Neoplasms

All Conditions

Neoplasms, Second Primary

* co-construction of supervised and non-supervised physical activity sessions with a physical activity trainer
* balance sheet (at diagnosis and 4 monthes+/- 2 months later) : IPAQ, QLQC30, 6-min walk test, anthropometric evaluation
* meetings and phone calls after the physical activity program to assess patient perception and satisfaction, and provide information and recommendations for cancer prevention

Providing a supervised and non-supervised physical activity program for adolescent and Young adult with cancer and improve awareness on cancer prevention recommendations (second cancer risk, healthy lifestyles...)

Physical activity program and prevention after cancer

Perrine MAREC-BERARD, MD

About 700 new cases of cancer are recorded each year among TYAC aged 15 to 25 years old in Rhône-Alpes region (France); more than 200 are treated and supported within the TYAC Department of the Institute of Hematology and Oncology Pediatrics (Centre Léon Bérard-Civil Hospice of Lyon). These patients survive from their disease in 80% of cases; they have six times more likely to develop a risk of second primary cancer (SCP) than their peers. This risk of SCP is multifactorial and varies depending on the type of first cancer, treatment received and the prevalence of risk factors (smoking, overweight, sedentary lifestyle, environmental exposures...). This project aims to implement a clinical program based on adapted physical activity (APA) and cancer prevention recommendations for TYAC during the active treatment period (4-6 months). The methodology used series of assessments of APA sessions and information meetings dedicated to cancer prevention and SCP risk recommendations. It mobilizes regularly the health care team of TYAC Department, TYAC associations, sports structures and associations involved in cancer prevention at the regional level. Assessment of TYAC satisfaction regarding the project, benefits in terms of exercise practice, and knowledge improvement on cancer prevention recommendations, are assessed throughout the program.

Implementation of a Program Based on Adapted Physical Activity and Recommendations for Second Cancers Prevention for TYACs

Implementation of a Program Based on Adapted Physical Activity and Recommendations for Second Cancers Prevention for Teenagers and Young Adults With Cancer

International Physical Activity Questionnaire

Centre Leon Berard

Behaviors and Mental Disorders

Quality of Life

Qualitative data collection will occur through one-on-one semi-structured interviews with AYA patients (n=36). AYA patients are eligible if they: (1) are 15 to 39 years of age, (2) were diagnosed with cancer at 15 to 39 years of age; (3) are able to read and understand English; (4) have a new cancer diagnosis and are receiving curative treatment OR are currently 0 to 5 years post-treatment. AYA patients will be excluded if they: (1) were diagnosed with basal cell skin cancer; (2) experienced a cancer recurrence; (3) are currently receiving palliative or hospice care; (4) had an infertility diagnosis prior to their cancer diagnosis, or (5) report a significant psychiatric history.

Qualitative data collection will occur through one-on-one semi-structured interviews with AYA providers (n=36). Providers will be health professionals who provide supportive care for AYAs to help address financial, body image, and fertility/future parenthood concerns or needs. Psychosocial providers (e.g., social workers, patient navigators, psychologists) will all be eligible to participate. We will also include reproductive endocrinologists, nurse practitioners, and other medical professionals who have expertise in the appropriate area of health-related quality of life (HRQOL). Additional inclusion criteria will be: (1) provision of care to AYAs; (2) ≥2 years practicing; (3) English-speaking.

Qualitative data collection will occur through one-on-one semi-structured interviews with content experts (n=36). Content experts are a purposive sample of scientists and clinicians who have recognized expertise in each of the three domains of interest to this project - financial burden, body image, and fertility/future parenthood.

Five forms have been created for AYA patients (n=25). Each form consists of 25 to 30 items. Forms for AYA patients include an even number of items from the body image, financial burden, and fertility domains counterbalanced in order of administration to reduce the potential for order effects. Participants will also complete a sociodemographic form and, to evaluate literacy and reading grade equivalent, an interviewer-administered Wide Range Achievement Test (WRAT-5) will also be completed. Only the Word Reading portion of the WRAT-5 will be administered to the participants. Cognitive interviews will be conducted over 2 rounds with half the sample comprising each round. Items substantially revised from Round 1 will be re-evaluated in Round 2.

Two forms for AYA caregivers (n=10). Each form consists of 25 to 30 items. Forms for AYA caregivers only include items from the financial burden domain. Participants will also complete a sociodemographic form and, to evaluate literacy and reading grade equivalent, an interviewer-administered Wide Range Achievement Test (WRAT-5) will also be completed. Only the Word Reading portion of the WRAT-5 will be administered to the participants. Cognitive interviews will be conducted over 2 rounds with half the sample comprising each round. Items substantially revised from Round 1 will be re-evaluated in Round 2.

John M Salsman, Ph.D.

Regina Smith, BS, CCRP

David E Victorson, Ph.D.

John M Salsman, PhD

AIM1a:

AYAs with cancer experience many challenges that impact their health-related quality of life (HRQOL) but few measures adequately capture AYAs' HRQOL in valid and reliable ways. The main goal of the study is to expand the use of the Patient-Reported Outcome Measurement Information System (PROMIS) to provide valid and reliable assessment of important HRQOL concerns for AYAs. The study team will do this by validating existing PROMIS measures and developing and validating new measures of financial distress, fertility/parenthood concerns, and body image concerns for AYAs with cancer.

AIM1b:

Investigators have developed conceptual frameworks and created item pools for body image, fertility, and financial burden domains and are ready to proceed with the next aim of our measure development work, cognitive interview testing.

AIM1a:

There are approximately 70,000 new diagnoses of cancer annually in adolescents and young adults (AYAs; ages 15-39), and nearly 2 million people in the United States are living with or have survived being diagnosed with cancer as an AYA. Despite the high number of AYA survivors, survival rates of AYAs have not kept pace with those of their younger or older counterparts. AYAs face unique challenges given the physical, cognitive, and psychosocial developmental milestones that may be disrupted as a result of their cancer experience. In addition to the age-related disparities in survival rates, AYAs are at greater risk of significant psychological and financial distress compared to older adults with cancer. Accordingly, assessing and better understanding the unique needs and health-related quality of life (HRQOL) of this important, underserved group as they manage their cancer experience is essential in order to optimize and tailor supportive care approaches.

A few HRQOL conceptual frameworks exist that describe the types of symptom burden and functional impact experienced by AYAs with cancer, but most HRQOL measures fail to capture the range of HRQOL domains that are important to AYAs. Further, measures of HRQOL specifically developed for AYAs lack common items and standardized scoring approaches across the age range of 15-39, limiting the ability to understand the unique needs of this age group. The NIH's Patient-Reported Outcomes Measurement Information System (PROMIS) assesses most of the relevant HRQOL domains (pain, fatigue, anxiety, depression, cognitive functioning, physical functioning, sexual functioning, and social support) but has not been validated in AYAs and PROMIS does not include key domains such as financial distress, body image concerns, or fertility/ parenthood concerns that provide a complete perspective of HRQOL in AYAs with cancer.

The main objective of the study is to expand the use of PROMIS to provide reliable and valid assessment of important HRQOL concerns for AYAs. To accomplish this goal, the study team propose the following specific aims: (1) develop item pools of financial distress, body image concerns, and fertility/parenthood concerns for AYAs with cancer using PROMIS measurement development methodologies; (2) calibrate item banks and short forms of financial distress, body image concerns, and fertility/ parenthood concerns in a large, developmentally diverse sample of AYAs with and without cancer; and (3) validate newly developed short forms of financial distress, body image concerns, and fertility/ parenthood concerns along with existing PROMIS short forms in a developmentally and clinically diverse, prospective sample of AYAs with cancer.

At the end of this research study, the investigators will have a psychometrically robust, state-of-the-art measurement system tailored to AYAs' unique HRQOL needs. Through the identification, adaptation, and development of reliable, valid, and responsive measures of HRQOL for AYAs with cancer, the investigators will give these underserved patients a voice and provide the assessment tools clinicians and researchers need to enhance patient-centered care.

AIM1b:

In this project, are utilizing the cutting-edge measures and scientific standards of the PROMIS in the development of new item banks for financial burden, body image, and fertility, and in the examination of the psychometric properties of existing PROMIS measures for use in AYAs with cancer. For the purposes of this current protocol, investigators will focus on the cognitive interview stage of this process to evaluate the comprehensibility of the preliminary item pools.

Measuring Health Related Quality of Life in AYAs

Optimizing Health Related Quality of Life Measurement in Adolescent and Young Adult Oncology:

Guided by the interviews with AYA patients, AYA providers, and content experts, and the discussions with our project team, we will identify a conceptual framework for financial burden that will guide the identification and writing of self-report items to assess this important dimension of health-related quality of life among AYAs.

Guided by the interviews with AYA patients, AYA providers, and content experts, and the discussions with our project team, we will identify a conceptual framework for body image that will guide the identification and writing of self-report items to assess this important dimension of health-related quality of life among AYAs.

Guided by the interviews with AYA patients, AYA providers, and content experts, and the discussions with our project team, we will identify a conceptual framework for fertility and future parenthood that will guide the identification and writing of self-report items to assess this important dimension of health-related quality of life among AYAs.

Investigators will ascertain: (a) comprehension of the question (i.e., what does the respondent believe the question is asking; what do specific words, phrases and concepts in the question mean to the respondent); (b) the processes used by the respondent to retrieve relevant information from memory (i.e., what does the respondent need to recall to be able to answer the question; what strategies does the respondent use to retrieve the information); and (c) response processes (i.e., can the respondent match his/her response to the question's response options). Participant responses to interview questions will be coded 0 or 1 reflecting adequate comprehension or misunderstanding. Translatability review will also be conducted by FACITtrans to identify items/concepts that may not translate easily or prove to have limited or no conceptual equivalence in other cultures and to suggest alternative wording changes.

Northwestern University Feinberg School of Medicine

Wake Forest University Health Sciences

Children, adolescents, and young adults diagnosed with cancer before the age of 40 enrolled at any point during the diagnosis-treatment-survivorship continuum.

Andrew Smitherman, MD

Lauren Lux, MSW

Purpose: This study aims to create a registry of childhood, adolescent, and young adult patients with cancer (\<40 years-old at cancer diagnosis), entitled the 'UNC Childhood, Adolescent, and Young Adult Cancer Cohort' (UNC-CAYACC). This resource will serve to support cancer outcomes research among pediatric and young adult cancer patients with a primary focus on enrolling patients treated as adolescents or young adults (AYAs, 15-39 years).

Procedures: As appropriate for age, participants will complete physical and cognitive functional assessments; questionnaires to assess health-related quality of life and other patient-reported outcomes; will undergo body composition and anthropometric measurements; and will be asked to provide biospecimens for biobanking. Assessments will be collected (as possible) at diagnosis, during active treatment, following treatment completion, and annually in survivorship to assess outcomes throughout the treatment and survivorship trajectory. Sociodemographic and clinical information such as cancer treatment modalities and cumulative doses will be collected by medical record abstraction. Participants will be eligible to enroll at any time from diagnosis through survivorship. This registry will provide data to better understand the manifestations of accelerated aging and key contributing factors among children, adolescents, and young adults with cancer.

Up to 22.5 milliliters of peripheral blood

UNC Childhood, Adolescent, and Young Adult Cancer Cohort

De-identified aggregate data will be available upon request. De-identified or coded individual data from the registry may be made available upon request following completion of necessary data use agreements and with Institutional Review Board (IRB) approval.

Creation of a registry of pediatric and young adult patients with cancer treated within the University of North Carolina Health System

Assess feasibility for completing repeated physical and cognitive functional assessments among young cancer survivors. These assessments include measures of physical and general frailty.

Assess feasibility for collection of sociodemographic (including social determinants of health), cancer (e.g., site and stage), and treatment (e.g., modalities and cumulative doses) variables using patient questionnaires and medical record abstraction.

Assess feasibility for the repeated collection of patient-reported measures of health-related quality of life, health behaviors, and functional status.

Hyundai Hope On Wheels

UNC Lineberger Comprehensive Cancer Center

Symptoms and General Pathology

Fatigue

Death

Single-arm pilot study of a 7-week home/hospice-based Hatha yoga program for adolescent and young adults with non-curative cancer.

This is a 7-week home/hospice-based instructive Hatha yoga program (available on DVD) for adolescent and young adults diagnosed with a non-curative cancer. Participants will be asked to complete a minimum of one, 75-minute yoga session per week. The DVD package includes four discs that increase in difficulty over the course of the 7-week program. The DVD focuses on postures and breathing exercises. Participants will be asked to keep track of the number and duration of yoga sessions completed over the 7-week period.

Hatha Yoga

Rob Rutledge, MD, FRCPC

Adolescents and young adults who are living with cancer are not benefiting from the same age-appropriate physical and psychosocial care, as are children and older adults. As a result, their unique needs often go unmet or unaddressed. Studies have demonstrated that a lack of age-appropriate care may be responsible for a deceased quality of life. Studies have also shown that physical activity is able to reduce many of the negative side-effects linked to cancer and its treatment (e.g., nausea, vomiting, fatigue). A light form of physical activity that is both safe and manageable for cancer patients is yoga. The purpose of this study is to examine the achievability and safety of a light 7-week home/hospice-based Hatha yoga program (available on DVD) in the adolescent and young adult non-curative cancer population. This study will also examine the ability of yoga to reduce cancer related side effects.

Yoga for Adolescent and Young Adult Non-Curative Cancer Patients

Impact of Yoga on Quality of Life for Adolescent and Young Adult Non-Curative Cancer Patients: A Pilot Study

Recruitment will be calculated by the number of patients who consent to participate, divided by the number of eligible participants recommended by the primary oncologist/physician.

Retention: Will be determined by reporting the number of participants who complete the baseline and post-program questionnaire and follow-up testing.

Adherence: Participants will be asked to record the number of yoga sessions performed each week. Overall adherence will be calculated by summing the actual number of sessions the participant engaged in, divided by the recommended number of sessions.

Safety: Any adverse events reported by the participant will be recorded.

Participants will be asked to complete the Functional Assessment of Chronic Illness Therapy - Palliative Care subscale (FACIT-Pal) and the Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being subscale (FACIT-Sp) at baseline and post-intervention.

Dalhousie University

IWK Health Centre

Nova Scotia Health Authority

Rob Rutledge

Associate Professor, Department of Medicine, Dalhousie University

Central Nervous System Depressants

All Drugs and Chemicals

Other Dietary Supplements

Benzocaine

Tannic Acid

Participants will receive an initial individual session, physical activity tracker, weekly behavioral lessons, tailored feedback summaries, and access to a Facebook group immediately after baseline assessments.

Participants will receive a physical activity tracker and be advised to maintain their current activity. After 3 months, participants will receive an initial individual session, weekly behavioral lessons, tailored feedback summaries, and access to a Facebook group.

Individual session, physical activity tracker, online intervention

Intervention

Carmina G. Valle, PhD, MPH

John M. Salsman, PhD

The purpose of this study is to examine the feasibility, acceptability, and gather preliminary data on outcomes of a 3-month mHealth intervention to promote physical activity among adolescent and young adult (AYA) cancer survivors compared to a delayed intervention control group.

Adolescent and young adult (AYA) survivors are not meeting recommended physical activity guidelines for cancer survivors, and few interventions to date have focused specifically on promoting physical activity among AYAs or capitalized on new technologies to deliver them. This is a pilot randomized controlled trial (RCT) to examine the feasibility, acceptability, and gather preliminary data on outcomes of a 3-month mHealth intervention to promote PA among AYA survivors compared to a delayed intervention control group. This project will focus on how to best integrate self-monitoring with wearable trackers, increase self-efficacy, enhance autonomous motivation, and promote social support in a mobile health behavioral intervention that promotes moderate-to-vigorous intensity physical activity (MVPA) among AYA survivors. Participants will be AYA cancer survivors (N=60), diagnosed at age 15 or older and currently age 18-39. AYA cancer survivors will be recruited from the three comprehensive cancer centers in North Carolina to participate in this study. The behavioral intervention will consist of an activity tracker, Facebook group, weekly email lessons, and weekly tailored feedback emails. Assessments of objectively-measured physical activity and other outcomes will be completed at baseline, 3, and 6 months.

mHealth Physical Activity Intervention for Survivors of Adolescent and Young Adult Cancers

Change in posttraumatic growth, as measured by the Short Form of the Posttraumatic Growth Inventory, from baseline to 3 months, and 3 months to 6 months. Responses range from 0 to 5 and yield an overall score and subscale scores for relating to others, new possibilities, personal strength, spiritual change, and appreciation of life. Items are summed, with higher scores reflecting more positive change (i.e., posttraumatic growth).

Changes in positive psychosocial impact of illness, as measured by the PROMIS Psychosocial Illness Impact - Positive (4a), from baseline to 3 months, and 3 months to 6 months. Responses to the 4-item short from range from 1 to 5. Items are summed, with higher scores reflecting more positive psychosocial impact.

Changes in positive psychosocial impact of illness, as measured by the PROMIS Psychosocial Illness Impact - Negative (4a), from baseline to 3 months, and 3 months to 6 months. Responses to the 4-item short from range from 1 to 5. Items are summed, with higher scores reflecting more negative psychosocial impact.

Changes in positive affect, as measured by the NIH Toolbox Positive Affect Short Form, from baseline to 3 months, and 3 months to 6 months.

Changes in positive affect, as measured by the Network Orientation Scale, from baseline to 3 months, and 3 months to 6 months. Responses to 20 items range from 1 to 4. Items are summed (range: 20 to 80), with higher scores representing a more negative social network orientation.

Number of participants who agreed to participate divided by the number of months of recruitment.

Percentage of eligible participants who agreed to participate.

Number of intervention participants who completed 3-month measures divided by the number who consented to participate.

Number of intervention participants who completed 6-month measures divided by the number randomized to the intervention group.

Ratings of satisfaction with the intervention, as measured by satisfaction questionnaire.

Number of days physical activity tracked, as measured by Fitbit.

Change in objective levels of physical activity, as measured by accelerometry (Actigraph), from baseline to 3 months, and 3 months to 6 months.

Change in self-report levels of physical activity, as measured by the Godin Leisure Time Exercise Questionnaire, from baseline to 3 months, and 3 months to 6 months.

Change in self-report levels of sedentary behavior, as measured by the Marshall Sitting Time Questionnaire, from baseline to 3 months, and 3 months to 6 months.

Change in self-reported weight, from baseline to 3 months, and 3 months to 6 months.

Change in intrinsic motivation, as measured by the intrinsic motivation subscale of the Treatment Self-Regulation Questionnaire for Exercise, from baseline to 3 months, and 3 months to 6 months. Responses to four items comprising intrinsic motivation subscale are averaged to yield a score from 1 to 7, with higher values representing higher intrinsic motivation.

Change in self-efficacy for exercise, as measured by the Self-Efficacy and Exercise Habits Survey, from baseline to 3 months, and 3 months to 6 months. Responses for two subscales (Sticking to it, Making time for exercise) are averaged to yield a score from 1 to 5, with higher values representing higher self-efficacy for exercise.

Change in social support for exercise, as measured by the Social Support for Exercise Survey, from baseline to 3 months, and 3 months to 6 months. Responses for three factors (Family participation, Friend participation, Friends on social networking sites participation), ranging from 1 to 5, are summed, with higher values representing higher social support for exercise.

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Diseases and Abnormalities at or Before Birth

Rare Diseases

Sarcoma

Osteosarcoma

Wilms Tumor

Neuroblastoma

Sarcoma, Ewing

Rhabdomyosarcoma

Hepatoblastoma

Soft Tissue Sarcoma

Germ Cells Tumors

Wilms' Tumor

Ewing Sarcoma

Antineoplastic Agents

Gemcitabine

Paclitaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Participants receiving gemcitabine and nab-paclitaxel for refractory and/or relapsed solid tumors of childhood.

Gemcitabine will be administered intravenously once weekly over 60 minutes every 3 out of four weeks. The dose of gemcitabine will start at 675 mg/m2/dose. If the MTD has been exceeded at the Dose Level 1, then the subsequent cohort of participants will be treated with gemcitabine at a dose of 500 mg/m2/dose (Dose Level 0).

Nab-Paclitaxel will be administered intravenously over 30 minutes once weekly every 3 out of 4 weeks. Nab-paclitaxel will be administered prior to administration of gemcitabine. The starting dose of nab-paclitaxel will be 180 mg/m2/dose (dose level 1). Dose levels for subsequent groups of subjects are 210 mg/m2/dose (for dose level 2) and 240 mg/m2/dose (for dose level 3).

Nab-paclitaxel

Thomas Cash, MD, MSc

Jonathan Metts, MD

This is a research study for people who have a solid tumor that was not effectively treated by conventional therapy or for which there is no known effective therapy. This is a phase I study of a drug called nab-paclitaxel used together with gemcitabine. Gemcitabine and nab-paclitaxel will be given intravenously, once a week for 3 out of 4 weeks, for a 28-day cycle.

The goals of this study are:

* To find the highest dose of nab-paclitaxel that can be safely given in combination with gemcitabine without causing severe side effects
* To learn what kind of side effects nab-paclitaxel given in combination with gemcitabine can cause
* To learn more about the pharmacology (how the body handles the drug) of nab-paclitaxel given in combination with gemcitabine
* To evaluate tumor tissue for levels of certain proteins that may help with predicting who will benefit most from treatment with nab-paclitaxel
* To determine whether nab-paclitaxel given in combination with gemcitabine is a beneficial treatment for relapsed and/or refractory solid tumors

Relapsed and refractory non-central nervous system (non-CNS) solid tumors have poor outcomes, and novel therapies are needed. Many relapsed/refractory solid tumor patients desire further therapy; however, they often wish to also preserve a high quality of life. Thus therapeutic strategies that offer relatively minimal treatment-related toxicities are also desirable. The combination of gemcitabine, a pyrimidine analog, and docetaxel, an antimitotic taxane, is an attractive combination because of non-overlapping toxicities. This combination has shown activity and tolerability in adult Phase II trials for solid tumors. Favorable experiences with this regimen in pediatrics have been described retrospectively by several institutions. Nab-paclitaxel is an albumin-bound, solvent-free taxane that allows higher dosing and shorter infusion duration than solvent-bound taxanes (docetaxel and paclitaxel) by removing exposure to toxic solvent carriers. Albumin binding of the agent also increases drug delivery to tumors through increased albumin-initiated transcytosis, and may also increase tumoral accumulation of drug through binding of secreted protein acidic and rich in cysteine (SPARC). The combination of gemcitabine and nab-paclitaxel has been studied extensively in adults with pancreatic adenocarcinoma, with the combination providing superior outcomes to treatment with gemcitabine alone. There is also preclinical evidence of potent anti-tumor activity of nab-paclitaxel alone and in combination with gemcitabine in pediatric solid tumor models. Therefore, the researchers hypothesize that the combination of nab-paclitaxel with gemcitabine will improve the anti-tumor efficacy observed with gemcitabine/docetaxel in relapsed/refractory solid tumors.

This is a Phase 1 study of nab-paclitaxel in combination with gemcitabine for children, adolescents, and young adults with relapsed or refractory non-central nervous system (CNS) solid tumors in which the researchers will define toxicity, pharmacokinetics, and evaluate SPARC expression in pediatric tumors as a biomarker of disease response.

Nab-paclitaxel will be administered intravenously (IV) once weekly on days 1,8, and 15 of a 28 day cycle. The starting dose of nab-paclitaxel will be 180 mg/m2/dose which is 75% of the pediatric, single agent MTD of 240 mg/m2/dose. The researchers will then dose escalate up to 240 mg/m2/dose. Dose Level 1 of the protocol prior to Amendment 2 utilized nab-paclitaxel at 180 mg/m2/dose and gemcitabine and 1000 mg/m2/dose given on days 1, 8, and 15 of 28 day cycles. The study enrolled 5 patients at Dose Level 1 and two patients experienced hematologic dose limiting toxicities (DLTs). Amendment 2 decreases the starting dose of gemcitabine on Dose Level 1 to 675 mg/m2/dose on days 1, 8, and 15 of the 28 day cycle. If Dose Level 1 is tolerated, then the dose of nab-paclitaxel will escalated on subsequent dose levels. If two or more participants experience DLTs at Dose Level 1, then the study will de-escalate to Dose Level 0 by decreasing the gemcitabine dose to 500 mg/m2/dose IV days 1, 8, and 15. If Dose Level 0 is tolerated, then a dose escalation of nab-paclitaxel will occur.

Participants may continue on therapy until there is evidence of progressive disease or toxicity that requires removal from therapy. Therapy may otherwise continue for up to 24 cycles.

Nab-paclitaxel in Combination With Gemcitabine for Pediatric Relapsed and Refractory Solid Tumors

AflacST1603: A Phase 1 Study Using Nab-paclitaxel (Abraxane®) in Combination With Gemcitabine for Pediatric Relapsed and Refractory Solid Tumors

The maximum tolerated dose (MTD) of nab-paclitaxel administered intravenously weekly every 3 of 4 weeks in combination with gemcitabine in children with refractory/relapsed non-CNS solid tumors will be determined. The MTD is empirically defined as the highest dose level at which there is no more than one patient experiencing a dose-limiting toxicity (DLT) and the next higher dose level has been determined to be too toxic. The MTD will be determined during Cycle 1 (each cycle is 28 days)

The toxicities of nab-paclitaxel in combination with gemcitabine administered intravenously weekly every 3 of 4 weeks will be determined. All toxicities observed will be summarized in terms of type (organ affected or laboratory determination), severity (by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0), and attribution. Data on toxicities will be collected during the entire time a participant is in the study (up to 24 cycles, each cycle is 28 days).

The antitumor activity (tumor growth) of nab-paclitaxel in combination with gemcitabine will be preliminarily defined, within the confines of a Phase 1 study.

The expression of SPARC in tumor tissue from pediatric solid tumors will be evaluated. Archived tumor samples obtained as part of routine subject care will be evaluated for immunohistochemical expression of SPARC. Samples will be evaluated from all surgical procedures to evaluate if expression of these factors changes over time and can predict tumor responsiveness to therapy. Specifically, samples from diagnosis, post-therapy resection, and relapse (when performed for clinical reasons) will be evaluated.

Blood samples will be collected for the first dose (Cycle 1, Day 1) from all patients on study to analyze paclitaxel concentrations in blood. Blood samples will be obtained on Day 1 of Cycle 1 at 1-2 min prior to end of infusion, and 0.25, 1, 3, 5, 7, 24, and 48 hours after end of the nab-paclitaxel infusion.

Celgene Corporation

Emory University

Associate Professor

Participants in the experimental arm (i.e., physical activity) will be asked to complete the 12-week home-based physical activity program and to complete all study assessments.

Participants in the no intervention arm (i.e., wait-list control) will be asked to maintain their usual lifestyle activities and to complete all study assessments. Participants in this arm will be provided with the 12-week home-based physical activity program in the exact same way as participants in the experimental arm (i.e., physical activity) at the end of the study.

Participants will receive a 12-week home-based physical activity program that has been individualized using their baseline assessment results. The program will be comprised of aerobic training (2 days/week) and resistance training (2 days/week). The aerobic training will be performed unsupervised. The resistance training will be performed under the supervision of a study team member (who will visit participants homes) for the first 6 weeks to ensure proper form and safety.

Physical Activity

Jennifer Brunet, PhD

More adolescents and young adults are surviving cancer than ever before. Many endure negative effects related to their cancer and its treatment, which reduces their quality of life and functioning. Physical activity is one strategy that has been shown to promote quality of life amongst cancer survivors. However, very little research has focused on adolescent and young adult cancer survivors. Therefore, the purpose of this pilot randomized controlled trial is to explore the feasibility, safety, and potential benefits of a 12-week home-based physical activity intervention in adolescent and young adult cancer survivors.

Physical Activity for Adolescent and Young Adult Cancer Survivors

Exploring the Feasibility, Safety, and Potential Benefits of a 12-week Home-based Physical Activity Intervention

Change in participants responses to a single open-ended question: "Do you ever feel like you have a hard time thinking and/or remembering?" from baseline, to post-intervention, to follow-up.

NOTE: Once recruited to the main trial, participants will have the option to participate in additional assessments testing cognitive functioning. If interested, participants must meet additional inclusion/exclusion criteria for the additional assessments.

Change in participants cognitive functioning, as assessed by a structural scan, a resting state functional MRI (fMRI) procedure, four fMRI tasks, and a diffusion tensor imaging sequence (lasting approximately 60 minutes), from baseline, to post-intervention, to follow-up.

NOTE: Once recruited to the main trial, participants will have the option to participate in additional assessments testing cognitive functioning. If interested, participants must meet additional inclusion/exclusion criteria for the additional assessments.

The socio-demographic and medical information collected will be used to describe the sample.

The number of eligible participants who enrol in the study out of the number who are referred.

The number of participants completing the intervention and all scheduled assessments.

The number of physical activity sessions engaged in out of the total recommended as part of the intervention.

The number of participants reporting or presenting adverse events (e.g., injury) that occurs as a result of participating in the physical activity intervention and/or its assessments.

Change in daily self-reported daily physical activity from baseline, to mid-intervention, to post-intervention, to follow-up (if applicable; i.e., if participant consents and is eligible to participate in the additional assessments testing cognitive functioning).

Change in self-reported physical activity (over the past 7 days) from baseline, to mid-intervention, to post-intervention, to follow-up (if applicable; i.e., if participant consents and is eligible to participate in the additional assessments testing cognitive functioning).

Change in objective levels of physical activity as measured by accelerometers (Actigraph wGT3XP-BT), which will be worn for a 7 day period from baseline, to mid-intervention, to post-intervention, to follow-up (if applicable; i.e., if participant consents and is eligible to participate in the additional assessments testing cognitive functioning).

Change in resting heart rate, as measured by a heart rate monitor (Polar A300), from baseline, to mid-intervention, to post-intervention.

Change in resting blood pressure, using a blood pressure monitor (HealthSmart Digital Blood Pressure Monitor), from baseline, to mid-intervention, to post-intervention.

Change in body mass as determined by a Tanita scale (TBF-310 GS) that uses bioelectrical impedance to assess body composition from baseline, to mid-intervention, to post-intervention.

Change in aerobic capacity (i.e., total distance walked in 6 minutes) from baseline, to mid-intervention, to post-intervention.

Change in musculoskeletal strength (i.e., force exerted in kilograms on the handheld dynamometer) from baseline, to mid-intervention, to post-intervention.

Change in muscular endurance (i.e., number of times participants can stand from a seated position in 30 seconds) from baseline, to mid-intervention, to post-intervention.

Change in participants self-reported self-efficacy from baseline, to mid-intervention, to post-intervention.

Change in participants self-reported physical competence and physical self-esteem from baseline, to mid-intervention, to post-intervention.

Change in participants self-reported global self-esteem from baseline, to mid-intervention, to post-intervention.

Change in participants self-reported body image from baseline, to mid-intervention, to post-intervention.

Change in participants self-reported posttraumatic growth from baseline, to mid-intervention, to post-intervention.

Change in participants self-reported quality of life from baseline, to mid-intervention, to post-intervention.

Participants experiences in the intervention (i.e., with physical activity if in the experimental arm or with engaging in their usual lifestyle if in the wait-list control arm) and subsequent changes, if any, in behavioural, physical, psychological, and quality of life outcomes as explored via qualitative interviews (following an interview schedule containing a series of open-ended questions and probes) from baseline to post-intervention.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Implementation of a Program Based on Adapted Physical Activity and Recommendations for Second Cancers Prevention for TYACs	NCT03336905	Neoplasms	Physical activi...	15 Years - 25 Years	Centre Leon Berard
Measuring Health Related Quality of Life in AYAs	NCT03482778	Oncology Quality of Life		15 Years - 39 Years	Wake Forest University Health Sciences
UNC Childhood, Adolescent, and Young Adult Cancer Cohort	NCT05096923	Pediatric Cance... Cancer Cancer Metastat... Survivorship		1 Year - 39 Years	UNC Lineberger Comprehensive Cancer Center
Yoga for Adolescent and Young Adult Non-Curative Cancer Patients	NCT01901237	Advanced Cancer	Hatha Yoga	15 Years - 39 Years	Nova Scotia Health Authority
mHealth Physical Activity Intervention for Survivors of Adolescent and Young Adult Cancers	NCT03386383	Cancer Physical Activi...	Intervention	18 Years - 39 Years	UNC Lineberger Comprehensive Cancer Center
Nab-paclitaxel in Combination With Gemcitabine for Pediatric Relapsed and Refractory Solid Tumors	NCT03507491	Cancer	Gemcitabine Nab-paclitaxel	6 Months - 30 Years	Emory University
Physical Activity for Adolescent and Young Adult Cancer Survivors	NCT03016728	Adolescent and ...	Physical Activi...	15 Years - 44 Years	University of Ottawa
mHealth Physical Activity Intervention for Survivors of Adolescent and Young Adult Cancers	NCT03386383	Cancer Physical Activi...	Intervention	18 Years - 39 Years	UNC Lineberger Comprehensive Cancer Center
UNC Childhood, Adolescent, and Young Adult Cancer Cohort	NCT05096923	Pediatric Cance... Cancer Cancer Metastat... Survivorship		1 Year - 39 Years	UNC Lineberger Comprehensive Cancer Center

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