Novel Peptide Vaccination for Patients With Advanced Bladder Cancer

NCT00635336 | Completed Phase 1 DMC

• 1 other identifier: IMU-H18-59-P1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bladder Cancer

Keywords

Epitope peptide; CTL; Advanced bladder cancer; Vaccination; advanced bladder cancer which showed resistance for standard treatments

Outcome Measures

Primary Outcomes (1)

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

  3 years

Secondary Outcomes (5)

• objective response rate as assessed by RECIST criteria

  3 years

• CTL response

  3 years

• CD8 population

  3 years

• Change in level of regulatory T cells

  3 years

• survival

  3 years

Interventions

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.

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Iwate Medical University: lead
• Human Genome Center, Institute of Medical Science, University of Tokyo: collaborator

Study Sites (1)

Iwate Medical University School of Medicine

Morioka, Iwate, 020-8505, Japan

Location

Related Publications (6)

• 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.

  PMID: 2679456 BACKGROUND

• 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.

  PMID: 11280777 BACKGROUND

• 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.

  PMID: 12460921 BACKGROUND

• 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.

  PMID: 11057903 BACKGROUND

• 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.

  PMID: 17409436 RESULT

• 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.

  PMID: 17452976 RESULT

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

KIF20B protein, human; DEPDC1 protein, human

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Tomoaki Fujioka, M.D. & Ph.D.

  Department of Urology, Iwate Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 5, 2008
• First Posted: March 13, 2008
• Study Start: February 1, 2007
• Primary Completion: February 1, 2007
• Study Completion: February 1, 2010
• Last Updated: October 21, 2010

Record last verified: 2009-01

Locations

JP (1)