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Novel Peptide Vaccination for Patients With Advanced Bladder Cancer

This study has been completed.
Sponsor:
Collaborator:
Human Genome Center, Institute of Medical Science, University of Tokyo
Information provided by:
Iwate Medical University
ClinicalTrials.gov Identifier:
NCT00635336
First received: March 5, 2008
Last updated: October 20, 2010
Last verified: January 2009
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • objective response rate as assessed by RECIST criteria [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • CTL response [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • CD8 population [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Change in level of regulatory T cells [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: March 5, 2008
Last Updated: October 20, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

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
Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014