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CAMPFIRE: Children’s and Young Adult Master Protocol for Innovative Pediatric Research - J1S-MC-JAAA

Studio Clinico

Patologia: Sarcomi dei tessuti molli e gist

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: II

Linee di trattamento: Seconda linea, Terza/N linea

Criteri di inclusione: 

· Patients with relapsed, recurrent, or refractory DSRCT.
· Patients with either relapsed, recurrent, or refractory SS.
· Have either measurable or evaluable disease using standard techniques by the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1)(Eisenhauer et al. 2009).
· The patient, or patient’s parent/guardian, has given written informed consent (and assent, as applicable) and authorization for release of health/information for research prior to any study-specific procedures being performed (refer to Appendix 2, Study Governance, Regulatory, and Ethical Considerations).
· The patient has a Lansky (<16 years of age; Lansky et al. 1987) or Karnofsky (≥16 years of age; Karnofsky et al. 1948) performance score of at least 50.
· Patients must have discontinued all previous treatments for cancer or investigational agents ≥7 days after the last dose or as shown below, and must have recovered from the acute effects to ≤Grade 2 for alopecia and decreased tendon reflex and to ≤Grade 1 for all other effects at the time of enrollment, unless otherwise noted. For agents with known AEs occurring beyond the required wait period outlined in the table, this period must be extended until after the time during which the AE is known to occur.
· Patients must be 12 months to ≤29 years of age at the time of study enrollment.
· Patients must have received at least one prior line of systemic treatment, have measurable disease by RECIST 1.1, and must not be eligible for surgical resection at time of enrollment.
· Patients must not have received prior exposure to ramucirumab.
· Adequate cardiac function, defined as: Shortening fraction of ≥27% by echocardiogram, or Ejection fraction of ≥50% by gated radionuclide study.
· Adequate blood pressure (BP) control, defined as: The patient has controlled hypertension defined as systolic BP≤150 mmHg or diastolic BP≤90 mmHg where standard medical management is permitted.

Criteri di esclusione: 

na

Trattamento sperimentale: 

Ramucirumab

Trattamento di controllo: 

/

Centri partecipanti

Nord Italia

IRCCS Istituto Nazionale dei Tumori
Via Venezian 1 - 20133 Milano - MI
Pediatria Oncologica

Riferimento: Dr. Andrea Ferrari
Telefono: 0223902588
Email: andrea.ferrari@istitutotumori.mi.it

 

Istituto Clinico Humanitas Rozzano
Via Manzoni 56 - 20089 Rozzano - MI

 

AOU Padova
Via Nicolò Giustiniani 2 - 35128 Padova - PD
Clinica di Oncoematologia Pediatrica. NB: L'arruolamento dei pazienti non è ancora attivo

 

Centro Italia

Ospedale Pediatrico Bambin Gesù
Piazza Sant Onofrio 4 - 00165 Roma - RM
Unità di Onco-Ematologia - NB: L'arruolamento dei pazienti non è ancora attivo

Informazioni Generali

Protocollo

Numero di iscrizione a registro: na

Data di inserimento: 03.07.2020

Data di aggiornamento: 31.07.2020

Promotore

Eli Lilly and Company

CRO

IQVIA

Principal Investigator ITALIA

Fondazione IRCCS Istituto Nazionale dei Tumori - Milano

Riferimento: Dr. Andrea Ferrari

Telefono: 0223902588

Email: andrea.ferrari@istitutotumori.mi.it

Localita: Milano

 

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