UMIN-CTR Clinical Trial
| 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 |
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Basic information
Public title
Phase I/II clinical trial of novel peptide-based cancer vaccine IMA901 for patients with advanced renal cell carcinoma
Acronym
Phase I/II clinical trial of peptide-based cancer vaccine IMA901 for patients with renal cell carcinoma
Scientific Title
Phase I/II clinical trial of novel peptide-based cancer vaccine IMA901 for patients with advanced renal cell carcinoma
Scientific Title:Acronym
Phase I/II clinical trial of peptide-based cancer vaccine IMA901 for patients with renal cell carcinoma
Region
| Japan |
Condition
Condition
Renal cell carcinoma
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
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
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
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
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Vaccine |
Interventions/Control_1
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)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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
Key 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
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsuneharu Miki |
Organization
Kyoto Prefectural University of Medicine
Division name
Departments of Urology and Translational Cancer Drug Development
Zip code
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto City, Kyoto, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fumiya Hongo |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Urology
Zip code
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto City, Kyoto, Japan
TEL
075-251-5595
Homepage URL
fhongo@koto.kpu-m.ac.jp
Sponsor or person
Institute
Departments of Urology and Translational Cancer Drug Development, Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
京都府立医科大学附属病院(京都府)
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 12 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 12 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 12 | Month | 22 | Day |
Last modified on
| 2011 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008189
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