Renal cell carcinoma
Conditions
Interventions
A single intravenous infusion of cyclophosphamide (300 mg/ m2) will be administered and then 3 days later patients will start vaccination therapy with intradermal (i.d.) injections of GM-CSF (75 micro
Sponsors
Departments of Urology and Translational Cancer Drug Development, Kyoto Prefectural University of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged at least 20 years 2. HLA type: HLA-A*02-positive 3. Histologically documented advanced clear cell renal cell carcinoma (RCC) 4. Patients who are resistant to standard therapies for RCC and have experienced progressive disease (PD). Documentation of PD must be based on either imaging or clinical tumor progression. 5. At least one measurable target lesion documented by imaging and assessable according to the RECIST criteria 6. Karnofsky performance status >= 80% 7. Able to understand the nature of the study and give written informed consent 8. Willingness and ability to comply with the study protocol for the duration of the study
Exclusion criteria
Exclusion criteria: 1. Immunosuppressive therapy within 4 weeks before starting this therapy, e.g. corticosteroid treatment (exceptions are corticosteroid substitution therapy for adrenal insufficiency or inhalative corticosteroids for e.g. asthma) 2. History of other malignant tumors, except non-melanoma-skin cancer or curatively excised cervical carcinoma in situ 3. Presence of brain metastases on MRI or CT scan 4. Patients with a history or evidence of systemic autoimmune disease 5. Any vaccination in the two weeks before starting this therapy 6. Any planned prophylactic vaccination from study entry until the end of the induction period (5 weeks after the first vaccination) 7. Known active hepatitis B or C infection 8. Known HIV infection 9. Any of the following in the 4 weeks before starting this therapy: a) Major surgery b) Anticancer treatments including cytotoxic chemotherapy, radiotherapy, immunotherapy, hormone therapy, molecular-targeted therapy, or monoclonal antibodies c) Unresolved toxicity from prior anticancer treatments including cytotoxic chemotherapy, hormone therapy, molecular-targeted therapy, monoclonal antibodies, radiotherapy, or immunotherapy d) Received study drug within any clinical study (including approved and experimental drugs) 10. Presence of abnormal function in vital organs 11. Active infections requiring oral or intravenous antibiotics 12. Pregnancy or breastfeeding 13. Any condition which in the judgment of the investigator would place the patient inappropriate to be enrolled in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy and safety of peptide-based cancer vaccine IMA901 combined with GM-CSF and low-dose cyclophosphamide as adjuvant for patients with HLA-A*02-positive advanced renal cell carcinoma | — |
Countries
Japan
Contacts
Public ContactFumiya Hongo
Kyoto Prefectural University of Medicine Department of Urology
Outcome results
None listed