Unique ID issued by UMIN | UMIN000006938 |
---|---|
Receipt number | R000008189 |
Scientific Title | Phase I/II clinical trial of novel peptide-based cancer vaccine IMA901 for patients with advanced renal cell carcinoma |
Date of disclosure of the study information | 2011/12/28 |
Last modified on | 2011/12/22 21:15:20 |
Phase I/II clinical trial of novel peptide-based cancer vaccine IMA901 for patients with advanced renal cell carcinoma
Phase I/II clinical trial of peptide-based cancer vaccine IMA901 for patients with renal cell carcinoma
Phase I/II clinical trial of novel peptide-based cancer vaccine IMA901 for patients with advanced renal cell carcinoma
Phase I/II clinical trial of peptide-based cancer vaccine IMA901 for patients with renal cell carcinoma
Japan |
Renal cell carcinoma
Urology |
Malignancy
NO
Assessment of efficacy and safety of novel peptide-based cancer vaccine IMA901 combined with GM-CSF with low-dose cyclophosphamide pre-treatment for patients with HLA-A*02-positive advanced renal cell carcinoma
Safety,Efficacy
Phase I,II
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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine | Vaccine |
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 microgram) followed by i.d. injections of IMA901 (4.13 mg). This vaccination will be administered 10 times in 14 weeks after starting the vaccination therapy (Day 1, 2, 3, 8, 15, 22, 36, 57, 78, 99)
20 | years-old | <= |
Not applicable |
Male and Female
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
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
15
1st name | |
Middle name | |
Last name | Tsuneharu Miki |
Kyoto Prefectural University of Medicine
Departments of Urology and Translational Cancer Drug Development
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto City, Kyoto, Japan
1st name | |
Middle name | |
Last name | Fumiya Hongo |
Kyoto Prefectural University of Medicine
Department of Urology
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto City, Kyoto, Japan
075-251-5595
fhongo@koto.kpu-m.ac.jp
Departments of Urology and Translational Cancer Drug Development, Kyoto Prefectural University of Medicine
none
Self funding
NO
京都府立医科大学附属病院(京都府)
2011 | Year | 12 | Month | 28 | Day |
Unpublished
Enrolling by invitation
2011 | Year | 12 | Month | 22 | Day |
2012 | Year | 01 | Month | 01 | Day |
2011 | Year | 12 | Month | 22 | Day |
2011 | Year | 12 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008189