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Phase I Study of Vaccination With MPHOSHP1 and DEPDC1 Derived Epitope Peptides for HLA-A-24-positive Patients With Advanced Bladder Cancer


Phase 1
20 Years
80 Years
Not Enrolling
Both
Bladder Cancer

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Trial Information

Phase I Study of Vaccination With MPHOSHP1 and DEPDC1 Derived Epitope Peptides for HLA-A-24-positive Patients With Advanced Bladder Cancer


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

3 years

Safety Issue:

Yes

Principal Investigator

Tomoaki Fujioka, M.D. & Ph.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Department of Urology, Iwate Medical University

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

IMU-H18-59-P1

NCT ID:

NCT00635336

Start Date:

February 2007

Completion Date:

February 2010

Related Keywords:

  • Bladder Cancer
  • Epitope peptide
  • CTL
  • Advanced bladder cancer
  • Vaccination
  • advanced bladder cancer which showed resistance for standard treatments
  • Urinary Bladder Neoplasms

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