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

NCT01216826 | Unknown Phase 2

• 1 other identifier: CRAD001CBR07T
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Refractory or Relapsed Osteosarcoma

Outcome Measures

Primary Outcomes (1)

• Determine the Everolimus aim response in children and adolescents with refractory or relapsed osteosarcoma

  Up to 2 years.

Secondary Outcomes (1)

• Define Everolimus toxicity in this population

  Up to 2 years

Study Arms (1)

Everolimus

EXPERIMENTAL

Drug: Everolimus

Interventions

Everolimus DRUG

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.

Also known as: Afinitor, RAD.

Everolimus

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Osteosarcoma histological confirmation.
• No option of known curative treatment, neither approved treatment that increases survival with adequate quality of life.
• Karnofsky scale ≥ 50 for patients over 16 years and Lansky scale ≥ 50 for patients under 16 years.
• Subjects should not have received antineoplastic therapy \< 4 weeks before study treatment initiation.
• Adequate hematological function: neutrophil count \> 1.500/mm³, platelets \> 100.000/mm³ and hemoglobin \> 8.0 mg/dL.
• Adequate renal function, as defined below:
• Age Maximum serum creatinine (mg/dL) 0 - 29 days 0,4 - 0,7 1 month - 3 years 0,7 4 - 7 years 0,8 8 - 10 years 0,9 11 - 12 years 1,0 13 - 17 years 1,2
• ≥18 years 1,3
• Adequate hepatic function: total bilirubin ≤ 1.5 x ULN and transaminases ≤ 2.5 x ULN.
• Patient and/or legal responsible must sign ICF.
• Life expectation \> 8 weeks.
• Measurable disease, according to RECIST criteria.
• For female patients of childbearing age: Presence of a negative pregnancy test within 7 days prior to day 0.
• The patient agrees to use effective contraception if procreative potential exists. Use of reliable means of contraception (e.g. hormonal contraceptive, patch, vaginal ring, intrauterine device, physical barrier, abstinence) for subjects of reproductive potential (males and females) is required during study treatment and for 3 months following last dose of study drug

You may not qualify if:

• History of myocardial infarction, angina or cerebrovascular accident related to atherosclerosis.
• Pulmonary disorder (e.g. FEV1 or DLCO ≤ 70% upper expected).
• Significant hematologic or hepatic abnormality (transaminases levels \> 2.5 x ULN or serum bilirubin \>1.5 x ULN, hemoglobin \< 8 g/dL, platelets \< 100.000/ mm3, ANC \< 1.500/mm3).
• Has other existing serious medical conditions that could adversely affect the ability of the patient to be treated in accordance with the protocol.
• Any condition, therapy, or medical condition, which, in the opinion of the attending physician could represent a risk for the patient or adversely affect the study objectives.
• If female, is pregnant or lactating.
• Active infection at the moment of recruitment.
• Previous history of organ transplantation.
• Recent surgery \< 2 months before entering study.
• Concomitant antineoplastic therapy.
• Patient received more than one rescue treatment, previously.
• Previous treatment with mTor inhibitors (ex: sirolimus, temsirolimus, everolimus).
• Use of investigational drug \< 30 days before entering study.
• Non-controlled hyperlipidaemia: serum cholesterol (fasting) \> 300 mg/dL or 7,75 mmol/L and triglycerides (fasting) \> 2,5 x ULN.
• Non-controlled diabetes mellitus defined as: glycemia (fasting) \> 1.5 x ULN.

Sponsors & Collaborators

• Sidnei Epelman: lead

Study Sites (1)

Hospital Santa Marcelina

São Paulo, São Paulo, 08270070, Brazil

RECRUITING

MeSH Terms

Conditions

Osteosarcoma

Interventions

Everolimus

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Study Officials

• Sidnei Epelman, MD

  Hospital Santa Marcelina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Pediatric Oncology Department

Study Record Dates

• First Submitted: October 4, 2010
• First Posted: October 7, 2010
• Study Start: March 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 7, 2013

Record last verified: 2013-08

Locations

BR (1)