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Novel Peptide Vaccination for Patients With Advanced Bladder Cancer

Primary Purpose

Bladder Cancer

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
MPHOSPH1 and DEPDC1
Sponsored by
Iwate Medical University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring Epitope peptide, CTL, Advanced bladder cancer, Vaccination, advanced bladder cancer which showed resistance for standard treatments

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

DISEASE CHARACTERISTICS

  1. advanced bladder cancer which already showed resistance to standard treatments
  2. Protein expression of MPHOSPH1 and DEPDC1 on the tumor

PATIENTS CHARACTERISTICS

  1. Patients who showed resistance to standard chemotherapies or radiotherapy
  2. Histological diagnosis is transitional cell carcinoma
  3. HLA-A*2402
  4. ECOG performance status of 0 to 1
  5. Age ≥ 20 years, ≤80 years
  6. WBC≥ 2,000/mm³, ≤15000/mm³ Platelet count ≥ 75000/mm³ AST, ALT ≤150 IU/l Total bilirubin ≤ 3.0 mg/dl Creatinine ≤ 3.0 mg/dl
  7. lesion of bladder cancer must express MPHOSPH1 or DEPDC1
  8. Able and willing to give valid written informed consent

Exclusion Criteria:

  1. Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)
  2. Breastfeeding
  3. Patients willing to childbearing ( Refusal or inability to use effective means of contraception)
  4. Serious infections requiring antibiotics
  5. Concomitant treatment with steroids or immunosuppressing agent
  6. Other malignancy difficult to control.
  7. Decision of unsuitableness by principal investigator or physician-in-charge

Sites / Locations

  • Iwate Medical University School of Medicine

Outcomes

Primary Outcome Measures

feasibility (toxicities as assessed by NCI-CTCAE version 3)

Secondary Outcome Measures

objective response rate as assessed by RECIST criteria
CTL response
CD8 population
Change in level of regulatory T cells
survival

Full Information

First Posted
March 5, 2008
Last Updated
October 20, 2010
Sponsor
Iwate Medical University
Collaborators
Human Genome Center, Institute of Medical Science, University of Tokyo
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1. Study Identification

Unique Protocol Identification Number
NCT00635336
Brief Title
Novel Peptide Vaccination for Patients With Advanced Bladder Cancer
Official Title
Phase I Study of Vaccination With MPHOSHP1 and DEPDC1 Derived Epitope Peptides for HLA-A-24-positive Patients With Advanced Bladder Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Iwate Medical University
Collaborators
Human Genome Center, Institute of Medical Science, University of Tokyo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety and clinical efficacy of novel vaccination for advanced bladder cancer.
Detailed Description
DEP domain containing 1(DEPDC1) and M phase phosphoprotein 1(MPHOSPH1) have been identified using genome-wide expression profile analysis by the use of cDNA microarray in our previous studies. We have determined the HLA-A*2402 restricted epitope peptides derived from DEPDC1, DEPDC1-9-294, and MPHOSPH1, MPHOSPH1-9-278. These epitopes showed strong IFN-g production when stimulated with the appropriate targets expressed the appropriate protein and HLA-A*2402. Furthermore, when vaccinated these peptides, specific CTLs were determined after the vaccination. Therefore we focused on the safety and efficacy of novel vaccination for the advanced bladder cancer patients who already showed resistance to standard chemotherapies or radiotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
Epitope peptide, CTL, Advanced bladder cancer, Vaccination, advanced bladder cancer which showed resistance for standard treatments

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
MPHOSPH1 and DEPDC1
Intervention Description
DEPDC1-9-294, and/or MPHOSPH1-9-278 will be administered by subcutaneously injection once every week for 3 months thereafter once two weeks. These peptides are determined to administer in accordance with the protein expression using immunohistochemical staining. These peptides are conjugated with Montanide ISA 51 as an adjuvant.
Primary Outcome Measure Information:
Title
feasibility (toxicities as assessed by NCI-CTCAE version 3)
Time Frame
3 years
Secondary Outcome Measure Information:
Title
objective response rate as assessed by RECIST criteria
Time Frame
3 years
Title
CTL response
Time Frame
3 years
Title
CD8 population
Time Frame
3 years
Title
Change in level of regulatory T cells
Time Frame
3 years
Title
survival
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: DISEASE CHARACTERISTICS advanced bladder cancer which already showed resistance to standard treatments Protein expression of MPHOSPH1 and DEPDC1 on the tumor PATIENTS CHARACTERISTICS Patients who showed resistance to standard chemotherapies or radiotherapy Histological diagnosis is transitional cell carcinoma HLA-A*2402 ECOG performance status of 0 to 1 Age ≥ 20 years, ≤80 years WBC≥ 2,000/mm³, ≤15000/mm³ Platelet count ≥ 75000/mm³ AST, ALT ≤150 IU/l Total bilirubin ≤ 3.0 mg/dl Creatinine ≤ 3.0 mg/dl lesion of bladder cancer must express MPHOSPH1 or DEPDC1 Able and willing to give valid written informed consent Exclusion Criteria: Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception) Breastfeeding Patients willing to childbearing ( Refusal or inability to use effective means of contraception) Serious infections requiring antibiotics Concomitant treatment with steroids or immunosuppressing agent Other malignancy difficult to control. Decision of unsuitableness by principal investigator or physician-in-charge
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomoaki Fujioka, M.D. & Ph.D.
Organizational Affiliation
Department of Urology, Iwate Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Iwate Medical University School of Medicine
City
Morioka
State/Province
Iwate
ZIP/Postal Code
020-8505
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
2679456
Citation
Rosenberg SA, Lotze MT, Yang JC, Aebersold PM, Linehan WM, Seipp CA, White DE. Experience with the use of high-dose interleukin-2 in the treatment of 652 cancer patients. Ann Surg. 1989 Oct;210(4):474-84; discussion 484-5. doi: 10.1097/00000658-198910000-00008.
Results Reference
background
PubMed Identifier
11280777
Citation
Okabe H, Satoh S, Kato T, Kitahara O, Yanagawa R, Yamaoka Y, Tsunoda T, Furukawa Y, Nakamura Y. Genome-wide analysis of gene expression in human hepatocellular carcinomas using cDNA microarray: identification of genes involved in viral carcinogenesis and tumor progression. Cancer Res. 2001 Mar 1;61(5):2129-37.
Results Reference
background
PubMed Identifier
12460921
Citation
Hasegawa S, Furukawa Y, Li M, Satoh S, Kato T, Watanabe T, Katagiri T, Tsunoda T, Yamaoka Y, Nakamura Y. Genome-wide analysis of gene expression in intestinal-type gastric cancers using a complementary DNA microarray representing 23,040 genes. Cancer Res. 2002 Dec 1;62(23):7012-7.
Results Reference
background
PubMed Identifier
11057903
Citation
Bienz M, Clevers H. Linking colorectal cancer to Wnt signaling. Cell. 2000 Oct 13;103(2):311-20. doi: 10.1016/s0092-8674(00)00122-7. No abstract available.
Results Reference
background
PubMed Identifier
17409436
Citation
Kanehira M, Katagiri T, Shimo A, Takata R, Shuin T, Miki T, Fujioka T, Nakamura Y. Oncogenic role of MPHOSPH1, a cancer-testis antigen specific to human bladder cancer. Cancer Res. 2007 Apr 1;67(7):3276-85. doi: 10.1158/0008-5472.CAN-06-3748.
Results Reference
result
PubMed Identifier
17452976
Citation
Kanehira M, Harada Y, Takata R, Shuin T, Miki T, Fujioka T, Nakamura Y, Katagiri T. Involvement of upregulation of DEPDC1 (DEP domain containing 1) in bladder carcinogenesis. Oncogene. 2007 Sep 27;26(44):6448-55. doi: 10.1038/sj.onc.1210466. Epub 2007 Apr 23.
Results Reference
result

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Novel Peptide Vaccination for Patients With Advanced Bladder Cancer

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