Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Osteosarcoma

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Sarcoma

Soft Tissue Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Etoposide

Ifosfamide

Etoposide phosphate

Tyrosine Kinase Inhibitors

Isophosphamide mustard

Mechlorethamine

Enzyme Inhibitors

Antineoplastic Agents, Alkylating

Alkylating Agents

Tyrosine

Children and adolescents with relapsed or refractory drug resistant osteosarcoma

(1) Sulfatinib: 300 mg, oral once a day (QD), 21 days as a cycle

Sulfatinib

(1) Etoposide: 100 mg/m2/day (initial dose) will be administered on the first to third days of each 21 day cycle, a total of 5 cycles. The dose of etoposide can be reduced to 80 mg/m2/day and 60 mg/m2/day.;

(1) Isophosphamide: 3000 mg/m2/day (initial dose) will be administered on the first to third days of each 21 day cycle for 5 cycles. The dose of ifosfamide can be reduced to 2400 mg/m2/day and 1800 mg/m2/day.

Isophosphamide

Zhaoming Ye, PhD

zengjie zhang, MD

Yi Yang, PhD

Zhenfeng Li, PhD

Weibin Zhang, PhD

Sung Taek Jung, PhD

zhaoming Ye, PhD

Binhao Li, PhD

Shengdong Wang, MD

Xin Huang, PhD

Peng Lin, MD

This is a phase 1/2 study evaluating safety, tolerability, and efficacy of Sulfatinib in combination with chemotherapy (ifosfamide and etoposide) in children and adolescents with refractory or relapsed osteosarcoma ( combination Sulfatinib).

The study consists of 2 cohorts:

Cohort 1 (Traditional chemotherapy) will evaluate the efficacy of ifosfamide and etoposide in children, adolescents, and young adults with relapsed or refractory osteosarcoma.

Cohort 2 (Combination Expansion) will evaluate the efficacy of Sulfatinib in combination with ifosfamide and etoposide in children, adolescents, and young adults with relapsed or refractory osteosarcoma.

Sulfatinib will be provided as hard capsules containing 300 mg Sulfatinib. Sulfatinib capsules should be dissolved in water or apple juice for those who are unable to swallow capsules.

A Study of Sulfatinib on Relapsed or Refractory Drug Resistant Osteosarcoma

A Study of Etoposide and Ifosfamide Combined With or Without Sulfatinib on Relapsed or Refractory Drug Resistant Osteosarcoma

The proportion of patients who had no objective tumor progression or death from the start of treatment to 4 months of follow-up.

Complete response (CR), all target and non-target lesions (non-lymph nodes) disappear, and the diameter of all pathologic lymph nodes (both target and non-target) must be reduced to \<10 mm; Partial response (PR), using baseline total diameter as reference, reduced the total diameter of target lesions by at least 30%.

From the date of the first administration of the study drug to disease progression or death, whichever occurs first.

Complete response (CR)/ partial response (PR) was first recorded until disease progression was first recorded until the data cutoff date.

Chonnam National University

Peking University People's Hospital

Qilu Hospital of Shandong University

Ruijin Hospital

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Second Affiliated Hospital, School of Medicine, Zhejiang University

Anti-Infective Agents

Everolimus

Sirolimus

Temsirolimus

MTOR Inhibitors

Protein Kinase Inhibitors

Immunosuppressive Agents

Immunologic Factors

Everolimus will be administered every day, initial dose 5 mg/m²/dia, in 28 days cycles. Maximum dosis: 10 mg/day. The cycles will be repeated till progression disease or untolerable toxicity.

Sidnei Epelman, MD

The purpose of this study is to determine the Everolimus aim response in children and adolescents with refractory or relapsed osteosarcoma.

The aim response is defined as complete or partial response (according to RECIST criteria) for at least 4 weeks, or stable disease for at least 12 weeks.

Phase II Study of Everolimus in Children and Adolescents With Refractory or Relapsed Osteosarcoma

Sidnei Epelman

Director of Pediatric Oncology Department

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Sulfatinib on Relapsed or Refractory Drug Resistant Osteosarcoma	NCT05590572	Osteosarcoma	Sulfatinib Etoposide Isophosphamide	2 Years - 25 Years	Second Affiliated Hospital, School of Medicine, Zhejiang University
A Study of Sulfatinib on Relapsed or Refractory Drug Resistant Osteosarcoma	NCT05590572	Osteosarcoma	Sulfatinib Etoposide Isophosphamide	2 Years - 25 Years	Second Affiliated Hospital, School of Medicine, Zhejiang University
Phase II Study of Everolimus in Children and Adolescents With Refractory or Relapsed Osteosarcoma	NCT01216826	Refractory or R...	Everolimus	- 21 Years	Hospital Santa Marcelina
Phase II Study of Everolimus in Children and Adolescents With Refractory or Relapsed Osteosarcoma	NCT01216826	Refractory or R...	Everolimus	- 21 Years	Hospital Santa Marcelina

Spots Global Cancer Trial Database for refractory or relapsed osteosarcoma