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OpenTrials
Completed

NCT Number: NCT00635336

Novel Peptide Vaccination for Patients With Advanced Bladder Cancer

The purpose of this study is to evaluate the safety and clinical efficacy of novel vaccination for advanced bladder cancer.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Iwate Medical University School of Medicine

Morioka, Iwate, 020-8505, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MPHOSPH1 and DEPDC1

Biological

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 outcomes

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

    Time frame: 3 years

Secondary outcomes

  1. objective response rate as assessed by RECIST criteria

    Time frame: 3 years

  2. CTL response

    Time frame: 3 years

  3. CD8 population

    Time frame: 3 years

  4. Change in level of regulatory T cells

    Time frame: 3 years

  5. survival

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Iwate Medical University

Other

Collaborators

  • Human Genome Center, Institute of Medical Science, University of Tokyo

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2007
Study completion
2010
First posted
Mar 13, 2008
Registry last updated
Oct 21, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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