Advanced Renal Cell Carcinoma
Conditions
Interventions
Sumiferon 6 million units will be subcutaneously administered three times a week, and treatment will be continued. Judgment for treatment efficacy will be made at least after 12-week treatment. At the
Sponsors
Osaka Urological Oncology Research Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients histopathologically diagnosed as renal cell carcinoma with the presence of clear cell carcinoma 2. Patients with a metastatic focus limited to the lung and/or mediastinal lymph node 3. Patients with the MSKCC risk of favorable or intermediate 4. Patients with a measurable lesion in accordance with RECIST 5. Patients with a history of nephrectomy 6. Patients for whom all of acute toxicities caused by medications, radiotherapy, or surgical procedure in the past have disappeared down to Grade 1 or less of CTCAE ver. 3.0 7. Patients aged at least 20 years 8. Patients whose performance status (ECOG classification) is 0 to 1 9. Patients for whom survival for more than 3 months can be expected 10. Patients for whom functions of organs are maintained 11. Women after menopause or who agree to contraception or is surgically sterile. For men, those who agree to contraception or had an sterilization procedure 12. Patients from whom written consent is obtained
Exclusion criteria
Exclusion criteria: 1.Patients who have had systemic treatment for renal cancer 2.Patients for whom the period after a surgery or the end of radiotherapy is less than 4 weeks at the start of protocol treatment 3.Patients suffering double carcinoma within 5 years. However, the following patients who received appropriate treatment are acceptable as the subjects. a. Basal cell carcinoma of the skin or squamous cell cancer b. Cervical cancer, stomach cancer, or colon cancer (in situ) 4.Patients diagnosed as brain metastasis, spinal cord compression, or meningitis carcinomatosa 5.Patients showing either of the following within 12 months before the start of protocol treatment: Myocardial infarction, severe or unstable angina pectoris, coronary artery or peripheral bypass graft, symptomatic congestive heart failure, cerebrovascular attack or transient ischemic attack, or pulmonary embolism 6.Patients with arrhythmia or atrial fibrillation (any grade) by CTCAE Ver. 3.0, or QTc interval prolongation at >450 msec in men and >470 msec in women 7.Patients with uncontrollable hypertension (>150/100 mmHg in spite of the most proper medication) 8.Patients administered warfarin continuously (oral administration of a low dose of warfarin up to 2 mg/day is acceptable) 9.Patients for whom human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) related diseases or hepatitis B or C virus are confirmed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | — |
Countries
Japan
Contacts
Public ContactMasahiro Nozawa
Osaka Urological Oncology Research Group Executive Office
Outcome results
None listed