Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Behaviors and Mental Disorders

Symptoms and General Pathology

Carcinoma

Prostatic Neoplasms

Depression

Depressive Disorder

Fatigue

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Patients wear AYOpro BWL therapy glasses starting on day 1 of SOC ADT combination therapy for 12 months on trial.

Patients wear AYOpro BWL therapy glasses starting 6 months after the start of SOC ADT combination therapy for 6 months on trial.

Bright White Light Therapy

Combination Drug Therapy

Electronic Health Record Review

Quality-of-Life Assessment

Questionnaire Administration

William Dale

This phase II trial tests how well bright white light (BWL) therapy works in reducing cancer-related fatigue and depression in patients with prostate cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and who are undergoing treatment with antiandrogen therapy (ADT) combination therapy. Combination treatment including ADT plus chemotherapy and androgen receptor (AR) targeted therapy or ADT plus AR targeted therapies work by reducing testosterone. Most prostate tumor cells rely on testosterone to help them grow; therefore, ADT combination therapy causes prostate tumor cells to die or to grow more slowly leading to improved overall survival in men with advanced prostate cancer when compared with ADT alone. However, lower levels of testosterone is also commonly associated with worsening fatigue and depression. If prolonged and severe, these complications can alter patient treatment plans, impacting not just quality of life, but leading to inadequate cancer control. BWL therapy is a type of phototherapy that utilizes bright white full-spectrum light, either through a light box or light therapy glasses to help regulate circadian rhythms. Circadian rhythms are physical, mental, and behavioral changes that follow a 24-hour cycle, including the sleep-wake cycle which can become disrupted in cancer patients undergoing treatment, leading to increased fatigue. Additionally, exposure to bright light may increase the production of serotonin, a neurotransmitter that is associated with mood regulation. BWL therapy with AYOpro light therapy glasses may serve as a supportive care measure for men with advanced prostate to help reduce fatigue, as well as improve mood and overall quality of life during ADT combination therapy to maintain cancer care without suffering complications of therapy.

PRIMARY OBJECTIVE:

I. To evaluate whether patient-reported fatigue by the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue instrument at 3 months is lower in men with prostate cancer receiving immediate bright white light therapy as compared with delayed bright white light (BWL) therapy during ADT combination treatment (ADT + chemotherapy + hormonal intensification OR ADT+ hormonal intensification).

SECONDARY OBJECTIVES:

I. To evaluate the difference in the following outcomes between men with prostate cancer receiving immediate bright white light therapy as compared with delayed bright white light (BWL) therapy during ADT combination treatment (ADT + chemotherapy + hormonal intensification OR ADT + hormonal intensification):

Ia. Mood by the Patient Health Questionnaire (PHQ)-9 instrument measuring depressive symptoms; Ib. Geriatric assessments by the Cancer and Aging Research Group- Geriatric Assessment (CARG-GA) and Geriatric 8 (G8) instruments; Ic. Overall quality of life by the Functional Assessment of Cancer Therapy (FACT)-Prostate (FACT-P) instrument.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I (IMMEDIATE): Patients wear AYOpro BWL therapy glasses starting on day 1 of standard of care (SOC) ADT combination therapy for 12 months on trial.

GROUP II (DELAYED): Patients wear AYOpro BWL therapy glasses starting 6 months after the start of SOC ADT combination therapy for 6 months on trial.

Patients are followed for 52 weeks (total duration of the trial), or for 4 weeks including after removal from protocol therapy or until death, whichever occurs first.

In this study, only the designated study team member knows the participant's allocation. Oncologists or clinical research associates collecting data are not informed of patient allocation.

Bright White Light Therapy in Reducing Cancer-Related Fatigue and Depression in Advanced Prostate Cancer Patients Undergoing Treatment With ADT Combination Therapy

Phase 2 Study of Bright White Light During Treatment With ADT Combination Therapy in Men With Advanced Prostate Cancer to PreServe PHysIcal and MeNtal HEalth (SHINE)

Will compare patient-reported fatigue between men treated with immediate versus delayed bright white light (BWL) therapy during ADT combination treatment (ADT + chemotherapy + hormonal intensification OR ADT+ hormonal intensification). Measured by the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue instrument. T test will be used to compare FACIT-Fatigue change score between two arms (T2 \[3 month after treatment initiation\] minus T1 \[before or at treatment initiation\]).

Will compare the difference in mood between men with prostate cancer receiving immediate BWL therapy as compared with delayed BWL therapy during ADT combination treatment (ADT + chemotherapy + hormonal intensification OR ADT + hormonal intensification). Measured by Patient Health Questionnaire (PHQ)-9 instrument measuring depressive symptoms. T test will be used to compare PHQ-9 change score between two arms (T2 \[3 month after treatment initiation\] minus T1 \[before or at treatment initiation\]).

Will compare the difference in geriatric assessments between men with prostate cancer receiving immediate BWL therapy as compared with delayed BWL therapy during ADT combination treatment (ADT + chemotherapy + hormonal intensification OR ADT + hormonal intensification). Measured by Cancer and Aging Research Group- Geriatric Assessment (CARG-GA) and Geriatric 8 (G8) instruments. T test will be used to compare CARG-GA and G8 change scores between two arms (T2 \[3 month after treatment initiation\] minus T1 \[before or at treatment initiation\]).

Will compare the difference in overall quality of life between men with prostate cancer receiving immediate BWL therapy as compared with delayed BWL therapy during ADT combination treatment (ADT + chemotherapy + hormonal intensification OR ADT + hormonal intensification). Measured by Functional Assessment of Cancer Therapy (FACT)-Prostate (FACT-P) instrument. T test will be used to compare FACT-P change score between two arms (T2 \[3 month after treatment initiation\] minus T1 \[before or at treatment initiation\]).

National Cancer Institute (NCI)

City of Hope Medical Center

Gland and Hormone Related Diseases

Immune System Diseases

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Hypersensitivity

Ovarian Diseases

Endocrine Gland Neoplasms

Adnexal Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Endocrine System Diseases

Gonadal Disorders

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Gemcitabine

Carboplatin

Doxorubicin

Liposomal doxorubicin

Antimetabolites

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Women with platinum resistent ovarian cancer

Women with platinum sensitive ovarian cancer

AGS-8M4

Pegylated liposomal doxorubicin (PLD)

gemcitabine

carboplatin

Use Central Contact

This is a parallel arm study to evaluate AGS-8M4 administered in combination with chemotherapy in subjects with ovarian cancer. AGS-8M4 will be administered as an IV infusion until disease worsens.

All Subjects will receive AGS-8M4 treatment. Subjects will be enrolled into 1 of 2 treatment arms according to their disease status. A disease assessment will be performed every 8 or 9 weeks (± 3 days) depending on the treatment arm assignment. The assessment will be based both on changes in clinical symptoms, and radiographic images. Subjects without evidence of disease progression may continue to receive treatment based on their original treatment assignment until disease progression or intolerability. A safety follow-up visit will occur 4 weeks after the last dose infusion of AGS-8M4.

A Study of the Safety and Pharmacokinetics of AGS-8M4 Given in Combination With Chemotherapy in Women With Ovarian Cancer

A Phase 1b, Parallel Arm, Multicenter, Open-Label Study of the Safety and Pharmacokinetics of AGS-8M4 Given in Combination With Two Different Chemotherapy Regimens in Women With Platinum Resistant or Platinum Sensitive Ovarian Cancer

Agensys, Inc.

Astellas Pharma Inc

Glioblastoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Neuroepithelioma

Hypoglycemic Agents

Antihypertensive Agents

Anti-Inflammatory Agents

Psychotropic Drugs

Antiemetics

Gastrointestinal Agents

Central Nervous System Depressants

Anticonvulsants

Lipid Regulating Agents

Pharmaceutical Solutions

Cardiotonic Agents

Diuretics

Histamine Antagonists

Histamine H1 Antagonists

Antidepressive Agents

Ethanol

Immunosuppressive Agents

Antipsychotic Agents

Hypolipidemic Agents

Sclerosing Solutions

A Drug Combination Treatment will be determined through High Throughput Screening. The classes of drugs this combination therapy will be comprised from are:

Antineoplastic Anti-infective Antiemetic Antihyperlipidemic Anti-inflammatory Antihistamine Antihypertensive Antidepressant Cardiotonic Alcohol antagonist Diuretic Antipsychotic NMDA receptor antagonist Antidiabetic Immunosuppressant Anticonvulsant Antimethemoglobinemic Sclerosing agent

Up to 3 of 73 possible interventions from the drug classes listed below will be selected based on their potency against CSCs, potential for synergy without cross-reactive toxicities, drug safety profiles, pharmacokinetics, and drug-drug interactions. Those patients that have GBM that has recurred (as defined by RANO (45)), and for whom HTS was successfully completed, will be eligible to continue to the treatment component of the study to receive the drug cocktail comprised from the following drug classes:

Antineoplastic Anti-infective Antiemetic Antihyperlipidemic Anti-inflammatory Antihistamine Antihypertensive Antidepressant Cardiotonic Alcohol antagonist Diuretic Antipsychotic NMDA receptor antagonist Antidiabetic Immunosuppressant Anticonvulsant Antimethemoglobinemic Sclerosing agent

Charles Cobbs, MD

A study to determine the safety of CSC/ HTS-based combination drug therapy in subjects who have GBM that has recurred or progressed following prior radiation therapy and TMZ.

This protocol describes a prospective single-center Phase 0/1 open-label study to evaluate the safety and efficacy of a high-throughput drug sensitivity assay to predict targeted therapies for patients who have GBM that has recurred or progressed following prior radiation therapy and TMZ. The underlying hypothesis is that treatment of patients with up to 3 lead candidates identified from individualized CSC/ HTS assays will safely (1) delay disease progression, and (2) increase survival. There is an abundance of literature strongly supporting the importance of a regimen for targeting CSCs and preventing tumor recurrence, as an additional strategy to improve the overall prognosis of cancer patients.

Cancer Stem Cell High-Throughput Drug Screening Study

A Phase 0/1 Study of Combination Drug Therapy For Glioblastoma Based on Personalized Cancer Stem Cell (CSC) High-Throughput Drug Screening (HTS)

Swedish Medical Center

Digestive System Diseases

Pancreatic Neoplasms

Carcinoma, Pancreatic Ductal

Pancreatic Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Carcinoma, Ductal

Adenocarcinoma

Pancreatic Cancer

AGS-1C4D4

Chief Medical Officer

A study to evaluate AGS-1C4D4 administered in combination with Gemcitabine chemotherapy in subjects with Metastatic Pancreatic Cancer.

A disease assessment will be performed at study week 8 (± 3 days) by the investigator. The assessment will be based both on changes in clinical symptoms, and radiographic images. Subjects without evidence of disease progression may continue to receive treatment based on their original treatment assignment until disease progression or intolerability. Disease assessments will be performed every 8 weeks during the extended period. A safety follow-up visit will occur 4 weeks after the last dose infusion of AGS-1C4D4 and/or gemcitabine.

Post-Treatment: Subjects terminating from protocol therapy for reasons unrelated to documented disease progression will be followed by telephone contact every 2 months until they begin a new anticancer therapy, their disease progresses, they die, become lost to follow-up or withdrawal consent for further follow-up, whichever of these events occurs first.

Overall survival: All subjects will be followed by telephone contact every 2 months until death, loss to follow-up, or withdrawal of consent, whichever of these events occurs first.

A Study of AGS-1C4D4 Given in Combination With Gemcitabine in Subjects With Metastatic Pancreatic Cancer

A Global, Multi-center, Open-label, Phase 2 Study of AGS-1C4D4 Given in Combination With Gemcitabine in Subjects With Metastatic Pancreatic Cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Bright White Light Therapy in Reducing Cancer-Related Fatigue and Depression in Advanced Prostate Cancer Patients Undergoing Treatment With ADT Combination Therapy	NCT05869682	Advanced Prosta... Metastatic Pros... Prostate Carcin... Stage III Prost... Stage IV Prosta...	Bright White Li... Combination Dru... Electronic Heal... Quality-of-Life... Questionnaire A...	60 Years -	City of Hope Medical Center
A Study of the Safety and Pharmacokinetics of AGS-8M4 Given in Combination With Chemotherapy in Women With Ovarian Cancer	NCT01016054	Carcinoma Ovarian Cancer Ovarian Disease... Ovarian Neoplas...	AGS-8M4 Pegylated lipos... gemcitabine carboplatin	18 Years -	Astellas Pharma Inc
Cancer Stem Cell High-Throughput Drug Screening Study	NCT02654964	Glioblastoma Mu...	Combination Dru...	18 Years -	Swedish Medical Center
Cancer Stem Cell High-Throughput Drug Screening Study	NCT02654964	Glioblastoma Mu...	Combination Dru...	18 Years -	Swedish Medical Center
A Study of AGS-1C4D4 Given in Combination With Gemcitabine in Subjects With Metastatic Pancreatic Cancer	NCT00902291	Carcinoma, Panc... Pancreatic Canc... Pancreatic Dise...	AGS-1C4D4 Gemcitabine	18 Years -	Astellas Pharma Inc
Cancer Stem Cell High-Throughput Drug Screening Study	NCT02654964	Glioblastoma Mu...	Combination Dru...	18 Years -	Swedish Medical Center

Spots Global Cancer Trial Database for combination drug therapy