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

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ClinicalTrials.gov Identifier: NCT01216826
Recruitment Status : Unknown
Verified August 2013 by Sidnei Epelman, Hospital Santa Marcelina.
Recruitment status was:  Recruiting
First Posted : October 7, 2010
Last Update Posted : August 7, 2013
Information provided by (Responsible Party):
Sidnei Epelman, Hospital Santa Marcelina

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.

Condition or disease Intervention/treatment Phase
Refractory or Relapsed Osteosarcoma Drug: Everolimus Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Everolimus in Children and Adolescents With Refractory or Relapsed Osteosarcoma
Study Start Date : March 2011
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Everolimus Drug: Everolimus
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.
Other Name: Afinitor, RAD.

Primary Outcome Measures :
  1. Determine the Everolimus aim response in children and adolescents with refractory or relapsed osteosarcoma [ Time Frame: Up to 2 years. ]

Secondary Outcome Measures :
  1. Define Everolimus toxicity in this population [ Time Frame: Up to 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  • Patient with hemorrhagic disorder or using oral anti-vitamin K (except warfarin in low doses).
  • Patient with HIV infection.
  • Incapable to perform protocol visits.
  • Another neoplasia for the last 2 years (except squamous or basocellular skin cancer).
  • Hypersensitivity history to rapamycin analogs.
  • Chronic treatment with corticoids (except per oral, topical or local treatment) or another immunosuppressor agent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01216826

Hospital Santa Marcelina Recruiting
Sao Paulo, SP, Brazil, 08270070
Contact: Sidnei Epelman, MD    +55 11 2522-2472    epelman@inctrbrasil.org   
Sponsors and Collaborators
Sidnei Epelman
Principal Investigator: Sidnei Epelman, MD Hospital Santa Marcelina

Responsible Party: Sidnei Epelman, Director of Pediatric Oncology Department, Hospital Santa Marcelina
ClinicalTrials.gov Identifier: NCT01216826     History of Changes
Other Study ID Numbers: CRAD001CBR07T
First Posted: October 7, 2010    Key Record Dates
Last Update Posted: August 7, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents