an antineoplastic agent used as a photosensitizer for photodynamic therapy (PDT). The mode of action of methyl aminolevulinate in PDT was shown in the pharmacodynamic (PD) studies. In the target cells,methyl aminolevulinate was converted to photoactive porphyrins, including protoporphyrinIX (PpIX), which are the active photosensitizers. Upon light activation, the photosensitizers give rise to the production of cytotoxic singlet oxygen species which destroy the target cells.

ALA gel: Following topical application of 5-aminolaevulinic acid, the substance is metabolized to protoporphyrin IX, a photoactive compound which accumulates intracellularly in the treated actinic keratosis lesions. Protoporphyrin IX is activated by illumination with red light of a suitable wavelength and energy. In the presence of oxygen, reactive oxygen species are formed. The latter causes damage of cellular components and eventually destroys the target cells.

Photodynamic therapy technique (PDT) is a conventional technique which is performed applying the product under occlusion lesions, let it incubate for 3 hours and then exposed skin to a light source, usually red.

The conclusions of efficacy, tolerance and satisfaction that today are known about PDT with MAL, but not with ALA, which is a new photosensitizer indicated for QA. The pharmaceutical form of ALA is a gel, which gives a hypothetical better penetration and consequently it is more effectively.

Efficacy and Safety of Treatment of Actinic Keratoses With Photodynamic Therapy Between MAL Cream and ALA Gel

Comparative Intraindividual Study, About the Efficacy and Safety of Treatment of Actinic Keratoses With Photodynamic Therapy Between Acid Methyl Aminolevulinate Cream and Aminolevulinic Gel

The main objective of this study is to compare the MAL with the new BF -200 ALA photosensitizer in terms of local reaction and tolerance for the treatment of actinic keratosis .

First of all, the immediate local reaction to the lighting may include a greater or less erythema, inflammation and edema. It is scored on a scale of 0-10 where 0 is normal skin without local reaction and 10 is a maximum local reaction.

The delayed local reaction is defined by the presence in different degrees of erythema, swelling, edema, pustules and scabs. They are also marked from 0 to 10 where 0 is normal skin without reaction and 10 for local maximum reaction.

On the other hand, tolerance will be measured by the number, frequency and grade of reported adverse events in patients.

To compare the efficacy and characteristics of fluorescence emission between the two photosensitizers.

The efficacy will be assessed by the initial photography and the template transparent. Both of them are measured at the beginning of the study and at the end of the study.

Partial response will be defined if ≥75% of initial response of Actinic Keratosis is solved and complete response (CR) lf 100% of Actinic Keratosis is solved.

Fundación Instituto Valenciano de Oncología

Breast Neoplasms

Breast Diseases

Central Nervous System Depressants

Pharmaceutical Solutions

Anesthetics

Patients in this arm will receive the placebo orally approximately 3 hrs prior to anesthesia followed by standard of care BCS. Fluorescence imaging will be performed on tissue specimens resected prior to completion of standard of care resection. Fluorescence-guided resection will not be performed in patients in this arm.

Patients in this arm will receive PD G 506 A orally approximately 3 hrs prior to anesthesia followed by standard of care BCS. Fluorescence imaging will be performed on tissue specimens resected prior to completion of standard of care resection. Fluorescence imaging performed after SoC BCS is complete will guide the resection of additional tissue.

PD G 506 A for oral solution (aminolevulinic acid \[ALA\] hydrochloride \[HCl\] granules for oral solution) is administered as a single dose (20 mg/kg body weight) approximately 3 hours (min 2 hours, max 4 hours) prior to anesthesia.

Fluorescence imaging camera and associated accessories used to view and capture fluorescence and white light images and videos of the surgical cavity and excised tissue specimens during the surgical procedure.

Eagle V1.2 Imaging System

Oral placebo is administered as a single dose approximately 3 hours (min 2 hours, max 4 hours) prior to anesthesia.

Placebo

Maeve Richmond

Jagapreetha Visweswaran

Jennifer Durand, RN

Melinda Porter, RN

Terry P. Mamounas, MD

Melissa Suarez

Linda Castellanos

Sheldon M. Feldman, MD

Christian Donahoe, RN

Nicole Zaremba, MD

Ralph DaCosta, PhD

Breast conserving surgery (BCS) is performed on patients with breast cancer to resect and completely remove the cancer while conserving as much of the surrounding healthy tissue as possible. Current methods do not allow surgeons to determine the completeness of surgical resection in real-time. This often results in the need for a second surgical procedure, or in some cases more than two surgical procedures in order to have confidence that all cancer has been removed.

This Phase 3 study will evaluate the safety and efficacy of the fluorescent imaging agent PD G 506 A for the real-time visualization of cancer during standard of care breast conserving surgery. PD G 506 A is an investigational drug which is converted in the body into a fluorescent molecule that accumulates in cancer cells. Patients receiving PD G 506 A will undergo standard of care breast conserving surgery followed by fluorescence imaging and removal of any potentially cancerous tissue left behind in the surgical cavity.

Re-operations due to positive margins following breast conserving surgery (BCS) increase poor cosmesis, complications, discomfort, stress, adjuvant delay, medical costs and risk of local recurrence. Reducing positive margin rates can be achieved through optimizing surgical procedures. This study evaluates a new method for surgeons to visualize carcinoma in real-time, both in the surgical cavity and on the margins of excised specimen(s) during the index BCS procedure.

The active ingredient of PD G 506A is aminolevulinic acid hydrochloride (ALA HCl). ALA HCl is a prodrug that is metabolized intracellularly to form the fluorescent molecule protoporphyrin IX (PpIX). The exogenous application of ALA HCl leads to a highly selective accumulation of PpIX in malignant tissues.

This Phase 3, 2-part, single-blind \[pathologist(s)-blinded\] randomized placebo-controlled trial study is designed to evaluate the efficacy and safety of PD G 506 A to aid in the visualization of carcinoma during BCS. The Eagle V1.2 Imaging System will be used in this trial to visualize PpIX fluorescence.

Part A is an open-label training phase of the study to optimize workflow and Part B of the study is randomized and single-blind and will serve as the pivotal portion of the study.

Part A of the study is open-label. All patients in Part A will receive the investigational drug and will undergo standard of care breast conserving surgery (BCS) followed by fluorescence-guided resection. Part B of the study is randomized and placebo controlled; patients will be randomized to receive placebo + standard of care BCS alone or PD G 506 A + SoC BCS followed by fluorescence-guided resection.

In Part B, the participant and pathologist will be blind to treatment arm allocation for the duration of the study. The surgeon will be blind to treatment arm allocation up until the time that standard of care resection is complete. The blind will be broken during the surgical procedure after the surgeon declares standard of care resection complete.

Fluorescence Imaging of Carcinoma During Breast Conserving Surgery

A Prospective Multi-center Clinical Study Evaluating the Use of PD G 506 A and the Eagle V1.2 Imaging System for the Visualization of Carcinoma During Breast Conserving Surgery

Percentage of patients with negative-margins following fluorescence-guided resection (FGR) among patients with positive margins following standard of care (SoC)

Patient-level specificity to identify residual carcinoma

Patient-level sensitivity to identify residual carcinoma

Orientation-level diagnostic performance of PD G 506 A-induced fluorescence to determine the presence or absence of cancer in the surgical cavity as compared to margin histopathology.

Percentage of patients with at least one histopathology-positive margin following SoC who then have ALL histopathology-negative margins following FGR, among all patients imaged.

Patient-level sensitivity, specificity, NPV, PPV of PD G 506 A-induced fluorescence to determine the presence or absence of residual cancer

Patient-level sensitivity, specificity, PPV and NPV to determine the presence or absence of residual cancer in the surgical cavity at the end of FGR (using modified patient-level definitions)

Patient-level sensitivity, specificity, PPV and NPV to determine the presence or absence of cancer in the surgical cavity after SoC BCS.

Patient-level sensitivity, specificity, PPV and NPV to determine the presence or absence of cancer in the surgical cavity after SoC (using modified patient-level definitions).

Percentage of patients assessed as residual tumor negative at the end of FGR who had positive final margins on histopathology

Percentage of patients in whom SOC final margins were carcinoma negative and all FL-driven shave specimens are carcinoma-negative

Percentage of patients with histopathology-negative margins at the end of SoC who have at least one orientation that was both FL-positive and histopathology-positive among (1) patients with histopathology negative final margins after SOC and (2) all patients imaged

Percentage of patients with no fluorescence identified at the end of SoC in whom all final margins after SoC are histopathologically confirmed to be negative for carcinoma.

Patient-level in vivo diagnostic performance of PD G 506 A-induced fluorescence to determine the presence or absence of residual cancer in the surgical cavity at the end of FGR as compared to the final margin histopathology.

Percentage of orientations where in vivo and ex vivo fluorescence assessments are discordant.

Percentage of patients receiving a 2nd surgery on the ipsilateral breast within 1 year of index BCS to remove suspected residual disease.

Percentage of patients receiving an early 2nd surgery (planned or actual) on the ipsilateral breast related to positive final margins.

Weight (mg) of all tissue removed based on SoC and/of FGR

Patient satisfaction with the cosmetic outcome of breast conserving surgery performed based on SoC in combination with PD G 506 A and the Eagle V1.2 Imaging System

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Photodynamic Therapy Using Aminolevulinic Acid in Treating Patients With Skin Cancer	NCT00747903	Non-melanomatou...	aminolevulinic ...	30 Years -	National Cancer Institute (NCI)
Photodynamic Therapy in Treating Patients With Refractory Mycosis Fungoides	NCT03281811	Refractory Myco...	Aminolevulinic ... Photodynamic Th... Quality-of-Life... Radiation Thera...	18 Years -	Mayo Clinic
Photodynamic Therapy in Treating Patients With Refractory Mycosis Fungoides	NCT03281811	Refractory Myco...	Aminolevulinic ... Photodynamic Th... Quality-of-Life... Radiation Thera...	18 Years -	Mayo Clinic
Photodynamic Therapy in Treating Patients With Premalignant or Early Stage Head and Neck Tumors	NCT00978081	Head and Neck C... Precancerous Co...	aminolevulinic ...	18 Years - 120 Years	Abramson Cancer Center at Penn Medicine
Photodynamic Therapy Using Aminolevulinic Acid in Treating Patients With Oral Leukoplakia	NCT00571558	Oral Leukoplaki...	aminolevulinic ... photodynamic th... laboratory biom...	18 Years -	National Cancer Institute (NCI)
Photodynamic Therapy Using Aminolevulinic Acid in Treating Patients With Skin Cancer	NCT00747903	Non-melanomatou...	aminolevulinic ...	30 Years -	National Cancer Institute (NCI)
Efficacy and Safety of Treatment of Actinic Keratoses With Photodynamic Therapy Between MAL Cream and ALA Gel	NCT02647151	Actinic Keratos...	METHYLAMINOLEVU... AMINOLEVULINIC ...	18 Years -	Fundación Instituto Valenciano de Oncología
Fluorescence Imaging of Carcinoma During Breast Conserving Surgery	NCT04815083	Breast Neoplasm... Breast Cancer	Aminolevulinic ... Eagle V1.2 Imag... Placebo	18 Years -	SBI ALApharma Canada, Inc.
Photodynamic Therapy in Treating Patients With Premalignant or Early Stage Head and Neck Tumors	NCT00978081	Head and Neck C... Precancerous Co...	aminolevulinic ...	18 Years - 120 Years	Abramson Cancer Center at Penn Medicine
Photodynamic Therapy Using Aminolevulinic Acid in Treating Patients With Oral Leukoplakia	NCT00571558	Oral Leukoplaki...	aminolevulinic ... photodynamic th... laboratory biom...	18 Years -	National Cancer Institute (NCI)

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