Symptoms and General Pathology

All Conditions

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Osteosarcoma

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Sarcoma

Soft Tissue Sarcoma

DNA and RNA extracted from biopsy samples are analyzed for methylation changes and transcription changes by ligation-mediated PCR and mass-array genotyping.

laboratory biomarker analysis

Jeremy Rosenblum, MD

This research study is studying biomarkers in predicting response to chemotherapy in samples from young patients with osteosarcoma. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

Study Subtype: Ancillary/Correlative Observational Study Model: Cohort Time Perspective: Retrospective Biospecimen Retention: Samples With DNA Biospecimen Description: Tissue Study Population Description: Children's Oncology Group Sampling Method: Non-Probability Sample

PRIMARY OBJECTIVES:

I. Determine whether methylation status predicts response to neoadjuvant chemotherapy in samples from children and young adults with osteosarcoma.

OUTLINE: Patients are stratified according to response to neoadjuvant chemotherapy (good vs poor).

DNA and RNA extracted from biopsy samples are analyzed for methylation changes and transcription changes by ligation-mediated PCR and mass-array genotyping.

Biomarkers in Predicting Response to Chemotherapy in Samples From Young Patients With Osteosarcoma

Observational - Methylation Status as Predictor of Response to Neoadjuvant Chemotherapy in Osteosarcoma

Performed on a locus-by-locus basis using Poisson regression (for count data) and/or two-group t-tests, with correction (Satterwaithe's) for unequal within-group variances.

National Cancer Institute (NCI)

Children's Oncology Group

Blood and Lymph Conditions

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Urinary Tract, Sexual Organs, and Pregnancy Conditions

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Brain Neoplasms

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Body Weight

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Vomiting

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Weight Loss

Body Weight Changes

Wilms Tumor

Medulloblastoma

Sarcoma, Ewing

Carcinosarcoma

Mixed Tumor, Mullerian

Testicular Neoplasms

Sarcoma, Endometrial Stromal

Chondrosarcoma

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Anti-Allergic Agents

Dermatologic Agents

Gastrointestinal Agents

All Drugs and Chemicals

Cyproheptadine

Histamine H1 Antagonists

Histamine

Histamine phosphate

Histamine Antagonists

Neurotransmitter Agents

Serotonin

Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.

Patients receive an oral placebo twice daily for 8 weeks.

cyproheptadine hydrochloride

placebo

Jeffrey P. Krischer, PhD

RATIONALE: Cyproheptadine hydrochloride may prevent weight loss caused by cancer or cancer treatment. It is not yet known whether cyproheptadine is more effective than a placebo in preventing weight loss in young patients receiving chemotherapy for cancer.

PURPOSE: This randomized phase III trial is studying cyproheptadine hydrochloride to see how well it works in preventing weight loss in young patients receiving chemotherapy for cancer.

OBJECTIVES:

Primary

* To determine the effect of cyproheptadine hydrochloride in the prevention of cancer- or treatment-related weight loss (defined as ≥ 5% reduction in weight from baseline measurement) in children who are initiating a course of moderately or highly emetic chemotherapy.

Secondary

* To investigate the effect of cyproheptadine HCl on the change in weight for age scores after 8 weeks of study drug administration in comparison to placebo.
* Investigate the relationship between the secondary outcome variables (prealbumin, triceps skin fold, mid-upper arm circumference, and weight loss)from baseline to end of treatment in each group (treatment and placebo) separately.

OUTLINE: This is a multicenter study. Patients are stratified according to enrolling center and steroid use with cancer treatment (yes vs no). Study agent can start anytime up to and including day 28 after the first dose of chemotherapy.

* Arm I: Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.
* Arm II: Patients receive an oral placebo twice daily for 8 weeks.

Patients undergo weight and height measurements at baseline and at each follow-up visit in weeks 4 and 8 to evaluate the effect of cyproheptadine hydrochloride and duration of response. Patients or parents complete medicine logs at each follow-up visit in weeks 4 and 8 to evaluate drug compliance and tolerance. Patients also undergo measures of nutrition; and measures of body composition, lean body mass, and fat percentage using standardized equipment and procedures for measuring triceps skin fold and mid-arm muscle circumference at baseline and at the end of the study.

Patients undergo blood sample collection at baseline and at the end of the study for biomarker studies. Samples are analyzed for pre-albumin levels.

Cyproheptadine in Preventing Weight Loss in Children Receiving Chemotherapy for Cancer

Prevention of Cancer/Treatment-Related Weight Loss in Children at High Nutritional Risk

University of South Florida

Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.

cyproheptadine hydrochloride: Given orally

Arm I Cyproheptadine Hydrochloride

Patients receive an oral placebo twice daily for 8 weeks.

placebo: Given orally

Arm II Placebo

Total

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Angelina Fink, Research Base Administrator

Participant With Weight Loss ≥ 5% at the 8- Week Assessment When Compared to Baseline

Severity of Weight Loss

Pattern of Weight in the Study Population

Overall Study

Musculoskeletal Diseases

Histiocytoma, Malignant Fibrous

Bone Neoplasms

Chondrosarcoma, Mesenchymal

Osteosarcoma, Juxtacortical

Histiocytoma

Neoplasms, Vascular Tissue

Neoplasms, Fibrous Tissue

Undifferentiated Pleomorphic Sarcoma

The Registry For Children, Adolescents And Adults With Osteosarcoma And Biologically Related Bone Sarcomas (COSS-Registry) is a non-interventional, multicentric, international, clinical and epidemiologic patient registry. The COSS-Registry collects key data on osteosarcomas or biologically related bone sarcomas. With that data collection we want to gain new scientific insights and results about this tumor disease, prognosis, surveillance and long-term effects.

Besides the data collection we would also like to foster the collection of biomaterial (tumor specimen and blood samples) for scientific research.

The stored material will be used to perform cell and molecular biological analyses to identify the causes of osteosarcoma, the prognosis and possible new treatment options.

As a starting point the donated biomaterial of registered patients will be analyzed firstly for the presence of a tumor predisposition by germline mutations.

In case of detected genetic variations that are related to the tumor disease and which may affect the patient's health and follow-up care (because of the potentially increased risk of developing other malignant tumors), affected patients will be informed and referred to genetic counseling.

Registry patients will be asked at the time of diagnosis if they wish to be informed about germline variants detected as part of the study procedures.

Osteosarcomas are rare and malignant bone tumors with an incidence of only 200-300 diagnoses in Germany each year. The biological behaviour of the tumor is not well understood yet. Treatment options and survival prognosis have not improved for the last decades.

The planned collection of treatment and follow-up data of affected patients at the COSS-Registry has the goal to gain further insights about this tumor, to improve survival rates and to identify possible germline variants in tumor predisposition genes in any patient diagnosed with OS.

It is also necessary to foster research on the genetic and molecular biological characteristics of osteosarcoma by analyzing biomaterial samples (especially tumor tissue) for example to identify new therapy targets or to evaluate the response to and the adverse effects of chemotherapy with respect to the germline alterations.

Therefore a substantial amount of biomaterial has to be gathered and stored in a biobank. Accompanying to the COSS-Registry's data collection, biological samples taken from registered patients during routine measures and which are no longer required for further treatment will be stored in the COSS-Biobank.

The biological samples collected will be used to carry out genetic tests to check for an underlying tumor predisposition by germline mutations and for a next-generation sequencing of the whole genome. The goal of this project is to prospectively characterize the germline genetics in OS patients, to increase the understanding of the impact of germline alterations on the age of manifestation of OS, to evaluate the response to and the adverse effects of chemotherapy with respect to the germline alterations and to integrate germline investigation and counselling into the routine workup of any child, adolescent or young adult diagnosed with OS registered at the COSS-Registry.

In this way, affected patients will benefit from their participation in the COSS-Registry and COSS-Biobank.

Registry For Children, Adolescents And Adults With Osteosarcoma And Biologically Related Bone Sarcomas

Registry For Children, Adolescents And Adults With Osteosarcoma And Biologically Related Bone Sarcomas (COSS-Registry)

Aims of the registry are the collection of clinical data to gain further insights about diagnosis, treatment, prognosis and risk factors of osteosarcoma and biologically related bone tumors.

Aim of the registry is to give the frame for reference diagnostics.

Aim of the registry is the collection of biomaterial.

Klinikum Kassel GmbH (COSS-Biobank)

Klinikum Stuttgart

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Biomarkers in Predicting Response to Chemotherapy in Samples From Young Patients With Osteosarcoma	NCT01374672	Localized Osteo... Metastatic Oste... Osteoblastic Os... Recurrent Osteo...	laboratory biom...	10 Years - 20 Years	Children's Oncology Group
Cyproheptadine in Preventing Weight Loss in Children Receiving Chemotherapy for Cancer	NCT01132547	Cancer	cyproheptadine ... placebo	2 Years - 21 Years	University of South Florida
Registry For Children, Adolescents And Adults With Osteosarcoma And Biologically Related Bone Sarcomas	NCT05515068	Osteosarcoma Bone Tumor Bone Sarcoma High Grade Sarc... Osteoblastic Os... Chondroblastic ... Fibroblastic Os... Conventional Os... Conventional Ce... Low Grade Centr... Osseous Sarcoma Osseous Tumor Small Cell Oste... Telangiectatic ... Undifferentiate... Parosteal Osteo... Periosteal Oste... Extraskeletal O... Recurrent Osteo... High Grade Surf... Osseous Angiosa... Osseous Fibrosa... Osseous Leiomyo... Osseous Dediffe... Osseous Mesench... Clear Cell Oste...		-	Klinikum Stuttgart

Spots Global Cancer Trial Database for osteoblastic osteosarcoma