Phase II Study of Everolimus in Children and Adolescents With Refractory or Relapsed Osteosarcoma
Verified August 2013 by Hospital Santa Marcelina
Information provided by (Responsible Party):
Sidnei Epelman, Hospital Santa Marcelina
First received: October 4, 2010
Last updated: August 5, 2013
Last verified: August 2013
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.
Refractory or Relapsed Osteosarcoma
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Phase II Study of Everolimus in Children and Adolescents With Refractory or Relapsed Osteosarcoma
Primary Outcome Measures:
- Determine the Everolimus aim response in children and adolescents with refractory or relapsed osteosarcoma [ Time Frame: Up to 2 years. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Define Everolimus toxicity in this population [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||June 2014 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||up to 21 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01216826
|Hospital Santa Marcelina
|Sao Paulo, SP, Brazil, 08270070 |
|Contact: Sidnei Epelman, MD +55 11 2522-2472 email@example.com |
||Sidnei Epelman, MD
||Hospital Santa Marcelina
No publications provided
||Sidnei Epelman, Director of Pediatric Oncology Department, Hospital Santa Marcelina
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 4, 2010
||August 5, 2013
||Brazil: Ethics Committee
Brazil: Ministry of Health
Brazil: National Committee of Ethics in Research
Brazil: National Health Surveillance Agency
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 22, 2014
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Physiological Effects of Drugs