Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Carcinoma

Carcinoma in Situ

Anus Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Anal Cancer

Micronutrients

All Drugs and Chemicals

Bone Density Conservation Agents

Dermatologic Agents

Vitamins

Vitamin D

Cholecalciferol

Aminolevulinic Acid

Photosensitizing Agents

Ergocalciferols

Trace Elements

Hormones

Calcium

Calcium, Dietary

Vitamin D3

Calciferol

Ergocalciferol

Vitamin D2

5-aminolevulinic acid hydrochloride (Gliolan), orally, 40 mg/kg administered approximately 4-6 hours before light administration. There will be two levels of light dose: 50 and 100 J/cm2. Vitamin D3 (cholecalciferol) supplementation (10,000 IU daily) will be provided from 3 days prior through 14 weeks after light delivery for PDT.

Total duration of drug product administration (including any open-label lead-in, if applicable).

Vitamin D3 (cholecalciferol) supplementation (10,000 IU daily) will be provided from 3 days prior through 14 weeks after light delivery for PDT.

None This is a phase I dose escalation study, with two levels of light dose. The design is cohorts of 3s. Light at 50 Joules and Light at 100 joules There are pre-defined DLTs.

5-aminolevulinic acid hydrochloride (Gliolan), orally, 40 mg/kg administered approximately 4-6 hours before light administration. There will be two levels of light dose: 50 and 100 J/cm2. Vitamin D3 (cholecalciferol) supplementation (10,000 IU daily) will be provided from 3 days prior through 14 weeks after light delivery for PDT Total duration of drug product administration (including any open-label lead-in, if applicable).

Vitamin D3 (cholecalciferol) supplementation (10,000 IU daily) will be provided from 3 days prior through 14 weeks after light delivery for PDT.

None This is a phase I dose escalation study, with two levels of light dose. The design is cohorts of 3s. Light at 50 Joules and Light at 100 joules There are pre-defined DLTs.

orally, 40 mg/kg 4-6 hours prior to light application

Gliolan

Vitamin D3 (cholecalciferol) supplementation (10,000 IU daily) will be provided from 3 days prior through 14 weeks after light delivery for PDT.

Vitamin D3 cholecalciferol)

Approximately 4-6 hours after photosensitizer administration, activating light will be applied.

The target mucosal lesion will be identified based on the initial clinical evaluation. Treatment light will be generated using a Modulight ML7710-630-6K diode laser, This laser produces up to 6W total power, with a peak wavelength of 630nm and 90% of laser power within 630-633 nm.

The light fluence (doses) will be 50 and 100 Joules per square centimeter.

Photodynamic Therpay

Keith Cengel, MD, PhD

This is a phase I dose escalation study of photodynamic therapy (PDT) for the treatment of patients with pre-malignant tumors and superficial microinvasive disease of the anal canal and/or perianal skin. All subjects (a maximum of 12) will be given the photosensitizer ALA orally followed by the administration of red light (629-635 nm) to the tumor from a laser. The dose of ALA will be 40 mg/kg administered approximately 4-6 hours before light administration. There will be two levels of light dose: 50 and 100 J/cm2, 3-6 patients in each. Vitamin D3 (cholecalciferol) supplementation (10,000 IU daily) will be provided from 3 days prior through 14 weeks after light delivery for PDT. Patients will be observed for 30 days for the development of DLT. Patients will be followed up for 24 months for additional toxicity and efficacy data collection.

PDT Plus Vitamin D3 for Anal Dysplasia

A Phase I Study of Photodynamic Therapy (PDT) Plus Vitamin D3 for High-grade Anal Dysplasia and Microinvasive Anal Cancer

Abramson Cancer Center at Penn Medicine

Glioblastoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Neuroepithelioma

Amino Acids

Alanine

Single arm : per-operative PhotoDynamic Therapy (perPDT) during the surgery of Glioblastoma excision.

The protocol requires the realization of specific procedures in addition to the usual care.

The per-operative photodynamic therapy ("perPDT") added to surgery for glioblastoma excision. The patient will receive 5-ALA (5- alanine ,GLIOLAN drinkable) 4h before surgery + lighting of the tumor bed by a light source (laser) at the end of resection (Prolonged surgery of 45 minutes).

"perPDT"

patient will receive 5-ALA (5- alanine ,GLIOLAN drinkable) 4h before surgery

GLIOLAN

Nicolas Reyns, MD, PhD

The study pilot evaluate the feasibility of a "5-ALA- PpIX (protoporhyrin IX) mediated per-PDT protocol" in patients with glioblastoma accessible for complete surgical removal of contrast. This treatment will be carried out in addition to the current reference treatment of glioblastoma: maximum resection surgery followed by radiochemotherapy according to the protocol Stupp

INtraoperative photoDYnamic Therapy of GliOblastoma

A Pilot Study of the Feasibility of Intraoperative Photodynamic Therapy of Glioblastoma.

In particular, the following complications will be investigated: severe infection, new neurological deficit responsible for severe disability, status epilepticus, deaths during the postoperative period.

Target: At least 6/10 patients who benefited of complete "PerPDT" and without unacceptable and unexpected toxicities

Determined according to international RANO criteria

Collection of all Adverse events (AEs and SAEs) (according to NCI-CTC V4.0) and reviewing by an Independent Safety Monitoring Board.

The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items.

Measuring the health-related quality of life in patients with brain cancer

Institut National de la Santé Et de la Recherche Médicale, France

University Hospital, Lille

Nervous System Diseases

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

This study is planned to detect a dose-efficacy relationship between the chosen dose levels of MC506/1 and the extent and quality of fluorescence in the tumour core in patients with newly diagnosed malignant glioma.

Clinical Study on 5-aminolevulinic Acid Hydrochloride (5-ALA) for Fluorescence-guided Resection of Malignant Gliomas

Clinical Phase I/II Study on 5-aminolevulinic Acid Hydrochloride (5-ALA) for Fluorescence-guided Resection of Malignant Gliomas

After completion of resection, global fluorescence extent in the tumour core will be assessed by the first and second surgeon. It will be estimated whether approx. 0/3, 1/3, 2/3 or 3/3 of the tumour core is identified using standard white operation light were fluorescent (irrespective of fluorescence quality). The global quality of Gliolan induced tissue fluorescence within the tumour core will be recorded as being strong, weak or missing. As an objective control of the subjective assessment of the fluorescent quality, selected areas will be measured spectrometrically.

medac GmbH

Symptoms and General Pathology

Recurrence

Disease Attributes

All patients will be treated with RDT. Patients are devided into cohorts which differs in the total amount and frequence of RDT.

A repetitive dose of Gliolan will be administrated in combination with radiotherapy (radiodynamic therapy)

Radiotherapy will be performed in combination with Gliolan administration

Radiodynamic therapy

Walter Stummer, Prof. Dr.

Hans Theodor Eich, Prof. Dr.

The investigational drug 5-ALA (known under the trade name Gliolan®) is an approved drug for the surgical removal of malignant glioma (WHO grade III and IV). In this trial, the drug is being tested outside of its actual approval as a radiosensitizer in combination with conventional radiotherapy for first-time recurrence (relapse) of malignant glioma. In this clinical trial, the investigational drug 5-ALA is being used for the first time in a multiple dose escalation regimen in combination with radiotherapy following surgical removal of a recurrent malignant glioma in humans. The investigational drug, 5-ALA, has been used as a single dose to date as a standard of care for visualization of malignant tissue in the surgical removal of gliomas.

The planned clinical trial will first and foremost investigate how well repeated administration of the investigational drug 5-ALA is tolerated in combination with radiotherapy. At the same time, the design of the trial serves to optimize this novel therapeutic procedure with regard to the frequency of administration of the investigational drug 5-ALA in combination with radiotherapy for future clinical trials.

As a secondary objective, the efficacy of additional 5-ALA administration will also be investigated.

A modified 3+3 design is used. The maximum tolerated dose of repeated RDT (consisting of 5-ALA dosing an radiotherapy) and safety will be determined in 9 cohorts.

Radiodynamic Therapy (RDT) With Gliolan in Patients With First Recurrence of Brain Tumor

Phase I/II Dose Escalation Trial of Radiodynamic Therapy (RDT) With 5-Aminolevulinic Acid in Patients With First Recurrence of Glioblastoma

Analytic results for concentration changes as one combined sum parameter

Analytic results for concentration changes

In the resent study we will investigate the maximum-tolerated dose (MTD) of the combination of 5-ALA and radiation. MTD is defined as the highest number of RDT that does not cause unacceptable side effects, i.e. at which no more than 1 of 6 patients suffers a dose-limiting toxicity (DLT). DLT describes side effects of a drug that are serious enough to prevent an increase of dose (NCI dictionary of cancer terms). In the present study it is defined as any ≥ Gr.3 hematological toxicity, any ≥ Gr.3 neurological toxicity and any ≥ Gr.3 non-hematological toxicity occurring during the 6 week observation period, that does not resolve to pre-treatment baseline or ≤ Gr. 2 within 3 weeks, either spontaneously or with adequate treatment.

To detect any relevant DLT the following aspects are monitored:

* Toxicological safety of repeat doses of 5-ALA
* Neurological safety of RDT
* Dermatological safety of RDT
* Assess all new AEs CTCAE grade 2 or higher

Percentage of patients who are alive 6 months after first R(D)T

Percentage of patients without tumor progression 6 months after first R(D)T in adjuvant phase

Percentage of patients without suffering any disease related event such as DLT or progression until 6 months after inclusion

analytic results of pharma-radio-dynamic tissue changes. Tissue samples collected during surgery of cohort 0 and 1

photonamic GmbH & Co. KG

Universität Münster

patient will receive 5-ALA 4 to 6 hours before surgery

The protocol requires the realization of specific procedures in addition to the usual care.

The intra-operative photodynamic therapy ("intraoperative PDT") added to surgery for glioblastoma excision. The patient will receive 5-ALA ( 5-aminolevulinic acid hydrochloride),GLIOLAN drinkable 6h before surgery + lighting of the tumor bed by a red light source (laser with different J/cm²) at the end of resection (Prolonged surgery of 45 minutes).

Intraoperative PDT

Nicolas Reyns, MD,PhD

Maximilien Vermandel, MD

Florence Lefranc, MD

The phase II study evaluate a light dose escalation in a classical intraoperative PDT regimen mediated by 5-ALA-PpIX, in glioblastoma patients with access to full surgical removal of the contrast enhancement. This treatment will be performed in addition to the current reference treatment of glioblastoma: maximum removal surgery followed by radiochemotherapy according to the Stupp protocol.

Dose Finding for Intraoperative Photodynamic Therapy of Glioblastoma

A Multi-center Phase II Study With Light Dose Escalation During Intraoperative Photodynamic Therapy of Glioblastoma

Dose level above which TDL is observed in more than 33% (i.e., d̀-\> 2 of 6) of subjects in an arm

Number of patients without relapse within 25 mm of surgical site defined according to International RANO criteria

Median of progression-free survival time determined according to international RANO criteria

Median of OS determined according to international RANO criteria

Evaluated by MRI/ TEP 11C-MET every 3 months

Collection of all Adverse events (AEs and SAEs) (according to NCI-CTCE V5.0) and reviewing by an Independent Safety Monitoring Board

The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PDT Plus Vitamin D3 for Anal Dysplasia	NCT02698293	Anal Dysplasia Carcinoma in Si...	Gliolan Vitamin D3 chol... Photodynamic Th...	18 Years -	Abramson Cancer Center at Penn Medicine
PDT Plus Vitamin D3 for Anal Dysplasia	NCT02698293	Anal Dysplasia Carcinoma in Si...	Gliolan Vitamin D3 chol... Photodynamic Th...	18 Years -	Abramson Cancer Center at Penn Medicine
INtraoperative photoDYnamic Therapy of GliOblastoma	NCT03048240	Glioblastoma	"perPDT" GLIOLAN	18 Years -	University Hospital, Lille
Clinical Study on 5-aminolevulinic Acid Hydrochloride (5-ALA) for Fluorescence-guided Resection of Malignant Gliomas	NCT02755142	Brain Neoplasm	Gliolan	18 Years - 75 Years	medac GmbH
Radiodynamic Therapy (RDT) With Gliolan in Patients With First Recurrence of Brain Tumor	NCT05590689	Glioblastoma	Gliolan Radiodynamic th...	18 Years - 75 Years	Universität Münster
Dose Finding for Intraoperative Photodynamic Therapy of Glioblastoma	NCT04391062	Glioblastoma	Gliolan Intraoperative ...	18 Years -	University Hospital, Lille
INtraoperative photoDYnamic Therapy of GliOblastoma	NCT03048240	Glioblastoma	"perPDT" GLIOLAN	18 Years -	University Hospital, Lille
Clinical Study on 5-aminolevulinic Acid Hydrochloride (5-ALA) for Fluorescence-guided Resection of Malignant Gliomas	NCT02755142	Brain Neoplasm	Gliolan	18 Years - 75 Years	medac GmbH
Radiodynamic Therapy (RDT) With Gliolan in Patients With First Recurrence of Brain Tumor	NCT05590689	Glioblastoma	Gliolan Radiodynamic th...	18 Years - 75 Years	Universität Münster

Spots Global Cancer Trial Database for gliolan

Every month we try and update this database with for gliolan cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for gliolan

Every month we try and update this database with for gliolan cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for gliolan cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.