Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Rare Diseases

Sarcoma

Respiratory Aspiration

Rhabdomyosarcoma

Myosarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Anti-Infective Agents

Irinotecan

Etoposide

Vinorelbine

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Vincristine

Ifosfamide

Dactinomycin

Etoposide phosphate

Isophosphamide mustard

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Tubulin Modulators

Antimitotic Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Participants will receive 42 weeks of conventional doses of vinorelbine, actinomycin D and cyclophosphamide

Participants will receive conventional doses of Vincristine/Actinomycin D/Cyclophosphamide (VAC) until complete response (CR) for 12-42 weeks and then switch to up to 2 years of vinorelbine/oral cyclophoshamide

Therapy with VAC that starts and stops based on response, adaptive timing of therapy, with a prolonged time to progression rather than complete remission goal

Participants will receive a chemotherapy combination based on published trials. An example would be 42 weeks of VAC but may also include irinotecan, doxorubicin, ifosfamide, etoposide.

IV push over 1 minute with dosing ranging from 0.24mg up to 1.5mg

IV over 60 minutes with dosing ranging from 220mg to 1200mg

IV push over 6-10 minutes with dosing ranging from 4mg-25mg

Actinomycin D should not be given with radiation. Will be administered through IV over 3-5 minutes with dosing ranging from 0.025mg-0.045mg

Actinomycin D

Based on Body Surface Area (BSA) round to nearest 25mg

Cyclophosphamide Pill

Jessica Crimella, BSN, RN

Stella Valavanis, MPH

Jennifer Madison

Bridget Tate

Elizabeth Alva, MD

Sarah Miller

Emily Blauel-Bocko, MD

Robin Arens

Michael Scott Isakoff, MD

Ashley P Bayne

Joanne P Lagmay, MD

Eva Pavicic

Aditi Dhir, MD

Brittani Froug

Emily Riffle

Jonathan Metts, MD

Jessica R Crimella, BSN, RN

Rebecca Zylber

Alice Lee, MD

Stephanie Guilford

Ajay Gupta, MD

Juanita Cuffee

Patrick Thompson, MD

Devika Srivastava

Abigail Moore

Javier Oesterheld, MD

Lars Wagner, MD

Melissa Serna

Matteo Trucco, MD

Hannah Johns

Bhuvana Setty, MD

Joshua Blatner

Scott Borinstein, MD

Nupur Goel

Patrick Leavey, MD

Latasha Williams

Jonathan Gill, MD

Jessica Jensen

Michelle Grant

Matthew Dietz, MD

This clinical trial will evaluate 4 different strategies of chemotherapy schedules in newly diagnosed participants with metastatic Fusion Positive (alveolar) Rhabdomyosarcoma. The participant and their physician will choose from: Arm A) a first strike therapy, Arm B) a first strike-second strike (maintenance) therapy, Arm C) an adaptively timed therapy, and Arm D) conventional chemotherapy.

Evolutionary Therapy for Rhabdomyosarcoma

Evolutionary Inspired Therapy for Newly Diagnosed, Metastatic, Fusion Positive Rhabdomyosarcoma

Participants who choose the first strike treatment will have event free survival assessed at 3 years after initiating treatment. Event free survival is defined as time from treatment initiation to event which includes (1) any recurrence (local or regional, or distant) and (2) death due to any cause.

Participants who choose the second strike treatment will have event free survival assessed at 3 years after initiating treatment. Event free survival is defined as time from treatment initiation to event which includes (1) any recurrence (local or regional, or distant) and (2) death due to any cause

Participants who choose the adaptive therapy will have event free survival assessed at 3 years after initiating treatment. Event free survival is defined as time from treatment initiation to event which includes (1) progression that does not respond to additional VAC dosing and (2) death due to any cause

The time to event endpoint of overall survival is defined as the duration of time from diagnosis to death or last follow-up, where event would be death from any cause

Number of participants with treatment-related adverse events of a certain grade or higher and hematological/biochemical toxicities based on laboratory measurements as assessed by CTCAE v5.0

National Pediatric Cancer Foundation

H. Lee Moffitt Cancer Center and Research Institute

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Digestive System Diseases

Behaviors and Mental Disorders

Lung Neoplasms

Prostatic Neoplasms

Fatigue

Urinary Bladder Neoplasms

Thyroid Neoplasms

Thyroid Diseases

Carcinoma, Renal Cell

Kidney Neoplasms

Colonic Neoplasms

Carcinoma

Intestinal Neoplasms

Rectal Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Urologic Neoplasms

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Colorectal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Kidney Diseases

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Rectal Diseases

Quality of Life

Renal Cell Carcinoma

Small Intestine Cancer

Herbal and Botanical

Cola

Participants will practice BMT under the instruction of a BMT instructor. There will be 24 sessions. Each session will last 60 minutes and will occur twice a week for 12 weeks. Each session will include both light physical exercise and mind training.

Sessions will be supplemented with home-based practice using an instructional DVD and handouts. Participants will be instructed to practice at least 30 minutes a day (at least 3 days per week) throughout the intervention and post-intervention period.

Body Mind Training (BMT)

Participants will practice BT under the instruction of a BT instructor. There will be 24 sessions. Each session will last 60 minutes and will occur twice a week for 12 weeks. Sessions will be supplemented with home-based practice using an instructional DVD and handouts. Participants will be instructed to practice at least 30 minutes a day (at least 3 days per week) throughout the intervention and post-intervention period.

Body Training (BT):

Participants in the usual care arm will receive care as normal and will not attend classes but will complete the same assessments as participants in the BMT and BT classes.

Usual Care (UC)

Anita Y Kinney, PhD, RN

Michael R. Irwin, MD

Project HERO is a 12-week study of the efficacy of Body Mind Training (BMT) for reducing fatigue in male cancer survivors. This 3-arm randomized clinical trial will examine inflammatory biology and selected gene-expression pathways that are hypothesized to contribute to the intervention's effect.

This study will establish the efficacy of a 12-week Body Mind Training (BMT) for reductions in fatigue (the study's primary outcome). Secondary patient-reported outcomes include quality of life changes (e.g. changes in sleep and perceived psychological distress), changes in the biomarkers of inflammation; including genome wide transcriptional factors, and expression of fatigue-related genes.

There are over 9 million cancer survivors that are 55 years of age or older. Cancer survivors in this age group have unique challenges coping with late and long-term effects of having had a cancer diagnosis and treatment, coupled with age-related declines and comorbidities. This may influence their ability to engage in lifestyle interventions because of slower post-treatment recovery, increased functional limitations, and other quality of life (QOL) impairments. Fatigue is common, under-recognized, undertreated and correlated with impairments in psychological distress, social and functional well-being and health-related QOL in cancer survivors. For male cancer survivors suffering from fatigue, body-mind training (BMT) may be more appealing because it is not overly physically exertive and is safe for people 55 years of age or older.

After obtaining informed consent and baseline assessments, 210 fatigued cancer survivors age 55 years and older will be randomized to the BMT arm or intensity-matched Body Training (BT), or Usual Care (UC) arms. Patient-reported assessments (surveys) will occur at baseline (within 2-weeks pre- intervention), mid-intervention (6 weeks), 1-week post-intervention (13 weeks), and at 3 months and 12 months post-intervention. Phlebotomy is done at baseline, 1 week post intervention (13 weeks), and 3 months and 12 months post intervention. Dietary assessments are done at baseline, and week 13 (1 week post intervention), 3 months and 1 year post-intervention. Physical activity is assessed weekly throughout the intervention. Sleep diaries are collected at all time points.

Participants will be instructed not to discuss their arm assignment with study personnel during their assessments; questionnaires will be self-administered, administered in person or by telephone based on participant need and preference. Some investigators, the data manager, biostatisticians, biometric testing and lab technicians will be blinded to intervention allocation. The technicians who analyze biospecimens will be blinded to all other data.

Project HERO: Health Empowerment & Recovery Outcomes

Biobehavioral Effects of Body Mind Training (BMT) for Male Cancer Cancer Survivors With Fatigue (HERO)

Change in fatigue levels over time: measured with 13-item scale assessing the level of fatigue during usual activities over the 7 days prior to the measurement timepoint, with higher scores indicating less fatigue. Administered at several time points to measure the effect the intervention.

Questionnaire: consists of 3 categories related to the risk of having sleep apnea. Patients can be classified into High Risk or Low Risk based on their responses to the individual items and their overall scores in the symptom categories.

Blood samples will be collected at using standardized procedures. The dynamics of inflammation will be measured by using a vertically integrated mechanistic approach and examining upstream signaling pathways and circulating levels. Circulating levels will be assessed by assay of plasma pro- and anti-inflammatory biomarkers; Inflammatory signaling as indexed by activation of key inflammatory transcription factors (e.g., NF-κB) will be measured using intranuclear staining and flow cytometric analyses. Genome-wide transcriptional analyses (all baseline and 13-week biospecimens) will be used to identify the differential regulation of gene expression and the molecular inflammation-related signaling pathways that are plausible candidates driving these changes (e.g., NF-κB).

Specimen collection and analysis to measure mRNA intercorrelations: 1) Inflammation, Vasodilation, and Metabolite Sensing and 2) Energy and Adrenergic Activation.

Questionnaire: Psychological distress (depression and anxiety) is measured using the using the Brief Symptom Inventory-18 instrument. Items are summed to calculate the raw score, range 0-72. Raw scores can be converted to T-scores, based on US population norms. Participants with T-scores that are ≥ 63 are considered a "case," and may need professional help. Somatization Scale: Raw score range 0-24, with 24 indicating high somatization. Depression Scale: Raw score range 0-24, with 24 indicating high depression. Anxiety Scale: Raw score range 0-24, with 24 indicating high anxiety.

Questionnaire: Provides scores for each of the eight health domains and psychometrically-based physical component summary (PCS) and mental component summary (MCS) scores. The raw score of each of the eight SF-36 dimensions was derived by summing the item scores. Subtract the lowest possible raw score from the actual raw score, divide by the possibly raw score range, and multiply by 100 to get the transformed scale. Higher scores indicate better health-related quality of life.

The sleep diary is designed to gather information about daily sleep patterns. Sleep diary is maintained for 7 days prior to each data collection time point.

University of California, Los Angeles

University of New Mexico

Rutgers, The State University of New Jersey

Study Principal Investigator; Associate Director for Cancer Health Equity

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Evolutionary Therapy for Rhabdomyosarcoma	NCT04388839	Rhabdomyosarcom...	Vincristine Cyclophosphamid... Vinorelbine Actinomycin D Cyclophosphamid...	-	H. Lee Moffitt Cancer Center and Research Institute
Project HERO: Health Empowerment & Recovery Outcomes	NCT03345563	Prostate Cancer Bladder Cancer Kidney Cancer Colon Cancer Rectum Cancer Thyroid Cancer Lung Cancer Small Intestine... Soft Tissue Can...	Body Mind Train... Body Training (... Usual Care (UC)	55 Years -	Rutgers, The State University of New Jersey

Spots Global Cancer Trial Database for soft tissue cancer