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Novel Peptide Vaccination for Patients With Advanced Bladder Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00635336
First Posted: March 13, 2008
Last Update Posted: October 21, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Human Genome Center, Institute of Medical Science, University of Tokyo
Information provided by:
Iwate Medical University
  Purpose
The purpose of this study is to evaluate the safety and clinical efficacy of novel vaccination for advanced bladder cancer.

Condition Intervention Phase
Bladder Cancer Biological: MPHOSPH1 and DEPDC1 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Vaccination With MPHOSHP1 and DEPDC1 Derived Epitope Peptides for HLA-A-24-positive Patients With Advanced Bladder Cancer

Resource links provided by NLM:


Further study details as provided by Iwate Medical University:

Primary Outcome Measures:
  • feasibility (toxicities as assessed by NCI-CTCAE version 3) [ Time Frame: 3 years ]

Secondary Outcome Measures:
  • objective response rate as assessed by RECIST criteria [ Time Frame: 3 years ]
  • CTL response [ Time Frame: 3 years ]
  • CD8 population [ Time Frame: 3 years ]
  • Change in level of regulatory T cells [ Time Frame: 3 years ]
  • survival [ Time Frame: 3 years ]

Estimated Enrollment: 20
Study Start Date: February 2007
Study Completion Date: February 2010
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: MPHOSPH1 and DEPDC1
    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.
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00635336


Locations
Japan
Iwate Medical University School of Medicine
Morioka, Iwate, Japan, 020-8505
Sponsors and Collaborators
Iwate Medical University
Human Genome Center, Institute of Medical Science, University of Tokyo
Investigators
Study Chair: Tomoaki Fujioka, M.D. & Ph.D. Department of Urology, Iwate Medical University
  More Information

Publications:
Responsible Party: Department of Urology, Iwate Medical University
ClinicalTrials.gov Identifier: NCT00635336     History of Changes
Other Study ID Numbers: IMU-H18-59-P1
First Submitted: March 5, 2008
First Posted: March 13, 2008
Last Update Posted: October 21, 2010
Last Verified: January 2009

Keywords provided by Iwate Medical University:
Epitope peptide
CTL
Advanced bladder cancer
Vaccination
advanced bladder cancer which showed resistance for standard treatments

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs