Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Nutritional and Metabolic Diseases

Symptoms and General Pathology

Rare Diseases

Lymphoma

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Obesity

Vitamin D Deficiency

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Avitaminosis

Deficiency Diseases

Malnutrition

Nutrition Disorders

Lymphosarcoma

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

Bone Density Conservation Agents

Micronutrients

All Drugs and Chemicals

Anticoagulants

Gastrointestinal Agents

Vasoconstrictor Agents

Other Dietary Supplements

Vitamins

Vitamin D

Cholecalciferol

Calcium

Citric Acid

Sodium Citrate

Calcium Carbonate

Calcium, Dietary

Calcitriol

Dihydroxycholecalciferols

Trace Elements

Hormones

Antacids

Anti-Ulcer Agents

Citrate

Vitamin D3

Calciferol

Vitamin D (10,000 int.units/ml) 100,000 int. units (10ml) by mouth once every two months x 3 times (total treatment period approximately 6-7 months)

Calcium Carbonate (1,000 mg/tab = 400 mg elemental calcium/tab) 2,000 mg (2 chewable tabs) by mouth every day for approximately 6-7 months

Vitamin D and Calcium Citrate

Etan Orgel, MD

Steven Mittelman, MD, PhD

Many adolescents with acute lymphoblastic leukemia (ALL) have been found to have low bone density by the end of treatment. This can lead to long-term suffering in survivors due to poor bone health. Vitamin D is known to be associated with bone health and previous research has established that Vitamin D insufficiency is very common at diagnosis of ALL and worsens over the course of treatment. Researchers have also learned that a relationship exists between both Vitamin D and fat tissue and ALL and fat tissue.

In adolescents being treated for ALL as well as in early survivors, this randomized study will therefore examine the effect of Vitamin D and calcium supplementation on correcting Vitamin D insufficiency and on improving bone density in the context of changes in body composition and body fat. Bone density will be measured by a radiology exam called qCT (quantitative computed tomography) while body composition and body fat will be measured by a different radiology exam called a DXA (dual energy x-ray absorptiometry scan) . The study will also examine in depth the relationship between these three elements - Vitamin D insufficiency, obesity, and ALL - and their impact on bone density.

Nutrition and Body Composition in Acute Lymphoblastic Leukemia

Nutrition and Body Composition in Acute Lymphoblastic Leukemia (Environment and Microenvironment in ALL #2)

Change in Vitamin D levels from baseline to study end (Group A: Consolidation through end of Delayed Intensification)

Bone mineral density (vBMD) at end of study period (Group A: end of Delayed Intensification)

Change in serum vitamin D level was assessed in survivors at baseline and after 6 months of supplementation

Bone mineral density (vBMD) at end of study period (Group B: after 6 months)

Insufficiency defined as 25(OH)D \< 30 ng/ml

The Leukemia and Lymphoma Society

Children's Hospital Los Angeles

Clinical Fellow

Note that subjects in the On-Therapy "natural history" arm (i.e. Group A, not randomized) were not formally followed for adverse event reporting.

Subjects in Sibling group (Arm C) had a single visit for a laboratory draw with no adverse event reporting indicated.

Subjects randomized following Induction to receive education plus:

Vitamin D and Calcium Citrate: Vitamin D (10,000 int.units/ml) 100,000 int. units (10ml) by mouth once every two months x 3 times (total treatment period approximately 6 months) Calcium Carbonate (1,000 mg/tab = 400 mg elemental calcium/tab) 2,000 mg (2 chewable tabs) by mouth every day through study period (total treatment period approximately 6 months)

On Therapy Intervention (Group A)

Subjects randomized following Induction to receive standard of care with education alone

On Therapy Standard of Care (Group A)

Survivors randomized to receive directly-observed therapy with open-label Vitamin and chewable calcium

Survivorship Intervention (Group B)

Survivors randomized to receive standard of care with education alone OR ineligible for open-label Vitamin D+Calcium randomization

Survivorship Standard of Care (Group B)

Singling of Group A were enrolled for a one-time visit for labs; All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed.

Siblings of Group A (Group C)

Subjects randomized following Induction to receive education plus:

Vitamin D and Calcium Citrate: Vitamin D (10,000 int.units/ml) 100,000 int. units (10ml) by mouth once every two months x 3 times (total treatment period approximately 6-7 months) Calcium Carbonate (1,000 mg/tab = 400 mg elemental calcium/tab) 2,000 mg (2 chewable tabs) by mouth every day through study period (total treatment period approximately 6-7 months)P

Subjects surviving to end of Induction but ineligible for randomization for any reason

On Therapy "Natural History" (Group A)

Survivors to receive education plus:

Vitamin D and Calcium Citrate: Vitamin D (10,000 int.units/ml) 100,000 int. units (10ml) by mouth once every two months x 3 times (total treatment period approximately 6 months) Calcium Carbonate (1,000 mg/tab = 400 mg elemental calcium/tab) 2,000 mg (2 chewable tabs) by mouth every day through study period (total treatment period approximately 6 months)

Survivors either randomized to received standard of care with education alone OR vitamin D sufficient and continued for follow-up only.

Siblings (Group C)

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

United States

Region of Enrollment

Dr. Etan Orgel

Change in serum Vitamin 25(OH)D level

Post-intervention serum Vitamin 25(OH)D level

On-Therapy Intervention (Group A)

Subjects randomized following Induction to receive standard of care with education alone OR subjects ineligible for open-label randomization and followed as "natural history" cohort.

Patients enrolled prior to open-label randomization and those not eligible for randomization at end of induction

On-Therapy "Natural History" (Group A)

Includes subjects in each group evaluable for vitamin D endpoint. Calculation of change = Vitamin D level at study end (end of DI, \~+6 months)/Vitamin D level at baseline (start of consolidation).

Change in Serum Vitamin D Level (Group A)

Cortical BMD

Cancellous BMD

On-Therapy "Natural History" (Group A, Tibia)

Subjects enrolled following the change to the open-label randomization were imaged for cortical bone density at the femur, subjects enrolled prior to this in the Natural History group were imaged at the tibia. The change was made for later subjects due to technical reasons to provide a better estimate of cortical density.

Bone Mineral Density by Quantitative Computed Tomography (QCT) at Study End (Group A)

Subjects randomized to receive education plus directly-observed therapy with open-label Vitamin D and chewable calcium

Survivors randomized to receive standard of care with education alone OR subjects ineligible for open-label Vitamin D+ Calcium randomization and continued with follow-up only.

Change in Vitamin D = Vitamin D at +6months/Vitamin D at baseline

Change in Vitamin D Level (Group B)

Cortical bone mineral density

Cancellous bone mineral density

Bone Mineral Density by QCT in Survivors at Study End (Group B)

Healthy siblings of survivors of pediatric ALL for one-time assessment

Siblings of Survivors (Group C)

Newly Diagnosed Patients (Group A)

Group C: Only four siblings enrolled and arm closed early due to poor accrual. Specimens from this group were not analyzed so no results are available.

Group A: 39 subjects enrolled at diagnosis had Vitamin D testing performed at diagnosis and had results available.

Prevalence of Obesity and Vitamin D Insufficiency in Adolescents With Newly Diagnosed ALL and in Their Siblings

Healthy siblings of survivors of pediatric acute lymphoblastic leukemia (ALL) for one-time assessment

Overall Study

Respiratory Tract (Lung and Bronchial) Diseases

Nervous System Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Anorexia

Muscular Atrophy

Wasting Syndrome

Cachexia

Syndrome

Weight Loss

Body Weight

Body Weight Changes

Thinness

Metabolic Diseases

Level 0: Ruxolitinib 0 MG po bid for 1 month (Month 1)

Level 1: Ruxolitinib 10 MG po bid for 1 month (Month 2)

Level 2: Ruxolitinib 15 MG po bid for 1 month (Month 3)

There will be intra-patient dose escalation of ruxolitinib in every patient enrolled on study.

Identify any dose-limiting toxicity (DLT) when ruxolitinib is administered to NSCLC cachexia patients.

Sarah Neufeld

Tu Dan, MD

To assess toxicity with use of Ruxolitinib in NSCLC cachexia patients; to associate levels of JAK/STAT signaling in blood, adipose, and muscle pre- and post-ruxolitinib treatment with changes in cachexia and anorexia.

Lung cancer patients on a whole, and a significant percentage of NSCLC patients in particular, develop cancer cachexia. In fact, approximately 30-40% of all NSCLC patients will develop cachexia in their disease course, with the highest percentages in stage IV patients. One-third of these patients will die of cachexia-related morbidity. In these groups, stage-matched NSCLC patients with cachexia will have poorer survival than those without cachexia.

The JAK 1/2 inhibitor ruxolitinib has been used in many types of non-oncologic and oncologic patients with a well-established toxicity profile. Ruxolitinib was created as an oral agent with the capacity to antagonize JAK/STAT signaling across cell types. Based on the findings of the REACH2 and REACH3 trials, a starting dose of 10 mg twice daily oral administration of ruxolitinib was established for the latter patient population and is also a starting dose for the polycythemia patients. Known but manageable side effects of ruxolitinib use include thrombocytopenia, anemia, neutropenia, risk of infection, among other conditions.

Ruxolitinib has not specifically been used in 1) cancer cachexia patient populations in an evaluable trial or 2) in the setting of first line cancer therapies for solid tumors who are receiving new standards of care including immunotherapy (IO). Therefore, in this trial, investigators propose using ruxolitinib in an open-label approach to antagonize systemic and tissue-specific, tumor-directed JAK/STAT signaling as a means curtailing cachexia progression in stage IV NSCLC patients. This study will ensure an acceptable toxicity profile when ruxolitinib is used in cancer cachexia patients.The use of ruxolitinib dose escalation in the same patients with frequent tissue and serum collections will permit us to better understand how important JAK/STAT signaling is to clinical cancer cachexia development.

Open label, single arm, pilot study, Intrapatient dose escalation

Ruxolitinib for Cancer Cachexia

Pilot Study of Ruxolitinib in the Treatment of Cancer Cachexia

To assess toxicity with use of Ruxolitinib in NSCLC (non-small cell lung cancer) cachexia patients; to associate levels of JAK/STAT (Janus kinase-signal transducer and activator of transcription) signaling in blood, adipose, and muscle pre- and post-ruxolitinib treatment with changes in cachexia and anorexia. NCI's CTCAE v5.0 toxicity criteria will be used to measure Ruxolitinib-related side effects. Immunoblotting, FACS analyses, and other biologic metrics will be used to determine if Ruxolitinib can suppress cachexia-associated JAK/STAT activation in blood and peripheral tissues.

For the secondary objective of adverse events, investigator will again use NCI's CTCAE v5.0 toxicity criteria throughout the trial evaluation.

Patient tumor response will be determined by CT-based imaging (CT, PET/CT), MRI (brain evaluation), and other clinical indicators (bronchoscopy, image-guided biopsies), etc. with RECIST and iRECIST criteria response criteria as a function of Ruxolitinib use and dose. In patients with measurable disease, to describe any preliminary evidence of Ruxolitinib's anti-tumor activity by assessment of objective response as determined by RECIST in cancer cachexia patients. Two such measurements will be conducted during the course of the trial.

Quality of life questionnaire while on ruxolitinib will be assessed with the EORTC QLQ-CAX24 (The European Organization for Research and Treatment of Cancer quality of life questionnaire). Questionnaire will be given to patients every 2 weeks for 3 months while on study and 1 month of follow-up.

Body weight will be measured every 2 weeks while on study, including 1 month of follow-up. Both DEXA (dual-energy x-ray absorptiometry) imaging every 2 weeks while on study/follow-up and CT-based imaging with auto-segmentation will provide measures of how Ruxolitinib may be suppressing cachexia-associated adipose and muscle loss.

Anorexia will be assessed with the EORTC QLQ-CAX24 questionnaire as well as direct clinical history taking every 2 weeks on study. Descriptive statistics will be used to report changes.

Progression-free survival (CT-based imaging) will be assessed for all patients while on and off Ruxolitinib. There will be one determination of OS at 6 months from start of active phase of study. Estimates will be descriptively presented using the Kaplan-Meier method.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Nutrition and Body Composition in Acute Lymphoblastic Leukemia	NCT01317940	Precursor Cell ... Vitamin D Defic...	Vitamin D and C...	10 Years - 29 Years	Children's Hospital Los Angeles
Nutrition and Body Composition in Acute Lymphoblastic Leukemia	NCT01317940	Precursor Cell ... Vitamin D Defic...	Vitamin D and C...	10 Years - 29 Years	Children's Hospital Los Angeles
Ruxolitinib for Cancer Cachexia	NCT04906746	Stage IV Non-sm... Cachexia	Identify any do...	18 Years -	University of Texas Southwestern Medical Center
Ruxolitinib for Cancer Cachexia	NCT04906746	Stage IV Non-sm... Cachexia	Identify any do...	18 Years -	University of Texas Southwestern Medical Center
Ruxolitinib for Cancer Cachexia	NCT04906746	Stage IV Non-sm... Cachexia	Identify any do...	18 Years -	University of Texas Southwestern Medical Center

Spots Global Cancer Trial Database for adipose

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

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