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Clinical Trial Evaluating Metronomic Chemotherapy in Patients With Metastatic Osteosarcoma (GLATO2017)

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ClinicalTrials.gov Identifier: NCT03063983
Recruitment Status : Recruiting
First Posted : February 24, 2017
Last Update Posted : March 13, 2017
Sponsor:
Information provided by (Responsible Party):
Antônio Sérgio Petrilli, Grupo de Apoio ao Adolescente e a Crianca com Cancer

Brief Summary:
Preclinical models show that a daily antiangiogenic regimen at low-dose may be effective against chemotherapy-resistant tumors. The aim of this study is to evaluate the efficacy of maintenance therapy with continuous oral cyclophosphamide and methotrexate in patients with high grade, operable, metastatic osteosarcoma (OST) of the extremities. The primary end point is event-free survival (EFS) from randomization

Condition or disease Intervention/treatment Phase
Osteosarcoma Drug: Cyclophosphamide Drug: Methotrexate Phase 2

Detailed Description:
The study design includes backbone of 10 weeks of preoperative therapy using MAP (high-dose methotrexate, cisplatin, doxorubicin and dexrazoxane). Metastatic patients were randomized to high-dose chemotherapy for 31 weeks (arm 1) or concomitant metronomic therapy (MTX plus cyclophosphamide) such as 31 weeks of high-dose chemotherapy, followed by 73 weeks of metronomic therapy after completion of high-dose chemotherapy, totaling 104 weeks of metronomic therapy (arm 2).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 158 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study Multicenter Randomized to Assess the Efficacy and Toxicity of Adding Metronomic Therapy to the Standard Treatment of Patients With High Grade Malignant Osteosarcoma With Metastatic Lung Disease at Diagnosis and Primary Resectable Tumor: A Study by the Latin American Group for Treatment of Osteosarcoma
Actual Study Start Date : January 2, 2017
Estimated Primary Completion Date : January 2, 2019
Estimated Study Completion Date : January 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Maintenance therapy
104 weeks of continuous oral low dose chemotherapy with cyclophosphamide (CPM) and methotrexate (MTX) following 31 weeks of MAP
Drug: Cyclophosphamide
Continuous oral cyclophosphamide

Drug: Methotrexate
Continuous oral methotrexate

No Intervention: Control
31 weeks of MAP



Primary Outcome Measures :
  1. Efficacy and toxicity of adding metronomic therapy in disease event-free survival. [ Time Frame: Five years ]
    To assess the impact of adding metronome therapy to the standard treatment of patients with resectable end-stage osteosarcoma and metastatic lung disease in event-free survival.


Secondary Outcome Measures :
  1. Efficacy and toxicity of adding metronomic therapy in overall survival [ Time Frame: Five years ]
    To evaluate the impact of the addition of metronomic therapy to the standard treatment of patients with end-resectable osteosarcoma and metastatic lung disease in overall survival.

  2. Cardiotoxicity (occurrence of cardiotoxicity) [ Time Frame: Five years ]
    To compare the occurrence of cardiotoxicity with the addition of dexrazoxane since the first cycle of doxorubicin with the findings of the previous study (GLATO 2006).

  3. Immunohistochemistry (expression of VEGF) [ Time Frame: Five years ]
    Immunohistochemistry the expression of VEGF in the biopsy, primary tumor and metastases



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Ages Eligible for Study:   up to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A newly diagnosed patient, previously untreated, with a high degree of malignancy, confirmed by biopsy. Participant with OST as a neoplasm are also eligible
  • Participant with staging imaging studies performed less than four weeks. Otherwise, it should be re-staged
  • If pre-chemotherapy amputation is necessary, the participant will enter the study being excluded from the evaluation of tumor necrosis grade according to Huvos, but eligible for survival analysis
  • Participant aged ≥ 16 years should have a Karnofsky performance score> 50 or WHO / ECOG ≥ 2 and patients <16 years should have a Lansky performance score> 50. Participant with a performance score impaired by the presence of a pathological fracture are eligible
  • Patients with normal organic function
  • Sexually active participant should agree to use contraceptive methods throughout the treatment
  • Female participant should have a negative pregnancy test

Exclusion Criteria:

  • If the participant or their legal guardian refuses to sign the informed consent form / consent term it will not be included in the study.

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): NCT03063983


Contacts
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Contact: Antonio S Petrilli +55 (11) 5080-8400 sergiopetrilli@graacc.org.br
Contact: Andreza A Senerchia +55 (11) 5080-8400 andrezasenerchia@graacc.org.br

Locations
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Brazil
Grupo de Apoio ao Adolescente e a Criança com Câncer Recruiting
Sao Paulo, Brazil, 04039001
Contact: Antonio S Petrilli    +55 (11) 5080-8400    sergiopetrilli@graacc.org.br   
Contact: Andreza A Senerchia    +55 (11) 5080-8400    andrezasenerchia@graacc.org.br   
Sponsors and Collaborators
Grupo de Apoio ao Adolescente e a Crianca com Cancer
Investigators
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Study Chair: Cláudia F Fontes Grupo de Apoio ao Adolescente e a Crianca com Cancer
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Responsible Party: Antônio Sérgio Petrilli, Principal Investigator, Grupo de Apoio ao Adolescente e a Crianca com Cancer
ClinicalTrials.gov Identifier: NCT03063983    
Other Study ID Numbers: GLATO2017
First Posted: February 24, 2017    Key Record Dates
Last Update Posted: March 13, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Antônio Sérgio Petrilli, Grupo de Apoio ao Adolescente e a Crianca com Cancer:
osteosarcoma
metastatic
metronomic therapy
Additional relevant MeSH terms:
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Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma
Cyclophosphamide
Methotrexate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Antimetabolites, Antineoplastic
Antimetabolites
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors