Clinical Trial Evaluating Metronomic Chemotherapy in Patients With Metastatic Osteosarcoma

NCT03063983 | Unknown Phase 2 FDA Drug

• 1 other identifier: GLATO2017
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

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

Conditions

Osteosarcoma

Keywords

osteosarcoma; metastatic; metronomic therapy

Outcome Measures

Primary Outcomes (1)

• Efficacy and toxicity of adding metronomic therapy in disease event-free survival.

  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.

  Five years

Secondary Outcomes (3)

• Efficacy and toxicity of adding metronomic therapy in overall survival

  Five years

• Cardiotoxicity (occurrence of cardiotoxicity)

  Five years

• Immunohistochemistry (expression of VEGF)

  Five years

Study Arms (2)

Maintenance therapy

EXPERIMENTAL

104 weeks of continuous oral low dose chemotherapy with cyclophosphamide (CPM) and methotrexate (MTX) following 31 weeks of MAP

Drug: Cyclophosphamide; Drug: Methotrexate

Control

NO INTERVENTION

31 weeks of MAP

Interventions

Cyclophosphamide DRUG

Continuous oral cyclophosphamide

Maintenance therapy

Methotrexate DRUG

Continuous oral methotrexate

Maintenance therapy

Eligibility Criteria

• Age: 1 Day - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Grupo de Apoio ao Adolescente e a Crianca com Cancer: lead

Study Sites (1)

Grupo de Apoio ao Adolescente e a Criança com Câncer

São Paulo, São Paulo, 04039001, Brazil

RECRUITING

MeSH Terms

Conditions

Osteosarcoma; Neoplasm Metastasis

Interventions

Cyclophosphamide; Methotrexate

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Cláudia F Fontes

  Grupo de Apoio ao Adolescente e a Crianca com Cancer

  STUDY CHAIR

Central Study Contacts

Antonio S Petrilli

CONTACT

+55 (11) 5080-8400; sergiopetrilli@graacc.org.br

Andreza A Senerchia

CONTACT

+55 (11) 5080-8400; andrezasenerchia@graacc.org.br

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 27, 2017
• First Posted: February 24, 2017
• Study Start: January 2, 2017
• Primary Completion: January 2, 2019
• Study Completion: January 31, 2022
• Last Updated: March 13, 2017

Record last verified: 2017-03

Locations

BR (1)