Advanced renal cell carcinoma
Conditions
Interventions
Four-week subcutaneous administration of Sumiferon 6 million units three times a week is followed by oral administration of sorafenib 400 mg bid. The combination therapy with Sumiferon and sorafenib
Sponsors
Osaka Urological Oncology Research Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients diagnosed as having renal cell carcinoma with histopathological clear cell carcinoma components 2.Patients with extrapulmonary metastasis or poor-risk patients in MSKCC risk category 3.Patients with measurable lesions according to the RECIST 4.Patients in whom drug therapy, radiotherapy, or surgical therapy lowered the acute toxicity to Grade 1 or below according to the CTCAE ver. 3.0 5.Patients aged 20 years or older 6.Patients in whom performance status in ECOG (Eastern Cooperative Oncology Group) classification is 0 to 1 7.Patients who are expected to survive for at least 3 months 8.Patients in whom the function of primary organs are retained 9.Female patients who are postmenopausal have consented to contraception or has been surgically sterilized. Male patients who have consented to contraception or received sterilization 10.Patients from whom the informed consent is obtained in writing
Exclusion criteria
Exclusion criteria: 1.Patients who have received systemic therapy for renal carcinoma 2.Patients who completed the surgery or radiotherapy for renal carcinoma less than 4 weeks before initiation of the present study 3.Patients suffering from multiple cancers within last 5 years, excepting those who received appropriate treatment for the following a. Basal cell carcinoma or squamous cell carcinoma of skin b. Uterine cervix carcinoma, gastric cancer or large intestine carcinoma (in situ) 4. Patients who are diagnosed as having cerebral metastasis, meningeal metastasis, spinal cord compression, or meningitis carcinomatosa 5. Patients who are found to have either of the following diseases within 12 months before initiation of the present study Myocardial infarction, severe or unstable angina, coronary or peripheral arterial bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism 6. Patients with arrhythmia (Grade 2 or severer according to the CTCAE ver. 3.0) or atrial fibrillation (regardless of Gragde), or male patients with QTc interval prolonged over 450 msec or female patients with QTc interval prolonged over 470 msec
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