Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Neoplasms

Symptoms and General Pathology

Renal Insufficiency

Neoplasm Metastasis

Neoplasms, Second Primary

Neoplastic Processes

Kidney Diseases

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Carboplatin

Docetaxel

Albumin-Bound Paclitaxel

Vadimezan

ASA404

Novartis Pharmaceuticals

The purpose of this study is to determine the effect of the ASA404 infusion rate and co-administrating ASA404 with paclitaxel + carbopaltin chemotherapy regimen or docetaxel on the pharamcokinetics (PK) of free and total ASA404.

An Open-label, Dose Escalation Multi-center Study in Patients With Advanced Cancer to Determine the Infusion Rate Effect of ASA 404 With Paclitaxel Plus Carboplatin Regimen or Docetaxel on the Pharmacokietics of Free and Total ASA404

A Multi-center, Open-label, Dose-escalation Study in Patients With Advanced Cacner to Determine the Effect of the ASA404 Infusion Rate and Co-administration With the Paclitaxel Plus Carboplatin Regimen or Docetaxel on the Pharmacokinetics of Free and Total ASA404

Anti-Infective Agents

Vitamins

Acetic Acid

Retinol acetate

(5,6-dimethylxanthenone-4-acetic acid) DMXAA or DXAA

This study is designed to characterize the absorption, distribution, metabolism and excretion (ADME) of ASA404 following a single intravenous administration of 3000 mg (approximately 1800 mg/m2) ASA404 containing 60 µCi of 14C over a period of 20 minutes in patients with advanced solid tumors. Metabolic pathways, route (s) of elimination, distribution characteristics in plasma and blood, and exposure characterization in plasma and blood, and exposure characterization of the parent drug and metabolites will be obtained from the study.

A Single Center Study to Characterize the Absorption, Distribution, Metabolism and Excretion (ADME) of ASA404 After a Single Infusion in Patients With Solid Tumors

An Open-label Single Center Study to Characterize the Absorption, Distribution, Metabolism, and Excretion (ADME) of ASA404 After a Single Intravenous Infusion of 3000 mg [14C]ASA404 in Patients With Advanced Solid Tumor Malignancies

Disease Progression

Disease Attributes

Participants in the ConquerFear intervention group will receive a manualized intervention, consisting of 6 therapist-led individual sessions.

Participants in the CALM intervention group will receive a semi-structured, manualized, individual psychotherapy intervention consisting of 3-6 individual therapy sessions.

Basic Cancer Care serves as an active comparator and is not developed specifically to target fear of cancer recurrence through modifying participants' cognitive beliefs. Participants in this arm will receive 6 individual sessions including 2 relaxation training sessions, 2 dietetic consultation sessions, and 2 exercise sessions, which will be led by a trained therapist, a registered dietitian, and an exercise physiologist, respectively.

ConquerFear is a manualized intervention, consists of six individual sessions over 10 weeks. The key goals of this intervention are the following: (1) teach strategies for controlling worry and excessive threat monitoring, (2) modify underlying unhelpful beliefs about worry, (3) develop appropriate monitoring and screening behaviours, (4) encourage acceptance of the uncertainty brought about by a cancer diagnosis, and (5) clarify values and encourage engagement in values-based goal setting (19). Each session will last 60-90 minutes and be delivered by a trained therapist. After each session, participants will be given home-based exercises to practice the skills learned in the sessions. With the uncertainty surrounding the COVID-19 pandemic, instead of face-to-face sessions only, a hybrid mode of intervention delivery will be used by offering participants the choice of face-to-face or online sessions.

ConquerFear intervention

CALM is a semi-structured, manualized, individual psychotherapy intervention designed for patients with advanced cancer. It includes 3-6 individual therapy sessions, with each approximately lasts 45-60 minutes, delivered over 3-6 months. The sessions cover 4 domains: 1) symptom management and communication with health care providers; 2) changes in self and relations with close others; 3) sense of meaning and purpose; and 4) the future and mortality. All modules will be addressed with each patient, but the sequencing and time devoted to each domain can be varied, based on the concerns that are most relevant to each patient.

CALM intervention

Basic Cancer Care intervention for the control arm was developed to help cancer survivors with health maintenance in long-term through providing comprehensive lifestyle guidance. The intervention incorporates relaxation training, dietary and physical fitness consultations with the key goals to (1) teach relaxation techniques, (2) offer personalized diet and physical activity advice, and (3) enhance survivors' perceived control over illness, thereby leading to better adjustment to cancer. Similar to the ConquerFear intervention, Basic Cancer Care intervention consists of 6 individual sessions over 10 weeks. Each session will last 60-90 minutes and be delivered by a trained therapist, a registered dietitian, and an exercise physiologist, respectively. A hybrid mode of intervention delivery will be also used by offering participants the choice of face-to-face or online sessions.

Basic Cancer Care

Danielle Wing Lam Ng, PhD

Karen Chan

Wendy Chan

Dominic Foo

Ava Kwong

Wendy Wing Tak Lam, PhD

The present study aims to conduct a randomized controlled trial to assess the effect of CALM intervention and ConquerFear intervention on fear of cancer progression among Chinese patients diagnosed with advanced cancer.

A randomized controlled trial will be conducted to assess the effect of CALM intervention and ConquerFear intervention on fear of cancer progression among Chinese patients diagnosed with advanced cancer.

The aims are to test:

1. the direct effect of CALM intervention or ConquerFear intervention on fear of cancer progression, and
2. the indirect effect of ConquerFear intervention on fear of cancer progression through its effect on maladaptive metacognition.

Primary hypothesis:

1. Patients receiving CALM intervention or ConquerFear intervention, compared to those receiving a basic cancer care intervention will show a reduction in fear of cancer progression.
2. Both CALM intervention and ConquerFear intervention will be equally effective in reducing fear of cancer progression.
3. Given ConquerFear intervention aims to modify unhelpful metacognitive beliefs, there will be an indirect effect of ConquerFear intervention on fear of cancer progression through its effect on maladaptive metacognition.

The investigators will use a block randomization structure with randomly permuted block sizes of 3 and 6 to ensure a close balance of the numbers in each arm. Randomization (by a statistician) occurs prior to eligible patients attending the clinic to minimize opportunities for selection bias.

The investigator, care provider, and outcomes assessor are masked in terms of not knowing to which condition the participants will be randomized until after the completion of the baseline assessment. The outcomes assessor will break the envelope for the next eligible participant indicating if that participant is to be allocated to ConquerFear or CALM or control arms.

The participants are masked in terms of not knowing that the interventions (i.e. Conquer fear and CALM) are hypothesized to yield larger effects than the other (i.e. control).

Managing Fear of Cancer Progression Metacognition-based Vs Supportive-expressive Based Approaches

Managing Fear of Cancer Progression Metacognition-based Vs Supportive-expressive Based Approaches: A Randomized Controlled Trial

All IPD that underlie results in a publication will be available from the PI upon reasonable request.

The 12-item short version of the Fear of Progression Questionnaire (FoP-Q-SF) will be used to assess the change in total score of fear of caner progression. Each item of the FoP-Q-SF is rated on 5-point Likert scales anchored at 1 (Never) to 5 (very often). Higher scores indicate higher levels of fear of cancer progression. Total scores range from 12 to 60. A cutoff of 24-33 was used to suggest subthreshold level of fear of progression and a score of 34 or greater suggest high levels of fear of progression.

The 30-items Metacognitions questionnaire (MCQ-30) will be used to assess the change of metacognitive beliefs.Each item is rated on a 4-point Likert scale with a total score ranging from 30 to 120. High scores indicate a more maladaptive metacognitive style.

Change in total scores of depression will be assessed using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 score can range from 0 to 27, with higher scores indicative of a higher level of depression. The PHQ-9 is a reliable and valid 9-item measure of depression that has been used widely in advanced cancer patients.

Change in total scores of death anxiety will be assessed by the 15-item Death and Dying Distress Scale (DDDS). The DDS score can range from 0 to 90, with higher scores indicative of a higher level of death anxiety.

Research Grants Council, Hong Kong

The University of Hong Kong

Associate Professor

Skin and Connective Tissue Diseases

Breast Neoplasms

Carcinoma

Carcinoma, Squamous Cell

Recurrence

Head and Neck Neoplasms

Dermatologic Agents

Bleomycin

Photosensitizing Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

The photosensitiser Amphinex is activated by Laser to enhance the effect of Bleomycin

Amphinex

Laser

Martin Forster, MD

The primary goal of this extension study is to further investigate the tolerability and efficacy in a phase I setting in order to see whether lower doses than the initial study dose of 0.25 mg/kg bw Amphinex in Amphinex-based PCI of bleomycin will show a comparable or improved safety and tolerability profile in combination with comparable signs of efficacy.

Use of Amphinex for the enhancement of Bleomycin at the intracellular target. The photosensitizer Amphinex is activated by Laser Light at 652 nm.

Superficial lesions (cutaneous or subcutaneous) was treated with the laser light after administration of Amphinex and Bleomycin according to time scheduled provided.

Safety and preliminary effect data where evaluated at a lower dose than explored in the preceeding dose escalating study with Amphinex.

Dose Escalating Study for Amphinex-based PCI of Bleomycin.

Dose Escalating Study to Evaluate the Tolerability, Efficacy and Safety of Amphinex 0.125 mg/kg or Lower in Amphinex-based PCI of Bleomycin in Patients With Local Recurrence or Advanced/Metastatic, Cutaneous or Sub-cutaneous Malignancies.

Plasma samples for pharmacokinetic (PK) evaluation will be collected from patients and the presence of Amphinex and/or other unidentified metabolites will be assessed using a validated analytical method

Systematic skin photosensitivity tests will be carried out using a white light source with an emission spectrum that, relatively to the luminance and within +/- 50%, excites Amphinex with the same efficiency as sunlight. The luminance will be 500 lux, which is comparable to bright indoor light, and 100.000 lux, which is comparable to direct sunlight. The phototoxic reaction will be scored at specific time points following the light exposure (see the study flowchart Appendix B). This information will be used to predict the degree of photosensitivity of the skin.

Maximal pain during the procedure will be recorded immediately after the procedure on a 10 centimetre visual analogue scale (VAS). Pain will also be recorded 24 hours after the illumination and on day 4. The end-points of the VAS will be "no pain" and "unbearable pain

A formal efficacy analysis is not appropriate for this trial. The response data will be documented by descriptive summary tables. No statistical comparison of dose levels will be done. Fluorescence measurements over time and lesion response evaluation according to RECIST (see Appendix E) will be presented for APT and PP stratified by dose level.

* Summaries of the adverse event rates and laboratory changes from baseline stratified by dose level.
* Listings and frequency tables categorizing laboratory and non-laboratory adverse events by maximum CTCAE toxicity grade and relationship to study drug.
* Pain measurement, fluorescence measurement, skin photosensitivity measurement

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
An Open-label, Dose Escalation Multi-center Study in Patients With Advanced Cancer to Determine the Infusion Rate Effect of ASA 404 With Paclitaxel Plus Carboplatin Regimen or Docetaxel on the Pharmacokietics of Free and Total ASA404	NCT01240642	Metastatic Canc... Metastatic Canc...	ASA404	18 Years -	Novartis
A Single Center Study to Characterize the Absorption, Distribution, Metabolism and Excretion (ADME) of ASA404 After a Single Infusion in Patients With Solid Tumors	NCT01299701	Advanced Solid ...	ASA404	18 Years -	Novartis
Managing Fear of Cancer Progression Metacognition-based Vs Supportive-expressive Based Approaches	NCT05679518	Advanced or Met... Fear of Cancer ... Metacognition-b... Supportive-expr... Psychooncology	ConquerFear int... CALM interventi... Basic Cancer Ca...	18 Years -	The University of Hong Kong
An Open-label, Dose Escalation Multi-center Study in Patients With Advanced Cancer to Determine the Infusion Rate Effect of ASA 404 With Paclitaxel Plus Carboplatin Regimen or Docetaxel on the Pharmacokietics of Free and Total ASA404	NCT01240642	Metastatic Canc... Metastatic Canc...	ASA404	18 Years -	Novartis
Dose Escalating Study for Amphinex-based PCI of Bleomycin.	NCT01872923	Cutaneous or Su...	Amphinex Bleomycin Laser	18 Years -	PCI Biotech AS
A Single Center Study to Characterize the Absorption, Distribution, Metabolism and Excretion (ADME) of ASA404 After a Single Infusion in Patients With Solid Tumors	NCT01299701	Advanced Solid ...	ASA404	18 Years -	Novartis
A Single Center Study to Characterize the Absorption, Distribution, Metabolism and Excretion (ADME) of ASA404 After a Single Infusion in Patients With Solid Tumors	NCT01299701	Advanced Solid ...	ASA404	18 Years -	Novartis

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