metastatic renal cell carcinoma (mRCC) MedDRA version: 21.1 Level: LLT Classification code 10050076 Term: Metastatic renal carcinoma System Organ Class: 100000004864 MedDRA version: 21.1 Level: LLT Classification code 10015411 Term: Esophageal squamous cell carcinoma lower third stage II System Organ Class: 100000004864 MedDRA version: 21.1 Level: LLT Classification code 10030193 Term: Oesophageal squamous cell carcinoma upper third recurrent System Organ Class: 100000004864
Conditions
Interventions
Trade Name: ENDOXAN BAXTER - 50 MG COMPRESSE RIVESTITE 50 COMPRESSE
Product Name: ENDOXAN
Pharmaceutical Form: Coated tablet
INN or Proposed INN: CICLOFOSFAMIDE
Current Sponsor code: na
Other descript
Sponsors
AZIENDA SANITARIA OSPEDALIERA S.CROCE E CARLE CUNEO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Hystologically confirmed RCC Metastatic disease previously treated with at least three lines of different target therapy. Measurable disease (RECIST criteria 1.1). At least one metastatic site suitable for irradiation. Signed informed consent. Geographical accessibility. Age>=18 y.o. Karnofsky P.S. >= 60 (attachment 1). Life expectancy > 3 months. Adequate bone marrow function (Absolut Neutrophil count >=1,5 x 109/l, platelets>=100 x 109/l, hemoglobin >=10 g/dL). Adequate liver function: transaminases = 2.5 x upper limit of normality (ULN); bilirubin = 1.5 x ULN. Adequate renal function: Creatinine = ULN or creatinine clearance > 60 mL/min (Cockroft-Gault). Adequate contraception for childbearing potential women. Fertil men must be using adequate contraceptive measures throughout the study period and for up to 3 months after the last dose of study treatment if their partner are women of childbearing potential. Adequate cardiac function (LVEF ¿ 50% evaluated by MUGA Scan or Echocardiography and electrocardiogram) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: History of malignant disease (with the exception of non-melanoma skin tumours) in the preceding five years. Prior organ transplantation. Brain metastasis Autoimmune or allergic disorders Previous HBV and/or HCV infections Prior treatment with IL-2. Active steroid therapy Any active infection requiring specific treatment (Antibiotics, antimicotic, antiviral) Radiotherapy within 6 weeks before enrollment. Pregnant or lactating females. Other non-malignant uncontrolled systemic diseases or social conditions that would preclude trial entry in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Objective response rate.;Secondary Objective: Toxicity. QoL. Progression Free Survival. Overall Survival. ;Primary end point(s): Objective response rate.;Timepoint(s) of evaluation of this end point: 30 MONTHS | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Toxicity. QoL. Progression Free Survival. Overall Survival. ; Toxicity; QoL; Progression Free Survival; Overall Survival;Timepoint(s) of evaluation of this end point: UNTIL DEATH; During treatment and during 4 weeks after end of treatment; Every cicle and end of treatment; From study entry to first documented disease progression or death from any cause wichever occurred first; From study entry to death from any cause | — |
Countries
Italy
Contacts
Public ContactUFFICIO SPERIMENTAZIONI CLINICHE
AZIENDA SANITARIA OSPEDALIERA S. CROCE E CARLE DI CUNEO
Outcome results
None listed