Neoplasms

All Conditions

Nervous System Diseases

Rare Diseases

Glioma

Glioblastoma

Brain Neoplasms

Astrocytoma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

All Drugs and Chemicals

Antineoplastic Agents

Vaccines

Temozolomide

Interleukin-12

Antineoplastic Agents, Alkylating

Alkylating Agents

Standard therapy with Surgery, Temozolomide, and Radiotherapy; plus Trivax, 5x10e6 autologous interleukine-12 secreting dendritic cells charged with autologous tumour lysate.

Trivax: 5 x 10e6 dendritic cells, intranodal in 500 µl NaCl, weeks 7, 8, 9, 10, 12, 16, 20, 24, 28, 32

Irradiation: 2 Gy per fraction once daily, five days per week (Mo-Fr), weeks 1, 2, 3, 4, 5, 6, total dose 60 Gy

Temozolomide concomitant to radiotherapy: 75 mg/m²/day, 5 days per week (Mo-Fr), weeks 1, 2, 3, 4, 5, 6.

Break: weeks 7, 8, 9, 10.

Temozolomide adjuvant: 150 mg/m²/day, five days per week (Mo-Fr), week 11; 200 mg/m²/day, five days per week (Mo-Fr), weeks 15, 19, 23, 27, 31.

Trivax, Temozolomide, Surgery, Radiotherapy

Irradiation: 2 Gy per fraction once daily, five days per week (Mo-Fr), weeks 1, 2, 3, 4, 5, 6, total dose 60 Gy

Temozolomide concomitant to radiotherapy: 75 mg/m²/day, 5 days per week (Mo-Fr), weeks 1, 2, 3, 4, 5, 6

Break: weeks 7, 8, 9, 10

Temozolomide adjuvant: 150 mg/m²/day, five days per week (Mo-Fr), week 11; 200 mg/m²/day, five days per week (Mo-Fr), weeks 15, 19, 23, 27, 31

Temozolomide, Surgery, Radiotherapy

Johanna Buchroithner, MD

A randomised, open-label, 2-arm, multi-centre, phase II clinical study with one group receiving standard therapy with Temozolomide, radiotherapy, and Trivax; and a control group receiving standard therapy with Temozolomide and radiotherapy only; after tumour resection of at least 70% in both groups. The hypothesis is based on the assumption that time to progression will be doubled in the treatment group.

Vaccination represents a success story in modern medicine and its principles have been found to be valid in different species, at least in the case of infectious diseases. As of today, there is little reason to believe that this would not be true in the case of tumours. It is now generally acknowledged that human tumours carry a mutational antigenic (non-self) repertoire of immunogenic potential that may be a suitable target for antitumour immune therapy. During the last years accumulating evidence from mouse experiments indicates that one can immunise prophylactically against cancers as effectively as against an infectious agent. However, in contrast to most experimental mouse tumour models, human tumours have in general been within their host for a long time and thus had the opportunity to influence their microenvironment and the larger immunological environment. Antigens capable of mediating specific rejection were found in human as well as in mouse tumours.

Many of the clinical trials using dendritic cell (DC) -based cancer vaccination techniques were designed for the treatment of melanoma. Other important diseases in which DC-based cancer vaccination was studied include prostate cancer, B cell lymphoma, renal cell carcinoma, glioma and glioblastoma, breast and ovarian cancer, gastrointestinal cancer, and selected solid paediatric tumours. In most of these trials some in vivo and/or in vitro evidence for the generation of anti-tumour immunity was found and even complete or partial remission of the tumour was observed in selected cases. The first phase III trial demonstrating the efficacy of DC cancer vaccination for the treatment of prostate cancer was reported recently (www.dendreon.com). Also patients suffering from glioblastoma multiforme appear to benefit from DC cancer immune therapy. The side effects observed in DC cancer vaccinations were usually described to be mild and not limiting the application.

We developed a DC cancer vaccine technology, Trivax, advancing the design of DC cancer immune therapy in one critical aspect. It is the first such vaccine that is enable for releasing the immune modulatory cytokine interleukin (IL) -12. Trivax is comprised of IL-12 secreting DCs and a mixture of protein tumour antigens derived from the individual patient's tumour cells. No synthetic tumour antigen component is involved. Both components of Trivax are derived from the individual patient and are used for the treatment of only this patient. Trivax therefore represents a fully individualised somatic cell therapy medicine. Trimed's early clinical evaluations in patients suffering from kidney cancer, prostate cancer, bone tumours, and malignancies of childhood have confirmed the safety and the feasibility of the Trivax technology.

Glioblastoma multiforme (GBM) (ICD-O M9440/3) is the most malignant astrocytic tumour, composed of poorly differentiated neoplastic astrocytes. Histopathological features include cellular polymorphism, nuclear atypia, brisk mitotic activity, vascular thrombosis, micro-vascular proliferation and necrosis. GBM typically affects patients of various age beginning in childhood and up to high age. It is preferentially located in the cerebral hemispheres. GBM may develop from diffuse astrocytomas WHO grade II or anaplastic astrocytomas (secondary GBM), but more frequently, they manifest after a short clinical history de novo, without evidence of a less malignant precursor lesion (primary GBM). In spite of modern oncological treatment, the prognosis of GBM remains dismal, with a median survival of little over 1 year.

GBM-Vax is a randomised, open-label, 2-arm, multi-centre, phase II clinical study with both groups undergoing surgery and receiving standard therapy with Temozolomide and radiotherapy; and the treatment group that in addition to the standard therapy receives cancer immune therapy with Trivax. Our aim is to extend therapy options presently including surgery, irradiation and Temozolomide with DC cancer vaccination to improve the poor prognosis of patients with GBM.

Primary objective

• Progression free survival measured as percentage of non-progressive patients with newly diagnosed GBM 12 months after a post-operative MRI scan treated according to the current standard (surgical resection, irradiation, oral chemo-therapy with Temozolomide), and Trivax, an autologous DC cancer vaccine charged with autologous tumour protein, as add-on therapy (group A), in comparison to patients receiving standard treatment without Trivax (group B).

Secondary objectives

* Progression free survival measured as percentage of non-progressive patients with newly diagnosed GBM 18 and 24 months after a post-operative MRI scan receiving standard treatment and Trivax as add-on therapy (group A), in comparison to patients receiving standard treatment without Trivax (group B).
* Extension of overall survival of patients with newly diagnosed GBM receiving standard treatment and Trivax as add-on therapy, in comparison to patients receiving standard treatment without Trivax.
* Quality of life in patients treated with Trivax as an add-on therapy using ECOG (Eastern Cooperative Oncology Group) performance status compared to qual-ity of life of patients receiving standard therapy (for study patients older 18 years).

Number of subjects In total, 56 patients will be enrolled in the study. The study consists of 2 arms and at least 28 patients should be randomly assigned to one of the two arms. It is expected to recruit the study patients within a period of one year. Randomisation is based on stratification according to study sites at a 1:1 ratio. Patients younger than 18 years will not be randomised but will all receive add-on therapy with Trivax. We feel that it would be not just to expect from children to understand and accept that there is a new treatment available but only every second patient will receive it. Obviously, patients younger than 18 years will not be analysed together with adult patients in the context of the study; and paediatric patients will not count towards the recruiting number of 2 x 28. Thus, the results obtained in paediatric GBM patients will not influence the outcome of the study in patients older than 18 years.

Dendritic Cell Cancer Vaccine for High-grade Glioma

First Line Standard Therapy of Glioblastoma Multiforme With or Without add-on Treatment With Trivax, an Anti-tumour Immune Therapy Based on Tumour-lysate Charged Dendritic Cells

Progression free survival measured as percentage of non-progressive patients with newly diagnosed GBM 12 months after a post-operative MRI scan treated according to the current standard (surgical resection, irradiation, oral chemotherapy with Temozolomide), and Trivax, an autologous DC cancer vaccine charged with autologous tumour protein, as add-on therapy (group A), in comparison to patients receiving standard treatment without Trivax (group B).

Quality of life in patients treated with Trivax as an add-on therapy using ECOG (Eastern Cooperative Oncology Group) performance status compared to quality of life of patients receiving standard therapy.

Progression free survival measured as percentage of non-progressive patients at 18 and 24 months post initiation of treat-ment.

The percentage of survival will be assessed at 12, 18, and 24 months.

Activartis Biotech

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

Digestive System Diseases

Gland and Hormone Related Diseases

Symptoms and General Pathology

Respiratory Tract (Lung and Bronchial) Diseases

Heart and Blood Diseases

Blood and Lymph Conditions

Mouth and Tooth Diseases

Uterine Cervical Neoplasms

Carcinoma

Cholangiocarcinoma

Breast Neoplasms

Pancreatic Neoplasms

Melanoma

Prostatic Neoplasms

Stomach Neoplasms

Anorexia

Vomiting

Head and Neck Neoplasms

Sarcoma

Carcinoma, Renal Cell

Neoplasm Metastasis

Lung Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Urinary Bladder Neoplasms

Headache

Liver Neoplasms

Seizures

Sleepiness

Mesothelioma

Mesothelioma, Malignant

Mitral Valve Insufficiency

Kidney Neoplasms

Esophageal Neoplasms

Thymoma

Thymus Neoplasms

Tongue Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Male Urogenital Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Neoplastic Processes

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urologic Diseases

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Adenocarcinoma

Adenoma

Neoplasms, Mesothelial

Thoracic Neoplasms

Esophageal Diseases

Lymphatic Diseases

Mouth Neoplasms

Mouth Diseases

Stomatognathic Diseases

Tongue Diseases

Esophageal Cancer

Pancreatic Cancer

Ovarian Cancer

Bile Duct Cancer

Renal Cell Carcinoma

Stomach Cancer

Ovarian Epithelial Cancer

Soft Tissue Sarcoma

Malignant Mesothelioma

Tongue Cancer

Oral Cancer

Bevacizumab

Intravenous administration of QBS10072S once every 4 weeks starting at 3mg/m2 and increasing dose levels in subsequent cohorts.

QBS10072S targets cancers with high LAT1 expression.

QBS10072S

This is a multi-center, open-label, dose escalation study to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and maximum tolerated dose (MTD) of QBS10072S in patients with advanced or metastatic cancers with high LAT1 expression. The MTD of QBS10072S will be confirmed in patients with relapsed or refractory grade 4 astrocytoma.

The dose escalation scheme for this trial employs an mTPI-2 design.

Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QBS10072S

A Phase 1, Open Label, Multi-Center, Single and Multiple Dose, Dose Escalation and Expansion Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QBS10072S in Previously Treated Patients With Advanced or Metastatic Cancers With High LAT1 Signatures, and in Patients With Relapsed or Refractory Grade 4 Astrocytoma

MTD will be determined by presence of AEs as characterized by type, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study therapy.

Safety and tolerability will be determined by adverse events as characterized by type, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study therapy.

Determine the maximum plasma concentration of QBS10072S.

Determine the plasma concentration of QBS10072S over time.

Determine the half life of QBS10072S in plasma; the half-life of a drug is the time taken for the plasma concentration of a drug to reduce to half its original value.

Determine the time it takes to achieve maximum concentration of QBS10072S in plasma.

Novotech (Australia) Pty Limited

Quadriga Biosciences, Inc.

Fluorodeoxyglucose F18

Radiopharmaceuticals

Scanning Procedure: Non-diagnostic Computed Tomography (CT) scan followed by a Diagnostic Positron Emission Tomography (PET) scan.

With each Positron Emission Tomography/Computed Tomography (PET/CT)scan an intravenous administration of radioactive glucose (FDG)is given. This is a weight dependent dosage.

[18F]-Fluorodeoxyglucose

Daniel P Levin, BSc,MD,FRCPC

This clinical trial is being conducted to study the use of a radioactive glucose tracer as an imaging test \[Positron Emission Tomography (PET)scan\] in adults who have or are suspected of having cancer and in another group of adults to assess for neurologic conditions.

18F-Fluorodeoxyglucose Positron Emission Tomography in Oncology and Neurology

The primary outcomes of sensitivity and accuracy of 18F-Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) studies will be obtained by comparing results of the PET scan with the gold standard of histopathological diagnosis when those results are available. Comparison to correlative imaging follow-up, and assessment of efficacy based on feedback from referring physicians will be used in the absence of pathologic data.

Winnipeg Regional Health Authority

University of Manitoba

Dr. Daniel Levin

Immunomodulating Agents

Adjuvants, Vaccine

Experimental:

ADCTA-G total 10 doses, each dose (30+/-5 millions autologous dendritic cells plus 6+/-0.5 millions 100Gy-irradiated short-term cultured autologous GBM tumor cells) divided in 2 halves for subcutaneous injection into both axillar areas, in a course of 6 months (sequential series of weekly injections 4 times, bi-weekly injections twice; then monthly injections 4 times.

Experimental: ADCTA-G total 10 doses, each dose (similar fore-mentioned numbers of 5:1 ratio of autologous dendritic cells and irradiated short-term cultured autologous GBM tumor cells) divided into 2 injections administered subcutaneously in both axillar areas, in a course of 8 months (sequential series of bi-weekly injections 4 times, then monthly injections 6 times).

Biological: ADCTA-G. Biological: autologous DC loaded with irradiated autologous tumor cells. Biological: dendritic cell "vaccine". Drug: 180mg/m2•per day temozolomide prior and concomitant with radiotherapy. Radiotherapy: Local ionizing radiation 200 centigray(cGy)/day, 5 successive days per week for 6 weeks, total dose of 6000 cGy.

Drug: Adjuvant chemotherapy-temozolomide (TMZ) monthly cycle, 200mg/m2•per day continued for 5 days in the beginning of every month, 6 cycles of TMZ.

Single arm, open-label

Wen-Kuang Yang, M.D. PhD.

Purposes:

The purpose of this phase-II clinical trial is to determine whether or not ADCTA-G, a biologic "vaccine" preparation of patient's own dendritic cell (DC) for glioblastoma multiforme (GBM) treatment, is safe and effective in extending the GBM patient's life. The current conventional multi-modal regimen that may include surgery for tumor resection or biopsy, temozolomide (TMZ) combined chemo-radiotherapy (CCRT) and TMZ adjuvant chemotherapy almost always leaves residual GBM cells to cause fatal recurrence, leading to medium survival period of 8 -15 months and over-all survival rates of about 30% in 2 years and \<3% in 5 years after diagnosis/surgery. Thus, in neurosurgical oncology practice, GBM patients in the first 2-year period during and after receiving multi-modal therapy are watched closely for possible GBM tumor recurrence and mortal disease relapse and immediately given palliative treatments and health care, until death. In this phase-II trial, GBM patient participants who receive ADCTA-G "vaccine" adjuvant immunotherapy (added to the conventional multi-modal regimen) will be similarly watched closely by treatments and health care visits at least biweekly from the date of surgery/diagnosis to 24 months, and if alive followed by weekly phone calls and scheduled health care visits at least once every 3 months, up to 72 months after surgery. In the trial protocol, ADCT-G in 10 doses is administered after surgery, over a period of 6 or 8 months, as an adjuvant immunotherapy of the conventional multimodal regimen. Individual ADCTA-G "vaccine" lot of every participant GBM patient is manufactured from patient's own monocyte-derived dendritic cells and the patient's own tumor cell antigens, both of which are prepared by a distinct method of procedures performed within air particle-free barrier good laboratory practice (GLP) facility. Previous phase I/II clinical trial of ADCTA-G "vaccine" immunotherapy administered as an adjuvant to the conventional multimodal regimen, has obtained promising safety and efficacy results for GBM patients in a clinical center. This phase-II clinical trial in China Medical University Hospital-Taichung will employ essentially the same clinical protocols and the same distinct "vaccine" manufacturing method of standard operational procedures (SOP), that is, the conventional multimodal regimen plus adjuvant immunotherapy using personal ADCTA-G "vaccine" lot for every GBM patient participants.

Rationale and Background :

Glioblastoma multiforme (GBM) and other WHO grade IV malignant gliomas of the brain are among the most lethal of human cancers. Despite current intensive multimodal regimen including the use of temozolomide (TMZ) for combined chemo-radiotherapy (CCRT) and for subsequent adjuvant chemotherapy, the medium survival period of GBM patients is still 8-16 months after diagnosis and surgery, with prognosis varied according to demographic features such as age, radiotherapy types and chemotherapy measures.These fatal brain cancers in general contain cancer cells with mutation in certain genes. Also, the mutated GBM cancer cells are usually heterogenous; and different GBM patients may have individual sets of heterogenous glioma cancer cells in which the mutant genes would generate altered antigens that can be recognized by the patient's adaptive immune system to mount immuno-targeting responses to reject or kill the GBM tumor cells. However, GBM is still fatal because it is highly immunosuppressive, i.e. able to anergize the immune effector cells in the body. Although surgical resection of rapidly expanding tumor bulk will prevent further physical damages to the brain and curtail the immunosuppression, the already anergized effector T lymphocytes still require functional restoration. On the other hand, post-surgical TMZ CCRT and adjuvant chemotherapy may weaken the residual tumor cells, but TMZ will also impair if not kill the active T lymphocytes in general, including anti-GBM lymphocytes. It is therefore important to exploit the adaptive immunity system for effective therapy of GBM. To apply the adaptive immunotherapy, it is best to use each patient's surgical tumor specimen to prepare the own individual "tumor regression antigens" for loading onto the patient's own dendritic cells (the "professional" antigen processing and presenting cells of the immune system). Dendritic cells loaded with tumor-specific antigens, upon maturation and inoculation ("vaccination"), would migrate/home to the T cell area of lymph nodes and stimulate proliferation of tumor-specific cytotoxic T lymphocyte that would move out of lymph node to find the brain tumor lesion to attack and eradicate the residual GBM tumor cells, resulting in prevention of GBM recurrence.

With fore-mentioned working hypotheses, the investigators carried out translational research from 1997 to 2002. A special method has been developed for production of an immunotherapeutic, which is named "autologous dendritic cell/autologous tumor cell antigens of GBM" (ADCTA-G). For clinical trial purpose, the investigators have established standard operational procedures (SOP) of the method with the use of clinical Good Manufacturing Practice (cGMP)-grade cytokines and pharmaceutical reagents. Individual ADCTA-G lots of all participant GBM patients are manufactured in high efficiency particle arresting (HEPA) air-filtered, germ-free bio-safety barrier clinical Good Laboratory Practice (cGLP) facilities. The phase I/II clinical trial was officially approved by Taiwan Department of Health and performed in a clinical center to demonstrate that ADCTA-G adjuvant immunotherapy was safe and apparently could prolong the survival for GBM patients.

Dendritic Cell-Based Tumor Vaccine Adjuvant Immunotherapy of Human Glioblastoma Multiforme (WHO Grade IV Gliomas)

Autologous Dendritic Cell-Based Adjuvant Immunotherapy of Malignant Gliomas (WHO Grade IV Glioblastoma Multiforme) - Phase II Clinical Trial

The primary end-point is overall survival (OS), days measured from post-recruitment surgery date (tumor resection or biopsy) to date of death due to GBM or other causes, and if alive, to date of weekly phone calls and health care visit every 3 months, up to 6 years. Survival days of patients are depicted on Kaplan-Meier plots to show the medium survival period (days when 50% patients remained alive) and annual rates (% living patients per total) every year up to 5 years, and by log rank test to find statistical probability p value.

Study groups of ADCTA-G immunotherapy plus conventional multimodal regimen will be compared to reference groups treated with conventional multimodal regimen (no ADCTA or other immunotherapy).

Acute or delayed/chronic adverse effects, graded according to NCI CTCAE Version 3.0, e.g. temozolomide combined chemo-radiotherapy(CCRT)-/GBM-caused lymphopenia, measured by lymphocytes/microL blood, and by % of patients with lymphopenia of grade 1, 2, 3, or 4 severity.

Progression-free survival period (days) is from date of surgery (tumor resection or biopsy) to date of neurological symptoms/signs relapse, verified by brain magnetic resonance (MRI) imaging, which is performed before and after surgery, and when symptoms and signs of disease progression occur, and subsequently one MRI scan in 3 months, till death or up to 6 years. The progression-free survival days of patient groups are depicted as Kaplan-Meier plots to show medium progression-free period (days when 50% patients remain free from GBM relapse) and annual rates (% progression-free patients of the total) from 1 to 5 years. Study groups of ADCTA-G immunotherapy plus conventional multimodal regimen will be compared to GBM reference groups with conventional therapy without immunotherapy.

Den-Mei Brain Tumor Education Foundation, Taichung, Taiwan

Ministry of Health and Welfare, Taiwan

China Medical University Hospital

Medical Chair Professor

Diseases and Abnormalities at or Before Birth

Sclerosis

Tuberous Sclerosis

Hamartoma

Neoplasms, Multiple Primary

Syndrome

Neoplastic Syndromes, Hereditary

Congenital Abnormalities

Malformations of Cortical Development

Nervous System Malformations

Neurocutaneous Syndromes

Heredodegenerative Disorders, Nervous System

Neurodegenerative Diseases

Genetic Diseases, Inborn

Tuberous Sclerosis Complex

Central Nervous System Depressants

Other Dietary Supplements

Benzocaine

Tannic Acid

Patients randomly allocated to this arm will receive treatment immediately. They will receive 6-12 sessions of ACT while patients allocated to the waitlist control arm do no receive any treatment.

Patients randomly allocated to this arm will receive a delay in the treatment they receive. After a 12-week wait they will receive 6-12 sessions of ACT, while patients allocated to the immediate treatment arm receive no treatment for an equal duration.

Acceptance and commitment therapy (ACT) is an evidence-based psychological therapy that has been successfully used to improve physical and mental health among children and adults with chronic conditions. It is a "third wave" cognitive behavioural therapy that encourages openness to and awareness of the present moment in order to help participants maintain behaviours consistent with their life goals. ACT fosters engagement with, rather than avoidance of, painful experiences to move towards acceptance of unchangeable difficulties alongside building a rich and meaningful life despite the presence of ongoing difficulties. This gives ACT strong face validity for application to TCS patients where there can be permanent cognitive impairment and unavoidable ongoing physical symptoms and functional limitations.

Acceptance and Commitment Therapy (ACT)

Sam Amin, MBCHB MSc PhD

The study will assess the acceptability and feasibility of a randomised controlled trial of 6-12 sessions of remotely-delivered Acceptance and Commitment Therapy (ACT) versus waitlist control. Waitlist control will involve a delay in the offer of ACT sessions for 12 weeks. Participants may access all services as usual in this time. Follow-up assessments will be conducted at 12-, 24 and 48 weeks post-randomisation to measure effectiveness.

Tuberous Sclerosis Complex (TSC) is a genetic disease caused by mutations in the tumour suppressor genes TSC1 and TSC2. The clinical hallmarks of the disease are the growth of benign tumours in various organs such as the brain, kidneys and skin. Seizures are present in around 60% of the population and neurodevelopmental problems such as attention deficit disorder and autism are common. Anxiety and depressive disorders are similarly linked and at the psychosocial level, there is increasing evidence of the effect of TSC on self-esteem, family functioning and peer relationships resulting in poorer quality of life. Despite these difficulties, no unique treatments, and almost no effective evidenced psychological treatments for TSC are available.

This trial aims to assess the feasibility and acceptability of Acceptance and Commitment Therapy (ACT) as a psychological treatment to improve quality of life among adolescents and young adults with TSC. ACT is a cognitive behavioural therapy that helps participants accept difficulties that they are unable to change. There is strong evidence for ACT's clinical effectiveness amongst patients with chronic diseases. The intervention will be delivered to participants aged 11-24 with TSC and sufficient cognitive and speech capabilities to take part. This will be delivered remotely via secure video-conferencing software. Our primary hypothesis is that ACT will be acceptable and feasible delivered remotely and may yield clinical improvements in health and quality of life.

The study will be a 12-week, waitlist controlled randomised clinical trial. Participants will be randomised to receive 12-weeks treatment either immediately or following a 12-week wait. The treatment will be ACT adapted for 11-24-year olds who have TSC. Treatment will involve 6 to 12 weekly sessions of ACT of up to one hour each in length. Clinical outcomes will be assessed unblinded at baseline, 12, 24 and 48 weeks from randomisation. As a feasibility and acceptability study a range of physical and mental health outcomes are assessed. All clinical outcomes focus on health, wellbeing and quality of life from baseline to 12 week (3-month) follow-up amongst those offered ACT immediately versus waitlist controls.

Randomised controlled trial of 6-12 sessions of ACT versus waitlist control. Waitlist control will involve a delay in the offer of ACT sessions for 12 weeks.

The study design is an unblinded, waitlist-controlled, randomised controlled trial (RCT). Randomisation will be conducted using established randomisation software RedCap. Researchers will not be blind to trial arm allocation.

Acceptance and Commitment Therapy in Tuberous Sclerosis Complex

Randomised Controlled Trial of Acceptance and Commitment Therapy in Tuberous Sclerosis Complex

The proportion of patients showing interest who then consent to the trial and complete the intervention.

The session attendance rate compared to feasibility benchmarks.

Assessing participant ratings of treatment credibility. Minimum score = 5; maximum score = 45. Higher scores indicate better outcome.

A questionnaire used nationally in child and adolescent mental health services completed by patients and parents/carers (if under 16) to assess participants' experience of the intervention. An additional item has been added to the experience of service questionnaire to assess video-conferencing treatment satisfaction. Minimum score = 0; maximum score = 20. Higher scores indicate better outcome.

A brief 7-item self-report measure assessing psychological inflexibility, which is the central treatment target for ACT. Validated for use among patients aged 16 and over. Minimum score = 7; maximum score = 49. Higher scores indicate worse outcome.

A brief self-report measure of psychological inflexibility, for children (11 to 15 year old participants). Minimum score = 0; maximum score = 32. Higher scores indicate worse outcome.

A brief self-reported assessment of wellbeing and mental health. Minimum score = 7 score; maximum = 49. Higher scores indicate worse outcome. Minimum score = 0; maximum score = 49. Higher scores indicate worse outcome.

A brief self-reported measure of generalised anxiety symptoms using 4-point Likert scales based on diagnostic criteria. Minimum score = 0; maximum score = 21. Higher scores indicate worse outcome.

Assesses symptoms of depression using self-reported 4-point Likert scales based on diagnostic criteria for major depression. Minimum score = 0; maximum score = 27. Higher scores indicate worse outcome.

A research instrument developed to collect information on service receipt, service-related issues and income. In addition, the Client Service Receipt Inventory collects information on school attendance in the 3-months prior to assessment.

Assesses behavioural, intellectual, learning and psychiatric impact of TSC.

A 23-item generic health status instrument with parent and child forms that assesses five domains of health (physical functioning, emotional functioning, psychosocial functioning, social functioning, and school functioning) in children and adolescents

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Dendritic Cell Cancer Vaccine for High-grade Glioma	NCT01213407	Glioblastoma Mu...	Trivax, Temozol... Temozolomide, S...	3 Years - 70 Years	Activartis Biotech
Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QBS10072S	NCT04430842	Astrocytoma Brain Cancer Brain Metastase... Bladder Cancer Breast Cancer Cervical Cancer Cholangiocarcin... Colorectal Canc... Esophagus Cance... Gastric Cancer Head and Neck C... Kidney Cancer Liver Cancer Lung Cancer Melanoma Ovarian Cancer Pancreatic Canc... Pleural Mesothe... Prostate Cancer Sarcoma Tongue Cancer Thymic Carcinom... Urinary Tract C...	QBS10072S	18 Years -	Quadriga Biosciences, Inc.
18F-Fluorodeoxyglucose Positron Emission Tomography in Oncology and Neurology	NCT01180751	Tumors	[18F]-Fluorodeo...	18 Years -	University of Manitoba
Dendritic Cell-Based Tumor Vaccine Adjuvant Immunotherapy of Human Glioblastoma Multiforme (WHO Grade IV Gliomas)	NCT02772094	Glioblastoma Mu... Glioblastoma	Single arm, ope...	13 Years - 70 Years	China Medical University Hospital
Acceptance and Commitment Therapy in Tuberous Sclerosis Complex	NCT05867576	Tuberous Sclero...	Acceptance and ...	11 Years - 24 Years	University Hospitals Bristol and Weston NHS Foundation Trust
18F-Fluorodeoxyglucose Positron Emission Tomography in Oncology and Neurology	NCT01180751	Tumors	[18F]-Fluorodeo...	18 Years -	University of Manitoba
Study of a Drug [DCVax®-L] to Treat Newly Diagnosed GBM Brain Cancer	NCT00045968	Glioblastoma Mu... Glioblastoma GBM Grade IV Astroc... Glioma Brain Cancer Brain Tumor	Dendritic cell ...	18 Years - 70 Years	Northwest Biotherapeutics

Spots Global Cancer Trial Database for neurology

Every month we try and update this database with for neurology 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 neurology

Every month we try and update this database with for neurology 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 neurology 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.