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

This study is currently recruiting participants.
Verified August 2013 by Hospital Santa Marcelina
Sponsor:
Information provided by (Responsible Party):
Sidnei Epelman, Hospital Santa Marcelina
ClinicalTrials.gov Identifier:
NCT01216826
First received: October 4, 2010
Last updated: August 5, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Refractory or Relapsed Osteosarcoma
Drug: Everolimus
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Everolimus in Children and Adolescents With Refractory or Relapsed Osteosarcoma

Resource links provided by NLM:


Further study details as provided by Hospital Santa Marcelina:

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: 20
Study Start Date: March 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01216826

Locations
Brazil
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
Investigators
Principal Investigator: Sidnei Epelman, MD Hospital Santa Marcelina
  More Information

No publications provided

Responsible Party: Sidnei Epelman, Director of Pediatric Oncology Department, Hospital Santa Marcelina
ClinicalTrials.gov Identifier: NCT01216826     History of Changes
Other Study ID Numbers: CRAD001CBR07T
Study First Received: October 4, 2010
Last Updated: August 5, 2013
Health Authority: Brazil: Ethics Committee
Brazil: Ministry of Health
Brazil: National Committee of Ethics in Research
Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on April 16, 2014